Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis) (NCT NCT05630833)

Results Overview

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 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

380 participants

Primary outcome timeframe

At TOC visit (Days 9 to 16)

Results posted on

2025-03-17

Participant Flow

A total of 380 participants were enrolled in the study. Of these, 374 participants were included in the Intent-to-treat (ITT) population. The ITT population excluded 6 participants from a site with Good Clinical Practice (GCP) violation and therefore not a part of analysis population.

Participant milestones

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	286	94
Overall Study ITT Population	281	93
Overall Study Microbiological ITT (Micro-ITT)	88	29
Overall Study Micro-ITT NTF-S	83	25
Overall Study Micro-ITT MDR	18	3
Overall Study Safety	281	93
Overall Study COMPLETED	279	92
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

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	3	0
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gepotidacin n=281 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=93 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=374 Participants Total of all reporting groups
Age, Continuous	44.9 YEARS STANDARD_DEVIATION 18.78 • n=5 Participants	46.4 YEARS STANDARD_DEVIATION 19.21 • n=7 Participants	45.2 YEARS STANDARD_DEVIATION 18.88 • n=5 Participants
Sex: Female, Male Female	281 Participants n=5 Participants	93 Participants n=7 Participants	374 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	281 Participants n=5 Participants	93 Participants n=7 Participants	374 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

PRIMARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT NTF-S population. Participants in micro-ITT population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). Additionally, for the statistical analysis, therapeutic success data from the pooled global studies 204989 (NCT04020341) and 212390 (NCT04187144) were used to derive the predictive distribution, to assess the consistency of gepotidacin's therapeutic success in the current study.

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 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

Outcome measures
Measure	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.	Gepotidacin n=83 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.
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit Therapeutic Failure	—	14 Participants
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit Therapeutic Success	—	69 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT NTF-S Population. Participants in the micro-ITT Population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S).

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 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

Outcome measures
Measure	Nitrofurantoin n=25 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.	Gepotidacin n=83 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.
Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population Therapeutic Success	17 Participants	69 Participants
Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population Therapeutic Failure	8 Participants	14 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT NTF-S Population

Clinical outcome at TOC was 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 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

Outcome measures
Measure	Nitrofurantoin n=25 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.	Gepotidacin n=83 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.
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population Unable To Determine	0 Participants	4 Participants
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population Clinical Resolution	19 Participants	71 Participants
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population Clinical Improvement	4 Participants	5 Participants
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population Clinical Worsening	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At 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

Outcome measures
Measure	Nitrofurantoin n=25 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.	Gepotidacin n=83 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.
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population Clinical Success	19 Participants	71 Participants
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population Clinical Failure	6 Participants	12 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT NTF-S Population

Participant-level MO at TOC was 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

Outcome measures
Measure	Nitrofurantoin n=25 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.	Gepotidacin n=83 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.
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population Microbiological Recurrence (MR)	3 Participants	1 Participants
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population Microbiological Eradication (ME)	20 Participants	74 Participants
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population Microbiological Persistence (MP)	0 Participants	0 Participants
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population Unable To Determine (UTD)	2 Participants	8 Participants

SECONDARY outcome

Timeframe: At 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) 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

Outcome measures
Measure	Nitrofurantoin n=25 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.	Gepotidacin n=83 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.
Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population Microbiological Success	20 Participants	74 Participants
Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population Microbiological Failure	5 Participants	9 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Microbiological intent-to-treat multi drug resistant (Micro-ITT MDR) population included all participants in the micro-ITT Population who had any qualifying baseline bacterial uropathogens that were resistant to two or more classes of antimicrobials.

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 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

Outcome measures
Measure	Nitrofurantoin n=3 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.	Gepotidacin n=18 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.
Number of Participants With Therapeutic Response (TR) at the TOC Visit Therapeutic Success	2 Participants	14 Participants
Number of Participants With Therapeutic Response (TR) at the TOC Visit Therapeutic Failure	1 Participants	4 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT MDR Population

Clinical outcome at TOC was 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 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

Outcome measures
Measure	Nitrofurantoin n=3 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.	Gepotidacin n=18 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.
Number of Participants With Clinical Outcome at the TOC Visit Clinical Resolution	2 Participants	14 Participants
Number of Participants With Clinical Outcome at the TOC Visit Clinical Improvement	0 Participants	2 Participants
Number of Participants With Clinical Outcome at the TOC Visit Clinical Worsening	1 Participants	1 Participants
Number of Participants With Clinical Outcome at the TOC Visit Unable To Determine	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT MDR 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

Outcome measures
Measure	Nitrofurantoin n=3 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.	Gepotidacin n=18 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.
Number of Participants With Clinical Response at the TOC Visit Clinical Success	2 Participants	14 Participants
Number of Participants With Clinical Response at the TOC Visit Clinical Failure	1 Participants	4 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT MDR Population

Participant-level MO at TOC was 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

Outcome measures
Measure	Nitrofurantoin n=3 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.	Gepotidacin n=18 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.
Number of Participants With Microbiological Outcome at the TOC Visit Unable To Determine	1 Participants	2 Participants
Number of Participants With Microbiological Outcome at the TOC Visit Microbiological Eradication	2 Participants	16 Participants
Number of Participants With Microbiological Outcome at the TOC Visit Microbiological Persistence	0 Participants	0 Participants
Number of Participants With Microbiological Outcome at the TOC Visit Microbiological Recurrence	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: Micro-ITT MDR 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) 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

Outcome measures
Measure	Nitrofurantoin n=3 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.	Gepotidacin n=18 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.
Number of Participants With Microbiological Response at the TOC Visit Microbiological Success	2 Participants	16 Participants
Number of Participants With Microbiological Response at the TOC Visit Microbiological Failure	1 Participants	2 Participants

SECONDARY outcome

Timeframe: At TOC visit (Days 9 to 16)

Population: ITT population: All participants (except for 6 participants from the site with GCP violation) were randomly assigned to the study treatment.

Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Number of Participants With Investigator Assessed Clinical Response Indeterminate/Missing	1 Participants	11 Participants
Number of Participants With Investigator Assessed Clinical Response Clinical Success	86 Participants	242 Participants
Number of Participants With Investigator Assessed Clinical Response Clinical Failure	6 Participants	28 Participants

SECONDARY outcome

Timeframe: From first dose (Day 1) to Follow-up visit (Days 21 to 31)

Population: Safety Population included all randomized participants (except for 6 participants from the site with GCP violation) who received 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. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	18 Participants	201 Participants

SECONDARY outcome

Timeframe: From first dose (Day 1) to Follow-up visit (Days 21 to 31)

Population: Safety Population

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. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular \& gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) AE of Special Interest (AESIs)	12 Participants	191 Participants
Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) Serious AE (SAE)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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 Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). 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, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=280 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.
Number of Participants With Urinalysis Dipstick Results KET, On-Therapy, 20 milligrams per deciliter	1 Participants	6 Participants
Number of Participants With Urinalysis Dipstick Results KET, On-Therapy, 5 milligrams per deciliter	7 Participants	22 Participants
Number of Participants With Urinalysis Dipstick Results NIT, Baseline, NEGATIVE	75 Participants	212 Participants
Number of Participants With Urinalysis Dipstick Results NIT, Baseline, POSITIVE	18 Participants	68 Participants
Number of Participants With Urinalysis Dipstick Results NIT, On-Therapy, POSITIVE	3 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results NIT, Test-of-Cure, NEGATIVE	86 Participants	256 Participants
Number of Participants With Urinalysis Dipstick Results NIT, Test-of-Cure, POSITIVE	6 Participants	16 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Baseline, 1000 milligrams per deciliter	19 Participants	43 Participants
Number of Participants With Urinalysis Dipstick Results PRO Baseline, 300 milligrams per deciliter	25 Participants	63 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Baseline, >=5000 milligrams per deciliter	4 Participants	15 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Baseline, NEGATIVE	45 Participants	159 Participants
Number of Participants With Urinalysis Dipstick Results PRO, On-Therapy, 1000 milligrams per deciliter	1 Participants	12 Participants
Number of Participants With Urinalysis Dipstick Results PRO, On-Therapy, 300 milligrams per deciliter	17 Participants	46 Participants
Number of Participants With Urinalysis Dipstick Results PRO, On-Therapy, >=5000 milligrams per deciliter	0 Participants	2 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Test-of-Cure, 1000 milligrams per deciliter	1 Participants	13 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Test-of-Cure, >=5000 milligrams per deciliter	1 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Baseline, 2777.55 micromole per liter	1 Participants	3 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Baseline, >=27775.5 micromole per liter	5 Participants	4 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Baseline, NEGATIVE	87 Participants	273 Participants
Number of Participants With Urinalysis Dipstick Results GLU, On-Therapy, 2777.55 micromole per liter	1 Participants	5 Participants
Number of Participants With Urinalysis Dipstick Results GLU, On-Therapy, 8332.65 micromole per liter	0 Participants	2 Participants
Number of Participants With Urinalysis Dipstick Results GLU, On-Therapy, >=27775.5 micromole per liter	6 Participants	2 Participants
Number of Participants With Urinalysis Dipstick Results GLU, On-Therapy, NEGATIVE	86 Participants	266 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Test-of-Cure, 2777.55 micromole per liter	3 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Test-of-Cure, 8332.65 micromole per liter	0 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Test-of-Cure, >=27775.5 micromole per liter	6 Participants	3 Participants
Number of Participants With Urinalysis Dipstick Results GLU, Test-of-Cure, NEGATIVE	83 Participants	267 Participants
Number of Participants With Urinalysis Dipstick Results KET, Baseline, 20 milligrams per deciliter	1 Participants	10 Participants
Number of Participants With Urinalysis Dipstick Results KET, Baseline, 5 milligrams per deciliter	13 Participants	26 Participants
Number of Participants With Urinalysis Dipstick Results KET, Baseline, NEGATIVE	79 Participants	244 Participants
Number of Participants With Urinalysis Dipstick Results KET, On-Therapy, >=80 milligrams per deciliter	1 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results KET, On-Therapy, NEGATIVE	84 Participants	247 Participants
Number of Participants With Urinalysis Dipstick Results KET, Test-of-Cure, 20 milligrams per deciliter	0 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results KET, Test-of-Cure, 5 milligrams per deciliter	13 Participants	18 Participants
Number of Participants With Urinalysis Dipstick Results KET, Test-of-Cure, NEGATIVE	79 Participants	253 Participants
Number of Participants With Urinalysis Dipstick Results NIT, On-Therapy, NEGATIVE	90 Participants	275 Participants
Number of Participants With Urinalysis Dipstick Results PRO, On-Therapy, NEGATIVE	75 Participants	215 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Test-of-Cure, 300 milligrams per deciliter	11 Participants	24 Participants
Number of Participants With Urinalysis Dipstick Results PRO, Test-of-Cure, NEGATIVE	79 Participants	235 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate CFB to Test-of-Cure	-1.6 beats/minute Standard Deviation 12.90	0.5 beats/minute Standard Deviation 8.44
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate Baseline	70.7 beats/minute Standard Deviation 13.29	67.2 beats/minute Standard Deviation 10.18
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate CFB to On-Therapy	-3.3 beats/minute Standard Deviation 12.41	-0.5 beats/minute Standard Deviation 7.84

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Population: Safety Population. Only those participants with data available at specified time points have been analyzed.

Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF PR, CFB to Test-of-Cure	0.6 Millisecond (msec) Standard Deviation 10.49	0.3 Millisecond (msec) Standard Deviation 10.47
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QRS, Baseline	89.8 Millisecond (msec) Standard Deviation 9.78	88.1 Millisecond (msec) Standard Deviation 10.06
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QT, CFB to On-Therapy	4.8 Millisecond (msec) Standard Deviation 18.78	10.4 Millisecond (msec) Standard Deviation 23.67
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QT, CFB to Test-of-Cure	3.4 Millisecond (msec) Standard Deviation 23.23	-0.7 Millisecond (msec) Standard Deviation 24.53
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF PR, Baseline	159.3 Millisecond (msec) Standard Deviation 16.68	154.9 Millisecond (msec) Standard Deviation 17.88
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF PR, CFB to On-Therapy	1.4 Millisecond (msec) Standard Deviation 9.96	1.6 Millisecond (msec) Standard Deviation 12.18
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QRS, CFB to On-Therapy	0.0 Millisecond (msec) Standard Deviation 3.57	1.2 Millisecond (msec) Standard Deviation 3.77
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QRS, CFB to Test-of-Cure	-0.5 Millisecond (msec) Standard Deviation 3.57	-0.6 Millisecond (msec) Standard Deviation 3.72
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QT, Baseline	401.1 Millisecond (msec) Standard Deviation 28.22	404.5 Millisecond (msec) Standard Deviation 28.16
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QTcF, Baseline	423.2 Millisecond (msec) Standard Deviation 17.25	418.3 Millisecond (msec) Standard Deviation 17.75
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QTcF, CFB to On-Therapy	1.8 Millisecond (msec) Standard Deviation 10.82	10.3 Millisecond (msec) Standard Deviation 13.44
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF QTcF, CFB to Test-of-Cure	3.6 Millisecond (msec) Standard Deviation 11.66	1.3 Millisecond (msec) Standard Deviation 12.09

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Population: Safety Population. Only those participants with data available at specified time points have been 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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Diastolic Blood Pressure, Baseline	74.5 Millimeters of mercury (mmHg) Standard Deviation 12.60	72.8 Millimeters of mercury (mmHg) Standard Deviation 11.98
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Diastolic Blood Pressure, CFB to On-Therapy	-2.1 Millimeters of mercury (mmHg) Standard Deviation 9.36	-2.6 Millimeters of mercury (mmHg) Standard Deviation 9.45
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Diastolic Blood Pressure, CFB to Test-of-Cure	-3.9 Millimeters of mercury (mmHg) Standard Deviation 9.64	-2.4 Millimeters of mercury (mmHg) Standard Deviation 9.76
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Systolic Blood Pressure, Baseline	118.7 Millimeters of mercury (mmHg) Standard Deviation 18.38	118.2 Millimeters of mercury (mmHg) Standard Deviation 18.10
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Systolic Blood Pressure, CFB to On-Therapy	-3.3 Millimeters of mercury (mmHg) Standard Deviation 13.32	-3.1 Millimeters of mercury (mmHg) Standard Deviation 12.20
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Systolic Blood Pressure, CFB to Test-of-Cure	-4.1 Millimeters of mercury (mmHg) Standard Deviation 11.35	-3.7 Millimeters of mercury (mmHg) Standard Deviation 11.63

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Population: Safety Population. Only those participants with data available at specified time points have been 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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Vital Sign: Temperature CFB to On-Therapy	-0.03 Celsius Standard Deviation 0.425	-0.05 Celsius Standard Deviation 0.453
Change From Baseline (CFB) in Vital Sign: Temperature Baseline	36.44 Celsius Standard Deviation 0.365	36.49 Celsius Standard Deviation 0.367
Change From Baseline (CFB) in Vital Sign: Temperature CFB to Test-of-Cure	-0.02 Celsius Standard Deviation 0.396	-0.07 Celsius Standard Deviation 0.397

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Population: Safety Population. Only those participants with data available at specified time points have been 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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Vital Sign: Pulse Rate Baseline	72.2 beats/minute Standard Deviation 10.65	69.7 beats/minute Standard Deviation 10.79
Change From Baseline (CFB) in Vital Sign: Pulse Rate CFB to On-Therapy	1.4 beats/minute Standard Deviation 10.66	2.4 beats/minute Standard Deviation 10.36
Change From Baseline (CFB) in Vital Sign: Pulse Rate CFB to Test-of-Cure	-0.5 beats/minute Standard Deviation 11.54	0.4 beats/minute Standard Deviation 9.30

SECONDARY outcome

Timeframe: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose

Population: Pharmacokinetic (PK) Population included all randomized participants (excluding 6 participants from a site with GCP violation), who received at least 1 dose of Gepotidacin and had at least 1 non-missing plasma concentration (Non-quantifiable values were considered as non-missing). Only those participants with data available at specified time points were analyzed.

Blood samples were collected for plasma concentration of Gepotidacin.

Outcome measures

Outcome measures
Measure	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.	Gepotidacin n=267 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.
Plasma Concentrations of Gepotidacin Baseline, POST-DOSE, Day 1, 0-2h	—	5210.23 Nanogram/ milliliter (ng/mL) Standard Deviation 3428.432
Plasma Concentrations of Gepotidacin Baseline, POST-DOSE, Day 1, >2h	—	5251.54 Nanogram/ milliliter (ng/mL) Standard Deviation 2097.649
Plasma Concentrations of Gepotidacin On-Therapy, PRE-DOSE, Day 2-5, pre-dose	—	1960.14 Nanogram/ milliliter (ng/mL) Standard Deviation 16752.767
Plasma Concentrations of Gepotidacin On-Therapy, POST-DOSE, Day 2-5, 0-2h	—	17548.67 Nanogram/ milliliter (ng/mL) Standard Deviation 124724.240
Plasma Concentrations of Gepotidacin On-Therapy, POST-DOSE, Day 2-5, >2h	—	5976.40 Nanogram/ milliliter (ng/mL) Standard Deviation 5142.635

SECONDARY outcome

Timeframe: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose

Population: Pharmacokinetic (PK) Population included all randomized participants (excluding 6 participants from a site with GCP violation), who received at least 1 dose of Gepotidacin and had at least 1 non-missing urine concentration (Non-quantifiable values were considered as non-missing). Only those participants with data available at specified time points have been analyzed.

Urine samples were collected for urine concentration of Gepotidacin.

Outcome measures

Outcome measures
Measure	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.	Gepotidacin n=250 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.
Urine Concentrations of Gepotidacin On-Therapy, POST-DOSE, Day 2-5, 0-2h	—	901.554 Microgram/ milliliter (ug/mL) Standard Deviation 1451.8781
Urine Concentrations of Gepotidacin On-Therapy, POST-DOSE, Day 2-5, >2h	—	1138.900 Microgram/ milliliter (ug/mL) Standard Deviation 1429.7998
Urine Concentrations of Gepotidacin Baseline, POST-DOSE, Day 1, 0-2h	—	506.988 Microgram/ milliliter (ug/mL) Standard Deviation 914.3140
Urine Concentrations of Gepotidacin Baseline, POST-DOSE, Day 1, >2h	—	600.729 Microgram/ milliliter (ug/mL) Standard Deviation 644.2265
Urine Concentrations of Gepotidacin On-Therapy, PRE-DOSE, Day 2-5, pre-dose	—	492.096 Microgram/ milliliter (ug/mL) Standard Deviation 565.8822

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=85 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.	Gepotidacin n=246 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.
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit CFB to Test-of-Cure	-2.9 Grams per Liter (g/L) Standard Deviation 6.39	-2.3 Grams per Liter (g/L) Standard Deviation 6.22
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit Baseline	128.0 Grams per Liter (g/L) Standard Deviation 10.91	128.6 Grams per Liter (g/L) Standard Deviation 10.70
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit CFB to On-Therapy	-1.0 Grams per Liter (g/L) Standard Deviation 5.61	-1.3 Grams per Liter (g/L) Standard Deviation 6.01

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=85 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.	Gepotidacin n=246 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.
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit Baseline	0.4308 Proportion of red blood cells in blood Standard Deviation 0.05058	0.4355 Proportion of red blood cells in blood Standard Deviation 0.04242
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit CFB to On-Therapy	0.0067 Proportion of red blood cells in blood Standard Deviation 0.03567	-0.0047 Proportion of red blood cells in blood Standard Deviation 0.03252
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit CFB to Test-of-Cure	-0.0038 Proportion of red blood cells in blood Standard Deviation 0.03533	-0.0082 Proportion of red blood cells in blood Standard Deviation 0.03441

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=85 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.	Gepotidacin n=246 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.
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit Baseline	4.245 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.3758	4.302 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.3650
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit CFB to On-Therapy	-0.025 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.1887	-0.040 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.2021
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit CFB to Test-of-Cure	-0.098 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.2218	-0.085 Tera cells per Liter (10^12 cells/L) Standard Deviation 0.2157

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=85 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.	Gepotidacin n=246 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.
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit Baseline	30.26 Picogram (pg) Standard Deviation 2.170	29.97 Picogram (pg) Standard Deviation 2.062
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit CFB to On-Therapy	-0.05 Picogram (pg) Standard Deviation 0.519	-0.03 Picogram (pg) Standard Deviation 0.536
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit CFB to Test-of-Cure	0.00 Picogram (pg) Standard Deviation 0.629	0.04 Picogram (pg) Standard Deviation 0.613

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=85 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.	Gepotidacin n=246 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.
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit Baseline	101.65 Femtoliter (fL) Standard Deviation 10.185	101.48 Femtoliter (fL) Standard Deviation 8.607
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit CFB to On-Therapy	2.40 Femtoliter (fL) Standard Deviation 7.634	-0.16 Femtoliter (fL) Standard Deviation 6.300
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit CFB to Test-of-Cure	1.61 Femtoliter (fL) Standard Deviation 7.071	0.08 Femtoliter (fL) Standard Deviation 6.740

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit Baseline	102.4 Milliequivalents per liter (mEq/L) Standard Deviation 2.38	102.3 Milliequivalents per liter (mEq/L) Standard Deviation 2.21
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit CFB to On-Therapy	0.3 Milliequivalents per liter (mEq/L) Standard Deviation 2.36	0.8 Milliequivalents per liter (mEq/L) Standard Deviation 2.23
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit CFB to Test-of-Cure	0.6 Milliequivalents per liter (mEq/L) Standard Deviation 2.58	1.0 Milliequivalents per liter (mEq/L) Standard Deviation 2.46

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Direct Bilirubin, Baseline	3.4329 micromoles per Liter (umol/L) Standard Deviation 0.10767	3.4498 micromoles per Liter (umol/L) Standard Deviation 0.23845
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Direct Bilirubin, CFB to On-Therapy	-0.0129 micromoles per Liter (umol/L) Standard Deviation 0.10767	-0.0056 micromoles per Liter (umol/L) Standard Deviation 0.24374
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Direct Bilirubin, CFB to Test-of-Cure	-0.0113 micromoles per Liter (umol/L) Standard Deviation 0.11053	-0.0063 micromoles per Liter (umol/L) Standard Deviation 0.20804
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Total Bilirubin, Baseline	6.0420 micromoles per Liter (umol/L) Standard Deviation 3.11713	7.0731 micromoles per Liter (umol/L) Standard Deviation 4.66102
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Total Bilirubin, CFB to On-Therapy	0.3163 micromoles per Liter (umol/L) Standard Deviation 3.23527	-0.4079 micromoles per Liter (umol/L) Standard Deviation 4.14317
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Total Bilirubin, CFB to Test-of-Cure	0.2988 micromoles per Liter (umol/L) Standard Deviation 2.99514	-0.1723 micromoles per Liter (umol/L) Standard Deviation 4.23182
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Creatinine, Baseline	52.280 micromoles per Liter (umol/L) Standard Deviation 11.9212	50.964 micromoles per Liter (umol/L) Standard Deviation 8.7527
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Creatinine, CFB to On-Therapy	-1.426 micromoles per Liter (umol/L) Standard Deviation 6.9325	3.632 micromoles per Liter (umol/L) Standard Deviation 6.6395
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit Creatinine, CFB to Test-of-Cure	0.000 micromoles per Liter (umol/L) Standard Deviation 7.0965	0.620 micromoles per Liter (umol/L) Standard Deviation 7.9007

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit Baseline	1.8690338 Milliliter/second (mL/s) Standard Deviation 0.63944090	1.8346749 Milliliter/second (mL/s) Standard Deviation 0.58199842
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit CFB to On-Therapy	0.0331548 Milliliter/second (mL/s) Standard Deviation 0.28390850	-0.1155781 Milliliter/second (mL/s) Standard Deviation 0.27838072
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit CFB to Test-of-Cure	-0.0111724 Milliliter/second (mL/s) Standard Deviation 0.24923906	-0.0284139 Milliliter/second (mL/s) Standard Deviation 0.27653678

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Albumin, Baseline	44.1 gram per Liter (g/L) Standard Deviation 2.91	44.7 gram per Liter (g/L) Standard Deviation 2.51
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Albumin, CFB to On-Therapy	-0.3 gram per Liter (g/L) Standard Deviation 2.11	-0.4 gram per Liter (g/L) Standard Deviation 2.19
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Albumin, CFB to Test-of-Cure	-1.2 gram per Liter (g/L) Standard Deviation 2.26	-1.3 gram per Liter (g/L) Standard Deviation 2.36
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Protein, Baseline	70.7 gram per Liter (g/L) Standard Deviation 4.46	70.6 gram per Liter (g/L) Standard Deviation 4.18
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Protein, CFB to On-Therapy	-0.7 gram per Liter (g/L) Standard Deviation 3.71	-0.8 gram per Liter (g/L) Standard Deviation 3.50
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit Protein, CFB to Test-of-Cure	-2.3 gram per Liter (g/L) Standard Deviation 3.72	-2.1 gram per Liter (g/L) Standard Deviation 3.80

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALP, Baseline	68.4 International Units per Liter (IU/L) Standard Deviation 22.18	68.9 International Units per Liter (IU/L) Standard Deviation 22.09
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALT, Baseline	16.7 International Units per Liter (IU/L) Standard Deviation 11.11	17.0 International Units per Liter (IU/L) Standard Deviation 16.80
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALT, CFB to On-Therapy	-0.2 International Units per Liter (IU/L) Standard Deviation 3.28	1.2 International Units per Liter (IU/L) Standard Deviation 6.16
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALT, CFB to Test-of-Cure	-1.1 International Units per Liter (IU/L) Standard Deviation 5.98	0.6 International Units per Liter (IU/L) Standard Deviation 12.59
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALP, CFB to On-Therapy	-0.4 International Units per Liter (IU/L) Standard Deviation 8.10	-0.1 International Units per Liter (IU/L) Standard Deviation 6.10
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit ALP, CFB to Test-of-Cure	-3.1 International Units per Liter (IU/L) Standard Deviation 9.28	-2.9 International Units per Liter (IU/L) Standard Deviation 7.12

SECONDARY outcome

Timeframe: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (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

Outcome measures
Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit Baseline	18.7 Units per Liter (U/L) Standard Deviation 7.12	20.1 Units per Liter (U/L) Standard Deviation 17.26
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit CFB to On-Therapy	0.0 Units per Liter (U/L) Standard Deviation 3.85	0.4 Units per Liter (U/L) Standard Deviation 11.28
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit CFB to Test-of-Cure	-0.2 Units per Liter (U/L) Standard Deviation 4.49	0.8 Units per Liter (U/L) Standard Deviation 16.01

Adverse Events

Gepotidacin

Serious events: 2 serious events

Other events: 174 other events

Deaths: 0 deaths

Nitrofurantoin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gepotidacin n=281 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=93 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	0.36% 1/281 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population	0.00% 0/93 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population
Gastrointestinal disorders Vomiting	0.36% 1/281 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population	0.00% 0/93 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population
Infections and infestations Clostridium difficile infection	0.36% 1/281 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population	0.00% 0/93 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population

Other adverse events

Other adverse events
Measure	Gepotidacin n=281 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=93 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	59.4% 167/281 • Number of events 175 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population	7.5% 7/93 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population
Gastrointestinal disorders Nausea	12.5% 35/281 • Number of events 35 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population	2.2% 2/93 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31). Safety Population

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

Measure	Nitrofurantoin n=84 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.	Gepotidacin n=245 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.
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Basophils, Baseline	0.051 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0223	0.050 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0238
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Basophils, CFB to On-Therapy	-0.001 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0152	-0.004 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0194
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Eosinophils, Baseline	0.121 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0977	0.134 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1199
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Eosinophils, CFB to On-Therapy	0.011 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0500	0.008 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0567
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Eosinophils, CFB to Test-of-Cure	0.023 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0630	0.028 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0862
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Lymphocytes, Baseline	1.727 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.5203	1.657 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.5001
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Monocytes, Baseline	0.375 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1394	0.388 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1474
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Monocytes, CFB to On-Therapy	-0.059 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1584	-0.057 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1457
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Platelets, CFB to On-Therapy	2.6 Giga cells per Liter (10^9 cells/L) Standard Deviation 21.53	5.7 Giga cells per Liter (10^9 cells/L) Standard Deviation 25.42
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Platelets, CFB to Test-of-Cure	4.2 Giga cells per Liter (10^9 cells/L) Standard Deviation 37.13	3.3 Giga cells per Liter (10^9 cells/L) Standard Deviation 34.80
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Basophils, CFB to Test-of-Cure	-0.002 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0135	-0.001 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.0192
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Lymphocytes, CFB to On-Therapy	0.075 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.4024	-0.044 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.3958
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Lymphocytes, CFB to Test-of-Cure	0.111 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.4414	-0.054 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.4698
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Monocytes, CFB to Test-of-Cure	-0.033 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1393	-0.049 Giga cells per Liter (10^9 cells/L) Standard Deviation 0.1503
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Neutrophils, Baseline	4.684 Giga cells per Liter (10^9 cells/L) Standard Deviation 2.0992	4.805 Giga cells per Liter (10^9 cells/L) Standard Deviation 2.1102
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Neutrophils, CFB to On-Therapy	-1.477 Giga cells per Liter (10^9 cells/L) Standard Deviation 1.9168	-1.530 Giga cells per Liter (10^9 cells/L) Standard Deviation 1.8841
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Neutrophils, CFB to Test-of-Cure	-1.493 Giga cells per Liter (10^9 cells/L) Standard Deviation 2.1633	-1.713 Giga cells per Liter (10^9 cells/L) Standard Deviation 2.2275
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit Platelets, Baseline	253.6 Giga cells per Liter (10^9 cells/L) Standard Deviation 56.80	261.0 Giga cells per Liter (10^9 cells/L) Standard Deviation 58.37

Measure	Nitrofurantoin n=93 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.	Gepotidacin n=281 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.
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Glucose, CFB to Test-of-Cure	0.156160 millimoles per liter (mmol/L) Standard Deviation 1.2016889	0.057763 millimoles per liter (mmol/L) Standard Deviation 1.1507851
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Potassium, Baseline	4.16 millimoles per liter (mmol/L) Standard Deviation 0.364	4.13 millimoles per liter (mmol/L) Standard Deviation 0.339
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Urea Nitrogen, CFB to Test-of-Cure	0.1177 millimoles per liter (mmol/L) Standard Deviation 0.91259	0.1423 millimoles per liter (mmol/L) Standard Deviation 1.07780
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Calcium, Baseline	2.314716 millimoles per liter (mmol/L) Standard Deviation 0.0868299	2.319018 millimoles per liter (mmol/L) Standard Deviation 0.0816980
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Calcium, CFB to On-Therapy	-0.012341 millimoles per liter (mmol/L) Standard Deviation 0.0695672	-0.004536 millimoles per liter (mmol/L) Standard Deviation 0.0766926
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Calcium, CFB to Test-of-Cure	-0.029885 millimoles per liter (mmol/L) Standard Deviation 0.0860459	-0.032315 millimoles per liter (mmol/L) Standard Deviation 0.0855497
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Glucose, Baseline	5.458483 millimoles per liter (mmol/L) Standard Deviation 1.7589320	5.196605 millimoles per liter (mmol/L) Standard Deviation 1.1351979
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Glucose, CFB to On-Therapy	0.423189 millimoles per liter (mmol/L) Standard Deviation 1.3092369	0.248377 millimoles per liter (mmol/L) Standard Deviation 1.3575780
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Potassium, CFB to On-Therapy	0.02 millimoles per liter (mmol/L) Standard Deviation 0.310	0.05 millimoles per liter (mmol/L) Standard Deviation 0.329
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Potassium, CFB to Test-of-Cure	0.04 millimoles per liter (mmol/L) Standard Deviation 0.370	0.00 millimoles per liter (mmol/L) Standard Deviation 0.365
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Magnesium, Baseline	0.860 millimoles per liter (mmol/L) Standard Deviation 0.0632	0.862 millimoles per liter (mmol/L) Standard Deviation 0.0605
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Magnesium, CFB to On-Therapy	-0.010 millimoles per liter (mmol/L) Standard Deviation 0.0519	-0.004 millimoles per liter (mmol/L) Standard Deviation 0.0555
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Magnesium, CFB to Test-of-Cure	-0.014 millimoles per liter (mmol/L) Standard Deviation 0.0651	-0.010 millimoles per liter (mmol/L) Standard Deviation 0.0569
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Phosphate, Baseline	1.206882 millimoles per liter (mmol/L) Standard Deviation 0.1775576	1.184963 millimoles per liter (mmol/L) Standard Deviation 0.1593757
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Phosphate, CFB to On-Therapy	-0.031943 millimoles per liter (mmol/L) Standard Deviation 0.1706300	0.009746 millimoles per liter (mmol/L) Standard Deviation 0.1600765
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Phosphate, CFB to Test-of-Cure	0.036903 millimoles per liter (mmol/L) Standard Deviation 0.1985578	0.019541 millimoles per liter (mmol/L) Standard Deviation 0.1736731
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Sodium, Baseline	139.8 millimoles per liter (mmol/L) Standard Deviation 2.13	139.8 millimoles per liter (mmol/L) Standard Deviation 2.25
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Sodium, CFB to On-Therapy	-0.2 millimoles per liter (mmol/L) Standard Deviation 2.38	0.1 millimoles per liter (mmol/L) Standard Deviation 2.33
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Sodium, CFB to Test-of-Cure	0.2 millimoles per liter (mmol/L) Standard Deviation 2.42	0.1 millimoles per liter (mmol/L) Standard Deviation 2.52
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Urea Nitrogen, Baseline	4.4145 millimoles per liter (mmol/L) Standard Deviation 1.33139	4.3094 millimoles per liter (mmol/L) Standard Deviation 1.32217
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit Urea Nitrogen, CFB to On-Therapy	-0.1689 millimoles per liter (mmol/L) Standard Deviation 0.85458	-0.0948 millimoles per liter (mmol/L) Standard Deviation 0.98541