Study of Long-Term Antibiotic Treatment in Reactive Arthritis

NCT00621387 | Completed

• 1 other identifier: 121-853-93
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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

Keywords

reactive arthritis; antibiotics

Outcome Measures

Primary Outcomes (1)

• Proportion of patients recovered from arthritis

  6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

1

EXPERIMENTAL

ofloxacin and roxithromycin

Drug: ofloxacin and roxithromycin

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

ofloxacin and roxithromycin DRUG

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

Also known as: Tarivid and Surlid

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (2)

Division of Rheumatology, Department of Medicine

Helsinki, 00029, Finland

Location

Peijas Hospital

Vantaa, 01400, Finland

Location

MeSH Terms

Conditions

Arthritis, Reactive

Interventions

Ofloxacin; Roxithromycin

Condition Hierarchy (Ancestors)

Arthritis, Infectious; Infections; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Marjatta Leirisalo-Repo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: November 1, 1993
• Study Completion: June 1, 1998
• Last Updated: February 22, 2008

Record last verified: 2007-11

Locations

FI (2)