Title
Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
Phase
N/ALead Sponsor
University of HelsinkiStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Reactive ArthritisIntervention/Treatment
roxithromycin ofloxacin ...Study Participants
56This 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.
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
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.
