Study of Long-Term Antibiotic Treatment in Reactive Arthritis

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.

Official Title
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Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis

Conditions
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Reactive Arthritis

Intervention / Treatment
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* Drug: ofloxacin and roxithromycin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acute reactive arthritis Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months Age 18 or older Exclusion Criteria: Allergy to quinolones or macrolides Treatment with systemic corticosteroids within 2 weeks Serum creatinine level elevated over the reference limit Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit Current or planned pregnancy, or lack of contraception Known HIV positivity Blood leukocyte count less than 4.0x109/l Blood platelet count less than 100x109/l Lack of co-operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ofloxacin and roxithromycin | Drug: ofloxacin and roxithromycin<br>* 150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months<br>* Other names: Tarivid and Surlid;|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients recovered from arthritis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swollen joint count |  | 6 months | 
| Tender joint count |  | 6 months | 
| Ritchie index |  | 6 months | 
| Joint pain (visual analogue scale) |  | 6 months | 
| Serum C-reactive protein level |  | 6 months | 
| Blood erythrocyte sedimentation rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reactive arthritis, antibiotics