Study of Long-Term Antibiotic Treatment in Reactive Arthritis

NCT ID: NCT00621387

Last Updated: 2008-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-11-30
• Study Completion Date: 1998-06-30

Brief 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.

Conditions

Reactive Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

ofloxacin and roxithromycin

Group Type: EXPERIMENTAL

ofloxacin and roxithromycin

Intervention Type: DRUG

150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months

2

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

Interventions

ofloxacin and roxithromycin

150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months

Intervention Type: DRUG

placebo

placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months

Intervention Type: DRUG

Other Intervention Names

Tarivid and Surlid

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: lead

Principal Investigators

Marjatta Leirisalo-Repo, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital

Locations

Division of Rheumatology, Department of Medicine

Helsinki, , Finland

Peijas Hospital

Vantaa, , Finland

Countries

Finland

Other Identifiers

121-853-93

Identifier Type: -

Identifier Source: org_study_id