Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Information source: Helsinki University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Reactive Arthritis
Intervention: ofloxacin and roxithromycin (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Helsinki University Official(s) and/or principal investigator(s): Marjatta Leirisalo-Repo, MD, Principal Investigator, Affiliation: Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
Summary
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.
Clinical Details
Official title: Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of patients recovered from arthritis
Secondary outcome: Swollen joint countTender joint count Ritchie index Joint pain (visual analogue scale) Serum C-reactive protein level Blood erythrocyte sedimentation rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Diagnosis of acute reactive arthritis
2. Preceding infection confirmed by positive culture and/or serology, or with a history
of urethritis or gastroenteritis within the preceding 2 months
3. Age 18 or older
Exclusion Criteria:
1. Allergy to quinolones or macrolides
2. Treatment with systemic corticosteroids within 2 weeks
3. Serum creatinine level elevated over the reference limit
4. Alanine aminotransferase or alkaline phosphatase levels elevated over twice the
reference limit
5. Current or planned pregnancy, or lack of contraception
6. Known HIV positivity
7. Blood leukocyte count less than 4. 0x109/l
8. Blood platelet count less than 100x109/l
9. Lack of co-operation.
Locations and Contacts
Division of Rheumatology, Department of Medicine, Helsinki 00029, Finland
Peijas Hospital, Vantaa 01400, Finland
Additional Information
Starting date: November 1993
Last updated: February 11, 2008
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