Trial · NCT00980148
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
NCT00980148, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities. Trials, record NCT00980148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980148
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
- NCT number
- NCT00980148
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 567 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Chlamydial Infection
- Interventions
- Azithromycin, Doxycycline
- First posted
- 2009-09-18
- Last updated
- 2026-08-05
- Results first posted
- 2015-03-18
- Limitations and caveats
- The analysis of the secondary endpoint Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome was limited by the small number of events and is not presented.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized. | Study visit # 2 (Day 28 after therapy started) | The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant). |
| Secondary | Demographical Characteristics of Treatment Failures | Baseline and study visit #2 (Day 28 after therapy is started) | Treatment failure by sex was determined at the first follow-up visit on the basis of nucleic acid amplification testing, sexual history, and outer membrane protein A (OmpA) genotyping of C. trachomatis strains. Strains that were discordant with the infecting strains at baseline were not considered to treatment failure. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized. | Study visit # 2 (Day 28 after therapy started) | The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline. | percentage of participants | NUMBER |
| SECONDARY | Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome. | Baseline and study visit #2 (Day 28 after therapy is started) |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized. | Azithromycin Arm | 3.2 | percentage of participants | ||
Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized. | Doxycycline Arm | 0.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin Arm | 284 | |
| Overall Study | STARTED | Doxycycline Arm | 283 | |
| Overall Study | COMPLETED | Azithromycin Arm | 155 | |
| Overall Study | COMPLETED | Doxycycline Arm | 155 | |
| Overall Study | NOT COMPLETED | Azithromycin Arm | 129 | |
| Overall Study | NOT COMPLETED | Doxycycline Arm | 128 |
Source ClinicalTrials.gov
Adverse events4
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 | Abdominal Pain | Gastrointestinal disorders | Azithromycin Arm | 6 | 155 | 7 |
| other | Abdominal Pain | Gastrointestinal disorders | Doxycycline Arm | 10 | 155 | 10 |
| other | Vomiting | Gastrointestinal disorders | Azithromycin Arm | 6 | 155 | 6 |
| other | Vomiting | Gastrointestinal disorders | Doxycycline Arm | 10 | 155 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin Arm | ||
| Total, all-cause mortality | Doxycycline Arm | ||
| Total, other adverse events | Azithromycin Arm | 11 | 155 |
| Total, other adverse events | Doxycycline Arm | 18 | 155 |
| Total, serious adverse events | Azithromycin Arm | 0 | 155 |
| Total, serious adverse events | Doxycycline Arm | 0 | 155 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26699167 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azithromycin Arm vs Doxycycline Arm: serious adverse events |
Source Trial comparisons
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/NCT00980148
GET https://conductscience.org/api/trials/v1/NCT00980148/registered