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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
This study is ongoing, but not recruiting participants.
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 Pneumonia
Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride
U.S. FDA Resources
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.:

Estimated Enrollment: 2500
Study Start Date: February 2002
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.

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210639

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications indexed to this study:
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

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
quinolones
levofloxacin
joint diseases
bacterial infections
musculoskeletal diseases
childhood disease

Study placed in the following topic categories:
Bacterial Infections
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Musculoskeletal Diseases
Lung Diseases
Otitis
Joint Diseases
Ofloxacin
Ear Diseases
Pneumonia

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009