Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) (NCT NCT04020341)
NCT ID: NCT04020341
Last Updated: 2023-06-22
Results Overview
Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a "microbiological success"(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline \[and no new signs and symptoms\] without the participant receiving other systemic antimicrobials before the TOC Visit). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1531 participants
Primary outcome timeframe
TOC visit (Days 9 to 16)
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
STARTED
|
767
|
764
|
|
Overall Study
Safety Population
|
766
|
760
|
|
Overall Study
Microbiological ITT (Micro ITT) Population
|
401
|
365
|
|
Overall Study
Micro-ITT NTF-S Population
|
336
|
298
|
|
Overall Study
Micro-ITT NTF-S (IA Set) Population
|
320
|
287
|
|
Overall Study
COMPLETED
|
734
|
736
|
|
Overall Study
NOT COMPLETED
|
33
|
28
|
Reasons for withdrawal
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
|
Overall Study
Withdrawal by Subject
|
16
|
16
|
|
Overall Study
Participant not able to swallow the tablet
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
Baseline characteristics by cohort
| Measure |
Gepotidacin
n=767 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Total
n=1531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
49.6 Years
STANDARD_DEVIATION 17.82 • n=5 Participants
|
50.4 Years
STANDARD_DEVIATION 18.17 • n=7 Participants
|
50.0 Years
STANDARD_DEVIATION 17.99 • n=5 Participants
|
|
Age, Customized
Less than (<) 18 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
More than or equal to (>=) 18 years to 50 years
|
372 Participants
n=5 Participants
|
369 Participants
n=7 Participants
|
741 Participants
n=5 Participants
|
|
Age, Customized
More than (>) 50 years
|
389 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
775 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
767 Participants
n=5 Participants
|
764 Participants
n=7 Participants
|
1531 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
278 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
489 Participants
n=5 Participants
|
494 Participants
n=7 Participants
|
983 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
62 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
627 Participants
n=5 Participants
|
621 Participants
n=7 Participants
|
1248 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Acute Cystitis Recurrence
Recurrent Infection
|
312 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
621 Participants
n=5 Participants
|
|
Baseline Acute Cystitis Recurrence
Non-Recurrent Infection
|
455 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
910 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Microbiological intent-to-treat susceptible to nitrofurantoin (micro-ITT NTF-S) (Interim Analysis \[IA\] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures.
Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a "microbiological success"(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline \[and no new signs and symptoms\] without the participant receiving other systemic antimicrobials before the TOC Visit). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=320 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=287 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Therapeutic Success
|
162 Participants
|
135 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Therapeutic Failure
|
158 Participants
|
152 Participants
|
PRIMARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Therapeutic Success
|
174 Participants
|
140 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Therapeutic Failure
|
162 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Unable to determine
|
21 Participants
|
11 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical resolution
|
224 Participants
|
196 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical improvement (CI)
|
82 Participants
|
75 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical worsening (CW)
|
9 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical success
|
224 Participants
|
196 Participants
|
|
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical failure
|
112 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: TOC Visit (Days 9 to 16)Population: Micro-ITT NTF-S population
Participant-level MOs at TOC were categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Eradication (ME)
|
244 Participants
|
199 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Persistence (MP)
|
15 Participants
|
21 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Recurrence (MR)
|
36 Participants
|
52 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Unable to determine (UTD)
|
41 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP)s had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
Microbiological success
|
244 Participants
|
199 Participants
|
|
Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
Microbiological failure
|
92 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit-Micro-ITT NTF-S Population
Therapeutic Failure
|
219 Participants
|
204 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit-Micro-ITT NTF-S Population
Therapeutic Success
|
117 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Sustained clinical resolution (SCR)
|
184 Participants
|
162 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Delayed clinical resolution (DCR)
|
61 Participants
|
44 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical improvement (CI)
|
28 Participants
|
27 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical worsening (CW)
|
12 Participants
|
23 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical recurrence (CR)
|
11 Participants
|
11 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Unable to determine (UTD)
|
40 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical success
|
184 Participants
|
162 Participants
|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical failure
|
152 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Sustained microbiological eradication (SME)
|
174 Participants
|
136 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological persistence (MP)
|
32 Participants
|
38 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological recurrence (MR)
|
36 Participants
|
35 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Delayed microbiological eradication (DME)
|
34 Participants
|
31 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Unable to determine (UTD)
|
60 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
Outcome measures
| Measure |
Gepotidacin
n=336 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=298 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Success
|
174 Participants
|
136 Participants
|
|
Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Failure
|
162 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Intent-to-Treat (ITT) population included all participants randomly assigned to study treatment.
Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=767 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Unable to determine
|
50 Participants
|
37 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical resolution
|
497 Participants
|
484 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical improvement
|
194 Participants
|
206 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical worsening
|
26 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Intent-to-Treat (ITT) population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure.
Outcome measures
| Measure |
Gepotidacin
n=767 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical success
|
497 Participants
|
484 Participants
|
|
Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical failure
|
270 Participants
|
280 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Intent-to-Treat (ITT) population
Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=767 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Sustained clinical resolution (SCR)
|
421 Participants
|
404 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Delayed clinical resolution (DCR)
|
130 Participants
|
127 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical improvement (CI)
|
75 Participants
|
71 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical worsening (CW)
|
29 Participants
|
48 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical recurrence (CR)
|
25 Participants
|
30 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Unable to determine (UTD)
|
87 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Intent-to-Treat (ITT) population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Outcome measures
| Measure |
Gepotidacin
n=767 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical success
|
421 Participants
|
404 Participants
|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical failure
|
346 Participants
|
360 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dosePopulation: Pharmacokinetic (PK) Population included all randomized participants who received at least 1 dose of study treatment and had at least 1 nonmissing plasma or urine PK concentration. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for plasma concentration of gepotidacin.
Outcome measures
| Measure |
Gepotidacin
n=495 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Plasma Concentration of Gepotidacin
Baseline Day 1, 0-2hour (h) post-dose
|
8.52 Microgram/millilitre (ug/mL)
Standard Deviation 84.21
|
—
|
|
Plasma Concentration of Gepotidacin
Baseline Day 1, >2h post-dose
|
2.96 Microgram/millilitre (ug/mL)
Standard Deviation 1.865
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, am, pre-dose
|
3.48 Microgram/millilitre (ug/mL)
Standard Deviation 21.58
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, 0-6h, am, post-dose
|
4.20 Microgram/millilitre (ug/mL)
Standard Deviation 4.210
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, 6-8h, am, post-dose
|
1.22 Microgram/millilitre (ug/mL)
Standard Deviation 0.4729
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, 8-10h, am, post-dose
|
1.10 Microgram/millilitre (ug/mL)
Standard Deviation 1.103
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, 10-12h, am, post-dose
|
1.26 Microgram/millilitre (ug/mL)
Standard Deviation 1.358
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, 0-2h, pm post-dose
|
2.56 Microgram/millilitre (ug/mL)
Standard Deviation 2.717
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 2, >2h, pm, post-dose
|
2.61 Microgram/millilitre (ug/mL)
Standard Deviation 2.579
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 3 to 5, 0-6h post-dose
|
4.10 Microgram/millilitre (ug/mL)
Standard Deviation 3.955
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 3 to 5, 6-8h post-dose
|
2.54 Microgram/millilitre (ug/mL)
Standard Deviation 3.006
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 3 to 5, 8-10h post-dose
|
1.08 Microgram/millilitre (ug/mL)
Standard Deviation 0.9247
|
—
|
|
Plasma Concentration of Gepotidacin
On-Therapy Day 3 to 5, 10-12h post-dose
|
1.17 Microgram/millilitre (ug/mL)
Standard Deviation 1.688
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dosePopulation: Pharmacokinetic (PK) Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected from participants.
Outcome measures
| Measure |
Gepotidacin
n=490 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, 0-6h, am, post-dose
|
781 ug/mL
Standard Deviation 1449
|
—
|
|
Urine Concentration of Gepotidacin
Baseline Day 1, 0-2hour (h) post-dose
|
317 ug/mL
Standard Deviation 680.3
|
—
|
|
Urine Concentration of Gepotidacin
Baseline Day 1, >2h post-dose
|
857 ug/mL
Standard Deviation 1539
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, am, pre-dose
|
391 ug/mL
Standard Deviation 402.5
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, 6-8h, am, post-dose
|
363 ug/mL
Standard Deviation 443.7
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, 8-10h, am, post-dose
|
326 ug/mL
Standard Deviation 274.4
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, 10-12h, am, post-dose
|
287 ug/mL
Standard Deviation 423.2
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, 0-2h, pm post-dose
|
156 ug/mL
Standard Deviation 216.1
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 2, >2h, pm, post-dose
|
624 ug/mL
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 3 to 5, 0-6h post-dose
|
651 ug/mL
Standard Deviation 1313
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 3 to 5, 6-8h post-dose
|
259 ug/mL
Standard Deviation 164.9
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 3 to 5, 8-10h post-dose
|
522 ug/mL
Standard Deviation 663.1
|
—
|
|
Urine Concentration of Gepotidacin
On-Therapy Day 3 to 5, 10-12h post-dose
|
370 ug/mL
Standard Deviation 498.8
|
—
|
SECONDARY outcome
Timeframe: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Outcome measures
| Measure |
Gepotidacin
n=766 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=760 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
266 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
Outcome measures
| Measure |
Gepotidacin
n=766 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=760 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=725 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, Test of Cure
|
0.002 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0204
|
0.001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0244
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, Baseline
|
0.152 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1137
|
0.154 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1338
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, Baseline
|
2.074 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.6603
|
2.133 Giga cells per Liter (10^9 cells/L)
Standard Deviation 2.0797
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, On-Therapy
|
0.009 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4233
|
-0.026 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5333
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, Test of Cure
|
-0.003 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5106
|
0.067 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.6268
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, Baseline
|
0.528 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1808
|
0.529 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1906
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, Test of Cure
|
-0.703 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.7653
|
-0.470 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.7541
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, Baseline
|
278.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 70.32
|
279.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 73.76
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, Baseline
|
0.053 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.217
|
0.055 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0256
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, On-Therapy
|
-0.001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.187
|
0.000 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0204
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, On-Therapy
|
0.013 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0680
|
0.017 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0691
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, Test of Cure
|
0.024 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0770
|
0.022 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0865
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, On-Therapy
|
-0.022 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1445
|
-0.018 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1400
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, Test of Cure
|
-0.022 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1528
|
-0.010 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1678
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, Baseline
|
4.715 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.9781
|
4.640 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.8018
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, On-Therapy
|
-0.540 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.5771
|
-0.519 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.4975
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, On-Therapy
|
2.4 Giga cells per Liter (10^9 cells/L)
Standard Deviation 24.46
|
2.6 Giga cells per Liter (10^9 cells/L)
Standard Deviation 29.94
|
|
Change From Baseline in Hematology Parameters - Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, Test of Cure
|
3.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 39.74
|
8.6 Giga cells per Liter (10^9 cells/L)
Standard Deviation 47.92
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=726 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit
Hemoglobin, Baseline
|
132.2 Gram per Liter (g/L)
Standard Deviation 13.13
|
131.7 Gram per Liter (g/L)
Standard Deviation 14.33
|
|
Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit
Hemoglobin, On-Therapy
|
-0.1 Gram per Liter (g/L)
Standard Deviation 5.27
|
-0.4 Gram per Liter (g/L)
Standard Deviation 6.39
|
|
Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit
Hemoglobin, Test of Cure
|
-0.9 Gram per Liter (g/L)
Standard Deviation 6.63
|
-1.6 Gram per Liter (g/L)
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=726 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Hematocrit, On-Therapy
|
0.0003 Percentage of hematocrit
Standard Deviation 0.02238
|
-0.0007 Percentage of hematocrit
Standard Deviation 0.02431
|
|
Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Hematocrit, Test of Cure
|
-0.0023 Percentage of hematocrit
Standard Deviation 0.02689
|
-0.0055 Percentage of hematocrit
Standard Deviation 0.02757
|
|
Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Hematocrit, Baseline
|
0.4302 Percentage of hematocrit
Standard Deviation 0.04292
|
0.4282 Percentage of hematocrit
Standard Deviation 0.4584
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=726 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Erythrocytes, Baseline
|
4.538 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.4315
|
4.515 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.4324
|
|
Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Erythrocytes, On-Therapy
|
-0.005 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.1900
|
-0.011 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2247
|
|
Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Erythrocytes, Test of Cure
|
-0.033 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2377
|
-0.048 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2528
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=726 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
MCH, On-Therapy
|
0.02 Picogram (pg)
Standard Deviation 0.500
|
-0.03 Picogram (pg)
Standard Deviation 0.536
|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
MCH, Test of Cure
|
0.02 Picogram (pg)
Standard Deviation 0.596
|
-0.05 Picogram (pg)
Standard Deviation 0.644
|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
MCH, Baseline
|
29.20 Picogram (pg)
Standard Deviation 2.392
|
29.24 Picogram (pg)
Standard Deviation 2.499
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=726 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=704 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
MCV, On-Therapy
|
0.17 Femtoliter (fL)
Standard Deviation 3.269
|
0.07 Femtoliter (fL)
Standard Deviation 3.248
|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
MCV, Test of Cure
|
0.17 Femtoliter (fL)
Standard Deviation 3.511
|
-0.019 Femtoliter (fL)
Standard Deviation 3.689
|
|
Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
MCV, Baseline
|
95.02 Femtoliter (fL)
Standard Deviation 7.057
|
95.03 Femtoliter (fL)
Standard Deviation 7.438
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value
Outcome measures
| Measure |
Gepotidacin
n=751 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=741 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Calcium, Baseline
|
2.357 millimoles per liter (mmol/L)
Standard Deviation 0.1118
|
2.374 millimoles per liter (mmol/L)
Standard Deviation 0.1154
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Calcium, On-Therapy
|
-0.009 millimoles per liter (mmol/L)
Standard Deviation 0.0914
|
-0.012 millimoles per liter (mmol/L)
Standard Deviation 0.992
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Calcium, Test of Cure
|
-0.016 millimoles per liter (mmol/L)
Standard Deviation 0.0981
|
-0.016 millimoles per liter (mmol/L)
Standard Deviation 0.1017
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Chloride, Baseline
|
101.6 millimoles per liter (mmol/L)
Standard Deviation 3.23
|
101.3 millimoles per liter (mmol/L)
Standard Deviation 3.08
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Chloride, On-Therapy
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 2.59
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 2.49
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Glucose, Baseline
|
5.778 millimoles per liter (mmol/L)
Standard Deviation 2.3665
|
5.689 millimoles per liter (mmol/L)
Standard Deviation 1.9348
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Glucose, On-Therapy
|
0.199 millimoles per liter (mmol/L)
Standard Deviation 1.4728
|
0.397 millimoles per liter (mmol/L)
Standard Deviation 1.5986
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Glucose, Test of Cure
|
0.156 millimoles per liter (mmol/L)
Standard Deviation 1.5893
|
0.290 millimoles per liter (mmol/L)
Standard Deviation 1.5996
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Magnesium, Baseline
|
0.836 millimoles per liter (mmol/L)
Standard Deviation 0.0760
|
0.831 millimoles per liter (mmol/L)
Standard Deviation 0.0781
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Magnesium, On-Therapy
|
-0.006 millimoles per liter (mmol/L)
Standard Deviation 0.0634
|
-0.015 millimoles per liter (mmol/L)
Standard Deviation 0.0604
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Magnesium, Test of Cure
|
-0.008 millimoles per liter (mmol/L)
Standard Deviation 0.0626
|
-0.014 millimoles per liter (mmol/L)
Standard Deviation 0.0616
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Phosphate, Baseline
|
1.138 millimoles per liter (mmol/L)
Standard Deviation 0.1641
|
1.133 millimoles per liter (mmol/L)
Standard Deviation 0.1750
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Phosphate, On-Therapy
|
0.005 millimoles per liter (mmol/L)
Standard Deviation 0.1642
|
-0.012 millimoles per liter (mmol/L)
Standard Deviation 0.1826
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Phosphate, Test of Cure
|
0.009 millimoles per liter (mmol/L)
Standard Deviation 0.1857
|
0.008 millimoles per liter (mmol/L)
Standard Deviation 0.1908
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Potassium, Baseline
|
4.32 millimoles per liter (mmol/L)
Standard Deviation 0.441
|
4.33 millimoles per liter (mmol/L)
Standard Deviation 0.447
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Potassium, On-Therapy
|
0.00 millimoles per liter (mmol/L)
Standard Deviation 0.443
|
-0.01 millimoles per liter (mmol/L)
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Potassium, Test of Cure
|
0.00 millimoles per liter (mmol/L)
Standard Deviation 0.488
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.495
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Sodium, Baseline
|
139.5 millimoles per liter (mmol/L)
Standard Deviation 2.69
|
139.2 millimoles per liter (mmol/L)
Standard Deviation 2.64
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Sodium, On-Therapy
|
-0.1 millimoles per liter (mmol/L)
Standard Deviation 2.41
|
-0.2 millimoles per liter (mmol/L)
Standard Deviation 2.54
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Sodium, Test of Cure
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 2.68
|
-0.1 millimoles per liter (mmol/L)
Standard Deviation 2.64
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Urea Nitrogen, Baseline
|
4.855 millimoles per liter (mmol/L)
Standard Deviation 1.8877
|
4.912 millimoles per liter (mmol/L)
Standard Deviation 2.1175
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Urea Nitrogen, On-Therapy
|
-0.039 millimoles per liter (mmol/L)
Standard Deviation 1.1285
|
-0.045 millimoles per liter (mmol/L)
Standard Deviation 1.1848
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Urea Nitrogen, Test of Cure
|
0.031 millimoles per liter (mmol/L)
Standard Deviation 1.3613
|
0.054 millimoles per liter (mmol/L)
Standard Deviation 1.5544
|
|
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Serum Chloride, Test of Cure
|
0.4 millimoles per liter (mmol/L)
Standard Deviation 2.88
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=750 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=740 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum direct bilirubin, Baseline
|
4.71 micromoles per Liter (umol/L)
Standard Deviation 1.534
|
4.78 micromoles per Liter (umol/L)
Standard Deviation 1.462
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum direct bilirubin, On-Therapy
|
-0.26 micromoles per Liter (umol/L)
Standard Deviation 1.443
|
-0.16 micromoles per Liter (umol/L)
Standard Deviation 1.276
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum direct bilirubin, Test of cure
|
-0.24 micromoles per Liter (umol/L)
Standard Deviation 1.577
|
-0.08 micromoles per Liter (umol/L)
Standard Deviation 1.534
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum Creatinine, Baseline
|
59.5 micromoles per Liter (umol/L)
Standard Deviation 20.67
|
59.3 micromoles per Liter (umol/L)
Standard Deviation 20.17
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum Creatinine, On-Therapy
|
2.8 micromoles per Liter (umol/L)
Standard Deviation 13.51
|
2.3 micromoles per Liter (umol/L)
Standard Deviation 23.79
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum Creatinine, Test of Cure
|
0.9 micromoles per Liter (umol/L)
Standard Deviation 16.98
|
2.2 micromoles per Liter (umol/L)
Standard Deviation 29.46
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum total bilirubin, Baseline
|
6.72 micromoles per Liter (umol/L)
Standard Deviation 3.914
|
6.77 micromoles per Liter (umol/L)
Standard Deviation 3.909
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum total bilirubin, On-Therapy
|
-0.10 micromoles per Liter (umol/L)
Standard Deviation 2.718
|
-0.15 micromoles per Liter (umol/L)
Standard Deviation 2.655
|
|
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Serum total bilirubin, Test of Cure
|
-0.15 micromoles per Liter (umol/L)
Standard Deviation 2.904
|
-0.16 micromoles per Liter (umol/L)
Standard Deviation 3.107
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=752 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=741 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Albumin, On-Therapy
|
0.0 gram per Liter (g/L)
Standard Deviation 2.21
|
-0.3 gram per Liter (g/L)
Standard Deviation 2.06
|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Protein, Baseline
|
71.6 gram per Liter (g/L)
Standard Deviation 4.73
|
71.8 gram per Liter (g/L)
Standard Deviation 4.72
|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Albumin, Baseline
|
45.2 gram per Liter (g/L)
Standard Deviation 3.07
|
45.4 gram per Liter (g/L)
Standard Deviation 2.91
|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Protein, On-Therapy
|
0.0 gram per Liter (g/L)
Standard Deviation 3.70
|
-0.4 gram per Liter (g/L)
Standard Deviation 3.46
|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Protein, Test of Cure
|
-0.9 gram per Liter (g/L)
Standard Deviation 4.02
|
-1.0 gram per Liter (g/L)
Standard Deviation 3.76
|
|
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Serum Albumin, Test of Cure
|
-0.5 gram per Liter (g/L)
Standard Deviation 2.42
|
-0.5 gram per Liter (g/L)
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=749 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALP, Baseline
|
79.0 Units per Liter (U/L)
Standard Deviation 27.98
|
78.4 Units per Liter (U/L)
Standard Deviation 30.89
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALP, On-Therapy
|
-0.5 Units per Liter (U/L)
Standard Deviation 6.91
|
0.1 Units per Liter (U/L)
Standard Deviation 7.24
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALP, Test of Cure
|
-1.5 Units per Liter (U/L)
Standard Deviation 9.43
|
0.0 Units per Liter (U/L)
Standard Deviation 12.65
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum AST, Baseline
|
20.1 Units per Liter (U/L)
Standard Deviation 9.40
|
21.5 Units per Liter (U/L)
Standard Deviation 16.55
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum AST, On-Therapy
|
0.5 Units per Liter (U/L)
Standard Deviation 5.97
|
0.1 Units per Liter (U/L)
Standard Deviation 5.33
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum AST, Test of Cure
|
1.1 Units per Liter (U/L)
Standard Deviation 7.21
|
1.6 Units per Liter (U/L)
Standard Deviation 38.77
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALT, Baseline
|
18.9 Units per Liter (U/L)
Standard Deviation 13.55
|
20.0 Units per Liter (U/L)
Standard Deviation 17.84
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALT, On-Therapy
|
0.8 Units per Liter (U/L)
Standard Deviation 5.17
|
0.2 Units per Liter (U/L)
Standard Deviation 5.43
|
|
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Serum ALT, Test of Cure
|
1.0 Units per Liter (U/L)
Standard Deviation 8.93
|
1.2 Units per Liter (U/L)
Standard Deviation 23.91
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 mg/dL, 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL and 80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar manner for all other parameters.
Outcome measures
| Measure |
Gepotidacin
n=756 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=752 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Baseline, Negative
|
703 Participants
|
717 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Baseline, 50 mg/dL
|
15 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Baseline, 150 mg/dL
|
4 Participants
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Baseline, >= 500 mg/dL
|
21 Participants
|
15 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, On-Therapy, Negative
|
681 Participants
|
680 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, On-Therapy, 50 mg/dL
|
11 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, On-Therapy, 150 mg/dL
|
7 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, On-Therapy, >= 500 mg/dL
|
22 Participants
|
21 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Test of Cure, Negative
|
672 Participants
|
672 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Test of Cure, 50 mg/dL
|
6 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Test of Cure, >= 500 mg/dL
|
21 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Test of Cure, 100 mg/dL
|
21 Participants
|
15 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Baseline, Negative
|
501 Participants
|
501 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Baseline, 30 mg/dL
|
179 Participants
|
160 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Baseline, 100 mg/dL
|
60 Participants
|
72 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Baseline, >=500 mg/dL
|
3 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, On-Therapy, Negative
|
546 Participants
|
587 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, On-Therapy, 30 mg/dL
|
133 Participants
|
102 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, On-Therapy, 100 mg/dL
|
40 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, On-Therapy, >=500 mg/dL
|
2 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Test of Cure, Negative
|
602 Participants
|
591 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Test of Cure, 30 mg/dL
|
77 Participants
|
89 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
PRO, Test of Cure, >=500 mg/dL
|
1 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Baseline, Negative
|
310 Participants
|
297 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Baseline, Positive
|
2 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Baseline, Small
|
248 Participants
|
266 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Baseline, Moderate
|
118 Participants
|
107 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Baseline, Large
|
72 Participants
|
75 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, On-Therapy, Negative
|
531 Participants
|
475 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, On-Therapy, Small
|
123 Participants
|
167 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, On-Therapy, Moderate
|
38 Participants
|
40 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, On-Therapy, Large
|
29 Participants
|
29 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Test of Cure, Negative
|
503 Participants
|
510 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Test of Cure, Small
|
124 Participants
|
114 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Test of Cure, Moderate
|
46 Participants
|
50 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
BLO, Test of Cure, Large
|
28 Participants
|
26 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Baseline, Negative
|
724 Participants
|
726 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Baseline, 5 mg/dL
|
14 Participants
|
8 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Baseline, 20 mg/dL
|
4 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Baseline, >=80 mg/dL
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, On-Therapy, Negative
|
704 Participants
|
688 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, On-Therapy, 5 mg/dL
|
10 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, On-Therapy, 20 mg/dL
|
6 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, On-Therapy, >=80 mg/dL
|
1 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Test of Cure, Negative
|
683 Participants
|
688 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Test of Cure, 5 mg/dL
|
13 Participants
|
11 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
KET, Test of Cure, >=80 mg/dL
|
5 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, Baseline, Negative
|
466 Participants
|
458 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
GLU, Test of Cure, 150 mg/dL
|
2 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, Baseline, Positive
|
286 Participants
|
291 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, On-Therapy, Negative
|
655 Participants
|
647 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, On-Therapy, Positive
|
66 Participants
|
64 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, Test of Cure, Negative
|
662 Participants
|
639 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
NIT, Test of Cure, Positive
|
39 Participants
|
61 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Negative
|
186 Participants
|
169 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Trace
|
80 Participants
|
77 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Small
|
89 Participants
|
74 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Moderate
|
109 Participants
|
116 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Large
|
292 Participants
|
314 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Baseline, Positive
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, On-Therapy, Negative
|
429 Participants
|
387 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, On-Therapy, Trace
|
82 Participants
|
86 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, On-Therapy, Small
|
48 Participants
|
69 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, On-Therapy, Moderate
|
57 Participants
|
63 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, On-Therapy, Large
|
105 Participants
|
106 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Test of Cure, Negative
|
506 Participants
|
442 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Test of Cure, Trace
|
60 Participants
|
73 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Test of Cure, Small
|
38 Participants
|
54 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Test of Cure, Moderate
|
38 Participants
|
50 Participants
|
|
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
LEU, Test of Cure, Large
|
59 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=742 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=740 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit
Urine Specific Gravity, Baseline
|
1.0168 Ratio
Standard Deviation 0.00639
|
1.0166 Ratio
Standard Deviation 0.00636
|
|
Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit
Urine Specific Gravity, On-Therapy
|
1.0175 Ratio
Standard Deviation 0.00663
|
1.0166 Ratio
Standard Deviation 0.00636
|
|
Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit
Urine Specific Gravity, Test of Cure
|
1.0179 Ratio
Standard Deviation 0.00700
|
1.0179 Ratio
Standard Deviation 0.00701
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=733 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=724 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit
Urine pH, Baseline
|
5.6 pH
Standard Deviation 0.76
|
5.7 pH
Standard Deviation 0.79
|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit
Urine pH, On-Therapy
|
5.6 pH
Standard Deviation 0.68
|
5.6 pH
Standard Deviation 0.73
|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit
Urine pH, Test of Cure
|
5.6 pH
Standard Deviation 0.68
|
5.6 pH
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=766 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=758 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, Baseline
|
123.1 Millimeters of mercury (mmHg)
Standard Deviation 13.23
|
123.4 Millimeters of mercury (mmHg)
Standard Deviation 12.61
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, On-Therapy
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 9.20
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 9.64
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, Test of Cure
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 10.44
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 10.86
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, Baseline
|
76.5 Millimeters of mercury (mmHg)
Standard Deviation 8.36
|
76.7 Millimeters of mercury (mmHg)
Standard Deviation 8.25
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, On-Therapy
|
-0.2 Millimeters of mercury (mmHg)
Standard Deviation 7.48
|
-0.7 Millimeters of mercury (mmHg)
Standard Deviation 7.33
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, Test of Cure
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 7.80
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=765 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=758 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, Baseline
|
73.5 beats per minute (bpm)
Standard Deviation 9.84
|
73.3 beats per minute (bpm)
Standard Deviation 9.91
|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, On-Therapy
|
1.4 beats per minute (bpm)
Standard Deviation 8.39
|
1.7 beats per minute (bpm)
Standard Deviation 8.80
|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, Test of Cure
|
1.2 beats per minute (bpm)
Standard Deviation 9.63
|
1.0 beats per minute (bpm)
Standard Deviation 10.18
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=766 Participants
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=757 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit
Temperature, Baseline
|
36.62 celsius
Standard Deviation 0.372
|
36.62 celsius
Standard Deviation 0.406
|
|
Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit
Temperature, On-Therapy
|
-0.04 celsius
Standard Deviation 0.300
|
-0.04 celsius
Standard Deviation 0.379
|
|
Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit
Temperature, Test of Cure
|
-0.04 celsius
Standard Deviation 0.330
|
-0.07 celsius
Standard Deviation 0.400
|
Adverse Events
Gepotidacin
Serious events: 2 serious events
Other events: 207 other events
Deaths: 0 deaths
Nitrofurantoin
Serious events: 3 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gepotidacin
n=766 participants at risk
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=760 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/766 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/760 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.13%
1/766 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/760 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/766 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/760 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/766 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/760 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.13%
1/766 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/760 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/766 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/760 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/766 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/760 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Gepotidacin
n=766 participants at risk
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=760 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
14.5%
111/766 • Number of events 116 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
3.6%
27/760 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.6%
81/766 • Number of events 84 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
3.8%
29/760 • Number of events 29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
20/766 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.1%
8/760 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
15/766 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.53%
4/760 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
1.8%
14/766 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.53%
4/760 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
10/766 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.39%
3/760 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
2.2%
17/766 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
2.4%
18/760 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
1.4%
11/766 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.1%
8/760 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
8/766 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.66%
5/760 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
8/766 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.66%
5/760 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER