N/A
N=207
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
Musculoskeletal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00210639 ↗Enrolled (actual)
207
Serious AEs
2.4%
Results posted
May 2011
Primary outcome: Primary: Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase — 3; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase |
3; 3 | — |
Summary
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
Eligibility Criteria
Inclusion Criteria
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT00210639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.