Trial Outcomes & Findings for Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea (NCT NCT02257918)
NCT ID: NCT02257918
Last Updated: 2017-03-22
Results Overview
Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
COMPLETED
PHASE2
180 participants
Day 6
2017-03-22
Participant Flow
Untreated participants with signs and symptoms of urethral or cervical gonorrhea, or confirmed urethral or cervical gonorrhea as defined by positive culture, NAAT test, or Gram-stain or any type of sexual contact in the past 14 days with an infected individual were enrolled between 25NOV2014 and 02DEC2015.
Participant milestones
| Measure |
AZD0914/ETX0914 2000mg
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
67
|
41
|
|
Overall Study
Test of Cure Visit
|
72
|
67
|
40
|
|
Overall Study
COMPLETED
|
68
|
66
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
AZD0914/ETX0914 2000mg
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
Baseline characteristics by cohort
| Measure |
AZD0914/ETX0914 2000mg
n=72 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=67 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=41 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
67 participants
n=7 Participants
|
41 participants
n=5 Participants
|
180 participants
n=4 Participants
|
|
Positive culture result for N. gonorrhoeae
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 6Population: The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.
Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=57 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=56 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=28 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm
|
55 Participants
|
54 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 31Population: All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.
Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=72 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=67 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=40 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.
Related AEs
|
9 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.
Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.
Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=5 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=7 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=3 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm
|
5 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.
Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=8 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=11 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=4 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm
|
4 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.
A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=57 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=49 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=27 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With Clinical Cure in Each Study Arm
|
52 Participants
|
46 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline)Population: The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.
Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=57 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=56 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=28 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.
Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=57 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=52 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=28 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.
|
48 Participants
|
42 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 6Population: The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.
Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=5 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=7 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=3 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm
Day 6
|
5 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 6Population: The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.
Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=8 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=11 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=4 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm
Day 6
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline)Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint.
For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=57 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=56 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=27 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline
AZD0914/ETX0914
|
0.125 µg/mL
Interval 0.008 to 0.25
|
0.093 µg/mL
Interval 0.008 to 0.25
|
0.060 µg/mL
Interval 0.008 to 0.25
|
|
Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline
Ceftriaxone
|
0.008 µg/mL
Interval 0.001 to 0.03
|
0.008 µg/mL
Interval 0.001 to 0.06
|
0.004 µg/mL
Interval 0.001 to 0.03
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint.
For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=2 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=1 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6
AZD0914/ETX0914
|
0.188 µg/mL
Interval 0.125 to 0.25
|
0.060 µg/mL
Interval 0.06 to 0.06
|
—
|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6
Ceftriaxone
|
0.012 µg/mL
Interval 0.008 to 0.015
|
0.001 µg/mL
Interval 0.001 to 0.001
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline)Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint.
For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=5 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=6 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=3 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline
AZD0914/ETX0914
|
0.060 µg/mL
Interval 0.03 to 0.125
|
0.093 µg/mL
Interval 0.06 to 0.25
|
0.125 µg/mL
Interval 0.008 to 0.25
|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline
Ceftriaxone
|
0.004 µg/mL
Interval 0.001 to 0.015
|
0.008 µg/mL
Interval 0.004 to 0.008
|
0.004 µg/mL
Interval 0.004 to 0.008
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.
For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (Baseline)Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint.
For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=8 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=11 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=4 Participants
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline
Ceftriaxone
|
0.008 µg/mL
Interval 0.001 to 0.03
|
0.008 µg/mL
Interval 0.004 to 0.06
|
0.006 µg/mL
Interval 0.002 to 0.06
|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline
AZD0914/ETX0914
|
0.060 µg/mL
Interval 0.03 to 0.25
|
0.125 µg/mL
Interval 0.008 to 0.25
|
0.093 µg/mL
Interval 0.06 to 0.25
|
SECONDARY outcome
Timeframe: Day 6Population: The analysis population includes all participants who had isolates collected and results reported at the timepoint.
For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
Outcome measures
| Measure |
AZD0914/ETX0914 2000mg
n=4 Participants
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=2 Participants
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6
AZD0914/ETX0914
|
0.125 µg/mL
Interval 0.06 to 0.25
|
0.093 µg/mL
Interval 0.06 to 0.125
|
—
|
|
Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6
Ceftriaxone
|
0.012 µg/mL
Interval 0.004 to 0.03
|
0.012 µg/mL
Interval 0.008 to 0.015
|
—
|
Adverse Events
AZD0914/ETX0914 2000mg
AZD0914/ETX0914 3000mg
Ceftriaxone 500mg
Serious adverse events
| Measure |
AZD0914/ETX0914 2000mg
n=72 participants at risk
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=67 participants at risk
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=40 participants at risk
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/72 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
1.5%
1/67 • Number of events 1 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
0.00%
0/40 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
Other adverse events
| Measure |
AZD0914/ETX0914 2000mg
n=72 participants at risk
Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
|
AZD0914/ETX0914 3000mg
n=67 participants at risk
Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
|
Ceftriaxone 500mg
n=40 participants at risk
Participants receive single intramuscular dose of 500 mg of ceftriaxone.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
4/72 • Number of events 4 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
3.0%
2/67 • Number of events 2 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
7.5%
3/40 • Number of events 3 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
|
Infections and infestations
Gonorrhea
|
1.4%
1/72 • Number of events 1 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
6.0%
4/67 • Number of events 4 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
7.5%
3/40 • Number of events 3 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
|
Nervous system disorders
Headache
|
0.00%
0/72 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
9.0%
6/67 • Number of events 6 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
5.0%
2/40 • Number of events 2 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
|
General disorders
Injection Site Pain
|
—
0/0 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
—
0/0 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
5.0%
2/40 • Number of events 2 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
|
Infections and infestations
Urethritis
|
1.4%
1/72 • Number of events 1 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
0.00%
0/67 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
7.5%
3/40 • Number of events 3 • All serious and non-serious adverse events were collected for 30 days after study product administration
One enrolled participant was not subsequently treated and is not included in the number at risk.
|
Additional Information
Stephanie N. Taylor, MD
Louisiana State University Health Sciences Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60