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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210639 |
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 |
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 |
Estimated Enrollment: | 2500 |
Study Start Date: | 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.
Ages Eligible for Study: | 6 Months to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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).
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004171 |
Study First Received: | September 13, 2005 |
Last Updated: | December 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00210639 |
Health Authority: | United States: Food and Drug Administration |
quinolones levofloxacin joint diseases |
bacterial infections musculoskeletal diseases childhood disease |
Bacterial Infections Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Musculoskeletal Diseases Lung Diseases |
Otitis Joint Diseases Ofloxacin Ear Diseases Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Infection Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |