Study of Long-Term Antibiotic Treatment in Reactive Arthritis

University of Helsinki

Status: Completed

Conditions: Reactive Arthritis

Treatments: Drug: placebo; Drug: ofloxacin and roxithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00621387

121-853-93

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

ofloxacin and roxithromycin

Treatment:

Drug: ofloxacin and roxithromycin

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo