A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection

Completed

• Conditions: Musculoskeletal Diseases
• Interventions: Drug: No intervention

• Registration Number: NCT00210639
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.

Detailed Description

This is a prospective (look forward using periodic observations collected predominantly following participant enrollment), long-term, comparative, multicenter, observational study (study in which the investigators/physicians observe the participants and measure their outcomes) to monitor long-term the incidence of musculoskeletal (MS) disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection. Approximately 2500 participants who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease will be observed in this study. The study consists of 3 phases: a screening phase; a surveillance phase; and a musculoskeletal disorder follow-up phase. Safety evaluations will include assessment of an overall incidence of musculoskeletal disorders that occur during the first 60 days after the first dose of anti-microbial therapy. The specific musculoskeletal disorders to be reported are: tendinopathy (inflammation or rupture of a tendon); arthritis (inflammation of a joint as shown by redness or swelling); arthralgia (pain in a joint); gait abnormality (limping or refusal to walk). Other assessments of safety will include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of participants height over the course of 1 year.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2011-04-26
• Results First Submitted QC: 2011-04-26
• Results First Posted: 2011-05-23
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2233

Inclusion Criteria

• Must have taken at least 1 dose of levofloxacin or standard non-fluoroquinolone therapy as part of a Phase 3 levofloxacin clinical study (LOFBIV-PCAP-003, LOFBO-OTMD-001, LOFBO-OTMD-002) to treat an acute bacterial infection
• Parent or legal guardian read and signed the informed consent form

Exclusion Criteria

• Participants who do not meet the criteria for enrollment in a prior Phase 3 clinical study of levofloxacin or did not take at least one dose of levofloxacin or standard non-fluoroquinolone therapy in 1 of 3 prior Phase 3 levofloxacin clinical studies (LOFBIV-PCAP-003, LOFBO-OTMD-001, or LOFBO-OTMD-002)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparator-treated cohort	No intervention	Participants receiveing comparator in previous levofloxacin studies will be observed.
Levofloxacin-treated cohort	No intervention	Participants receiveing levofloxacin in previous levofloxacin studies will be observed.

Primary Outcome Measures

Name	Time	Method
Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase	Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)	The criteria used to assess Musculoskeletal Adverse Event is based on system organ class "Musculoskeletal and connective tissue disorders" of MedDRA 13.0.