Trial · NCT02257918
Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
NCT02257918, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea. Trials, record NCT02257918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02257918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
- NCT number
- NCT02257918
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Gonorrhoea
- Interventions
- AZD0914, Ceftriaxone
- First posted
- 2014-10-07
- Last updated
- 2017-03-22
- Results first posted
- 2017-02-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm | Day 6 | 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. |
| Primary | Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | Day 1 through Day 31 | 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. |
| Secondary | Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm | Day 6 | 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. |
| Secondary | Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm | Day 6 | 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. |
| Secondary | Number of Participants With Clinical Cure in Each Study Arm | Day 6 | 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. |
| Secondary | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline. | Day 1 (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. |
| Secondary | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6. | Day 6 | 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. |
| Secondary | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm | Baseline and Day 6 | 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. |
| Secondary | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm | Baseline and Day 6 | 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. |
| Secondary | 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 | Day 1 (Baseline) | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm | Day 6 | The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | Day 1 through Day 31 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm | Day 6 | The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm | Day 6 | The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Cure in Each Study Arm | Day 6 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline. | Day 1 (Baseline) | The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6. | Day 6 | The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm | Baseline and Day 6 | The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm | Baseline and Day 6 | The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Day 1 (Baseline) | The analysis population includes all participants who had isolates collected and results reported at the timepoint. | µg/mL | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm | AZD0914/ETX0914 2000mg | 55 | Participants | ||
| Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm | AZD0914/ETX0914 3000mg | 54 | Participants | ||
| Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm | Ceftriaxone 500mg | 28 | Participants | ||
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | AZD0914/ETX0914 2000mg | Related AEs | 9 | Participants | |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | AZD0914/ETX0914 3000mg | Related AEs | 12 | Participants | |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | Ceftriaxone 500mg | Related AEs | 6 | Participants | |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | AZD0914/ETX0914 2000mg | Related SAEs | 0 | Participants | |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | AZD0914/ETX0914 3000mg | Related SAEs | 0 | Participants | |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related. | Ceftriaxone 500mg | Related SAEs | 0 | Participants | |
| Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm | AZD0914/ETX0914 2000mg | 5 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD0914/ETX0914 2000mg | 72 | |
| Overall Study | STARTED | AZD0914/ETX0914 3000mg | 67 | |
| Overall Study | STARTED | Ceftriaxone 500mg | 41 | |
| Overall Study | Test of Cure Visit | AZD0914/ETX0914 2000mg | 72 | |
| Overall Study | Test of Cure Visit | AZD0914/ETX0914 3000mg | 67 | |
| Overall Study | Test of Cure Visit | Ceftriaxone 500mg | 40 | |
| Overall Study | COMPLETED | AZD0914/ETX0914 2000mg | 68 | |
| Overall Study | COMPLETED | AZD0914/ETX0914 3000mg | 66 | |
| Overall Study | COMPLETED | Ceftriaxone 500mg | 39 | |
| Overall Study | NOT COMPLETED | AZD0914/ETX0914 2000mg | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AZD0914/ETX0914 2000mg | 4 | 72 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | AZD0914/ETX0914 3000mg | 2 | 67 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Ceftriaxone 500mg | 3 | 40 | 3 |
| other | Gonorrhea | Infections and infestations | AZD0914/ETX0914 2000mg | 1 | 72 | 1 |
| other | Gonorrhea | Infections and infestations | AZD0914/ETX0914 3000mg | 4 | 67 | 4 |
| other | Gonorrhea | Infections and infestations | Ceftriaxone 500mg | 3 | 40 | 3 |
| other | Headache | Nervous system disorders | AZD0914/ETX0914 2000mg | 0 | 72 | 0 |
| other | Headache | Nervous system disorders | AZD0914/ETX0914 3000mg | 6 | 67 | 6 |
| other | Headache | Nervous system disorders | Ceftriaxone 500mg | 2 | 40 | 2 |
| other | Injection Site Pain | General disorders | AZD0914/ETX0914 2000mg | 0 | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD0914/ETX0914 2000mg | ||
| Total, all-cause mortality | AZD0914/ETX0914 3000mg | ||
| Total, all-cause mortality | Ceftriaxone 500mg | ||
| Total, other adverse events | AZD0914/ETX0914 2000mg | 6 | 72 |
| Total, other adverse events | AZD0914/ETX0914 3000mg | 12 | 67 |
| Total, other adverse events | Ceftriaxone 500mg | 11 | 40 |
| Total, serious adverse events | AZD0914/ETX0914 2000mg | 0 | 72 |
| Total, serious adverse events | AZD0914/ETX0914 3000mg | 1 | 67 |
| Total, serious adverse events | Ceftriaxone 500mg | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30403954 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02257918
GET https://conductscience.org/api/trials/v1/NCT02257918/results?page=2