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

Condition(s) targeted: Otitis; Pneumonia; Bacterial Infections

Intervention: levofloxacin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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

Study design: Screening, Longitudinal, Defined Population, Prospective Study

Detailed description: Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults. In pediatric patients, clinical trials have suggested that levofloxacin is safe and effective for the treatment of a variety of serious infectious diseases. The purpose of this study is to monitor long-term the incidence of musculoskeletal disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection. Patients who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease may be eligible to enroll in this study. The primary assessment of safety is the 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, as shown by complaint of pain or by abnormal movement of the joint); gait abnormality (limping or refusal to walk). Other assessments of safety include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of a patient's height over the course of 1 year. Patients who develop one or more musculoskeletal disorders during the first year will be monitored until they have completed puberty (15th birthday for females and 17th birthday for males). The primary hypothesis is that the levofloxacin group will be comparable to the standard non-fluoroquinolone therapy group in the overall incidence of defined musculoskeletal disorders (tendinopathy, arthritis, arthralgia, and gait abnormality) during the 60-day period after the first dose of antimicrobial therapy.

No study drug is administered in this study.

Minimum age: 6 Months. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: - Patients 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: - Patients 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 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).

Starting date: February 2002
Last updated: December 2, 2005