At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,233 enrolled
Drug / intervention
No interventiondrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Completed at least one dose of levofloxacin or standard non-fluoroquinolone therapy in a prior Phase 3 levofloxacin clinical trial (LOFBIV-PCAP-003, LOFBO-OTMD-001, or LOFBO-OTMD-002)
- ✓Informed consent signed by parent or legal guardian
Key exclusion· 1
- ✕Did not complete enrollment in prior Phase 3 levofloxacin studies or did not receive at least one dose of levofloxacin or standard non-fluoroquinolone therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·observational·Posted Sep 21, 2005·Updated Apr 21, 2014
In Brief
An observational study evaluating No intervention for Musculoskeletal Diseases. Completed, enrolled 2,233 participants across 62 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMusculoskeletal Diseases
CountriesArgentina, Brazil, Chile, Costa Rica, Israel, Mexico, Panama, United States
Collaborators--
Timeline
N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
First PostedSep 2005
Primary CompletionApr 2010
Study CompletionMay 2010
TodayJul 2026
First PostedSep 21, 2005
Enrollment StartAug 1, 2002
Primary CompletionApr 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 20.8 years ago
Interventions
No interventiondrug
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.