Status:
COMPLETED
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Musculoskeletal Diseases
Eligibility:
All Genders
6-16 years
Brief Summary
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
Detailed Description
This is a prospective (look forward using periodic observations collected predominantly following participant enrollment), long-term, comparative, multicenter, observational study (study in which the ...
Eligibility Criteria
Inclusion
- 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
- Participants 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 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)
Key Trial Info
Start Date :
August 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
2233 Patients enrolled
Trial Details
Trial ID
NCT00210639
Start Date
August 1 2002
End Date
May 1 2010
Last Update
April 21 2014
Active Locations (62)
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1
Hoover, Alabama, United States
2
Mobile, Alabama, United States
3
Phoenix, Arizona, United States
4
Tucson, Arizona, United States