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A Long-term Study of the Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-fluoroquinolone Therapy for Acute Bacterial Infection
This study is ongoing, but not recruiting participants.
First Received: September 13, 2005   Last Updated: August 13, 2009   History of Changes
Sponsor: 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
Bacterial Infections
Pneumonia
Otitis
Other: Comparator-treated cohort
Other: Levoflaxacin-treated cohort

Study Type: Observational
Study Design: Cohort, Prospective
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate and compare the overall incidence of MS disorders in pediatric patients that occurred after the first dose of levofloxacin with that of 'standard' nonfluoroquinolone therapy. [ Time Frame: Within 60-day period after the first dose of study medication in the prior Phase 3 tretament protocol. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall incidence of MS disorders including impaired growth in the 1-year period after the first dose. [ Time Frame: 5 visits (1, 2, 3, 6 and 12 months after 1st dose) ] [ Designated as safety issue: Yes ]
  • Incidence of each MS disorder that occurred at weight- and nonweightbearing joints in the 60-day, and 1-year periods after the first dose. [ Time Frame: 5 visits (1, 2, 3, 6 and 12 months after 1st dose) ] [ Designated as safety issue: Yes ]
  • Incidence of each MS disorder in the 60-day period and in the 1-year period, which included impaired growth. [ Time Frame: 5 visits (1, 2, 3, 6 and 12 months after 1st dose) ] [ Designated as safety issue: Yes ]

Study Start Date: February 2002
Estimated Study Completion Date: May 2010
Groups/Cohorts Assigned Interventions
001 Other: Levoflaxacin-treated cohort
Incidence of musculoskeletal disorders
002 Other: Comparator-treated cohort
Incidence of musculoskeletal disorders

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 (MS) 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
Sampling Method:   Probability Sample
Study Population

2523 children, ages 6 months to 16 years, who have received levofloxacin or a standard non-fluoroquinone therapy for acute bacterial infection in one of the Phase 3 interventional trials.

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 & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: ( Senior Director, Compound Development Team Leader )
Study ID Numbers: CR004171
Study First Received: September 13, 2005
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00210639     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Childhood disease
Musculoskeletal diseases
Joint diseases
Levofloxacin
Quinolones
Bacterial infections

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Infection
Ear Diseases
Pharmacologic Actions
Anti-Bacterial Agents
Musculoskeletal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Otitis
Lung Diseases
Nucleic Acid Synthesis Inhibitors
Pneumonia

ClinicalTrials.gov processed this record on February 08, 2010