Trial · NCT00351273
Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
NCT00351273, Phase 3, Completed, University of South Florida; results first posted 2016-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria. Trials, record NCT00351273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00351273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
- NCT number
- NCT00351273
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- Arthritis, Reactive, Reiter Disease
- Interventions
- Doxycycline and Rifampin, Azithromycin and Rifampin, Placebo
- First posted
- 2006-07-12
- Last updated
- 2018-11-13
- Results first posted
- 2016-08-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. | Month 6 | The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo. |
| Secondary | Number of Patients With a Complete Response (Resolution of All Symptoms) | Months 6 and 9 | Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit. |
| Secondary | Erythrocyte Sedimentation Rate (ESR) | Baseline Month 1, 3, 6 and 9 | Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9 |
| Secondary | hsCRP | Baseline, Month 1, 3, and 6 | Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6 |
| Secondary | HAQ DI Score | Baseline, Month 1,3,6 and 9 | Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided |
| Secondary | PhGA Assessment | Baseline, month 1,3,6 and 9 | Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9 |
| Secondary | Swollen 76 Joint Count (SJC) | Baseline, month 1,3,6 and 9 | Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score. |
| Secondary | 78 Tender Joint Count (TJC) | Baseline, Month 1, 3, 6 and 9 | Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. | Month 6 | Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders. | participants | NUMBER |
| SECONDARY | Number of Patients With a Complete Response (Resolution of All Symptoms) | Months 6 and 9 | Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Erythrocyte Sedimentation Rate (ESR) | Baseline Month 1, 3, 6 and 9 | millimeters/hour | MEAN | |
| SECONDARY | hsCRP | Baseline, Month 1, 3, and 6 | mg/litre | MEAN | |
| SECONDARY | HAQ DI Score | Baseline, Month 1,3,6 and 9 | score on a scale | MEAN | |
| SECONDARY | PhGA Assessment | Baseline, month 1,3,6 and 9 | units on a scale | MEAN | |
| SECONDARY | Swollen 76 Joint Count (SJC) | Baseline, month 1,3,6 and 9 | Swollen Joints | MEAN | |
| SECONDARY | 78 Tender Joint Count (TJC) | Baseline, Month 1, 3, 6 and 9 | Tender Joints | MEAN |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. | Azithromycin & Rifampin | 10 | participants | ||
| Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. | Doxycycline & Rifampin | 7 | participants | ||
| Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. | Placebo | 3 | participants | ||
| Number of Patients With a Complete Response (Resolution of All Symptoms) | Azithromycin and Rifampin | 5 | Participants | ||
| Number of Patients With a Complete Response (Resolution of All Symptoms) | Doxycycline and Rifampin | 1 | Participants | ||
| Number of Patients With a Complete Response (Resolution of All Symptoms) | Received Placebo | 0 | Participants | ||
| Erythrocyte Sedimentation Rate (ESR) | Combination Antibiotic | Baseline | 25.1 | Full Range 1 to 81 | millimeters/hour |
| Erythrocyte Sedimentation Rate (ESR) | Placebo | Baseline | 18.9 | Full Range 1 to 74 | millimeters/hour |
| Erythrocyte Sedimentation Rate (ESR) | Combination Antibiotic | Month 1 | 17.8 | Full Range 2 to 50 | millimeters/hour |
| Erythrocyte Sedimentation Rate (ESR) | Placebo | Month 1 | 25.2 | Full Range 1 to 78 | millimeters/hour |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin & Rifampin | 15 | |
| Overall Study | STARTED | Doxycycline & Rifampin | 12 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Azithromycin & Rifampin | 14 | |
| Overall Study | COMPLETED | Doxycycline & Rifampin | 10 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Azithromycin & Rifampin | 1 | |
| Overall Study | NOT COMPLETED | Doxycycline & Rifampin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin & Rifampin | ||
| Total, all-cause mortality | Doxycycline & Rifampin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Azithromycin & Rifampin | 0 | 15 |
| Total, other adverse events | Doxycycline & Rifampin | 0 | 12 |
| Total, other adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | Azithromycin & Rifampin | 0 | 15 |
| Total, serious adverse events | Doxycycline & Rifampin | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AR053646 | Combination Antibotics as a Treatment for Chlamydia-Induced Reactive Arthritis | CARTER, JOHN DILLON | UNIVERSITY OF SOUTH FLORIDA | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2006 to 2007 |
Source NIH RePORTER
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/NCT00351273
GET https://conductscience.org/api/trials/v1/NCT00351273/results?page=2