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

Musculoskeletal Diseases Clinical Trial

Official title:

A Multicenter, Long-Term, Active-Surveillance Study of Musculoskeletal Disorders That Occur After Initiating a Course of Levofloxacin (RWJ-25213-097) or Non-Fluoroquinolone Therapy for Acute Infectious Diseases in Children Who Were Enrolled in Phase 3 Clinical Trials Involving Levofloxacin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210639
• Other study ID #: CR004171
• Secondary ID: LOFBO-LTSS-001PR
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 2, 2014
• Start date: August 2002
• Est. completion date: May 2010

Study information

• Verified date: April 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2233
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 16 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Musculoskeletal Diseases

Intervention

Drug:
• No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Costa Rica,  Israel,  Mexico,  Panama, 

References & Publications (1)

Noel GJ, Bradley JS, Kauffman RE, Duffy CM, Gerbino PG, Arguedas A, Bagchi P, Balis DA, Blumer JL. Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders. Pediatr Infect Dis J. 2007 Oct;26(10):8 — View Citation

Outcome

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

External Links

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