Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00351273|
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : August 10, 2016
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Reactive Reiter Disease||Drug: Doxycycline and Rifampin Drug: Azithromycin and Rifampin Drug: Placebo||Phase 3|
The initial infection that causes reactive arthritis is caused by one of two bacteria: Chlamydia trachomatis, which is usually acquired through sexual contact, or Chlamydia pneumoniae, which can cause respiratory infections. Most people recover fully from the initial flare of arthritis symptoms. However, about 20% of people with reactive arthritis experience long-lasting symptoms. In these individuals, the Chlamydia bacteria exist in a persistent metabolically active state within the joint tissue, even years after the initial exposure. The bacteria produce heat shock proteins (HSPs), which are thought to play a key role in the chronic persistent state of Chlamydia and which may stimulate the immune inflammatory response seen in reactive arthritis. This indicates the need for antimicrobial therapy that can reduce Chlamydia's HSP production and block its metabolism. The purpose of this study is to determine the effectiveness of long-term combination antibiotic therapy in treating people with chronic reactive arthritis. The study will use two different combinations of common antibiotics: doxycycline paired with rifampin and azithromycin paired with rifampin.
This study will entail 6 months of treatment followed by 3 months of follow-up. After screening, eligible participants will be randomly assigned to one of three treatment groups: rifampin once a day plus doxycycline twice a day; rifampin once a day plus azithromycin once a day for 5 days, then twice weekly; or placebo. Study visits will occur at baseline and Months 1, 3, 6, and 9. At all visits, participants will undergo an interview, a physical examination, and blood collection. They will also complete a questionnaire related to their symptoms and functional status. At screening and Month 6, a synovial biopsy may be performed. This will involve taking a sample of the tissue that lines the joints.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase 3 Trial to Assess the Efficacy of Long-term (6 Months) Combination Antibiotics as a Treatment for Chlamydia-induced Reactive Arthritis|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Active Comparator: Azithromycin and Rifampin
Participants received Azithromycin and Rifampin
Drug: Azithromycin and Rifampin
Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months)
Other Name: Zithromax and Rifadin
Active Comparator: Doxycycline and Rifampin
Participants received Doxycycline and Rifampin
Drug: Doxycycline and Rifampin
doxycycline 100mg daily; rifampin 300mg daily (both for 6 months)
Other Name: Atridox and Rifadin
Placebo Comparator: received placebo
Participants received placebo
Other Name: Placebo effect
- Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. [ Time Frame: 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.
- Number of Patients With a Complete Response (Resolution of All Symptoms) [ Time Frame: 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.
- Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 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
- hsCRP [ Time Frame: 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
- HAQ DI Score [ Time Frame: 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
- PhGA Assessment [ Time Frame: 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
- Swollen 76 Joint Count (SJC) [ Time Frame: 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.
- 78 Tender Joint Count (TJC) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351273
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|United States, Louisiana|
|Louisiana State University|
|New Orleans, Louisiana, United States, 70112|
|University of Toronto|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||John D. Carter, MD||University of South Florida|