This study is no longer recruiting patients.

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

Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier: NCT00210639

Purpose

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

Condition Intervention Phase

Otitis

Pneumonia

Bacterial Infections

Drug: levofloxacin

Phase III

MedlinePlus related topics: Bacterial Infections; Ear Disorders; Pneumonia

Study Type: Observational

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

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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Expected Total Enrollment: 2500

Study start: February 2002

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.

Eligibility

Ages Eligible for Study: 6 Months - 16 Years, Genders Eligible for Study: 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).

Location Information

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Study ID Numbers: CR004171

Last Updated: December 2, 2005

Record first received: September 13, 2005

ClinicalTrials.gov Identifier: NCT00210639

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on 2006-06-09