A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection

Completed

Conditions studied: Musculoskeletal Diseases

In brief

The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.

Key facts

Study ID

NCT00210639

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

2233

Starts

2002-08-01

Expected to finish

2010-05-01

Last updated by the study team

2014-04-21

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Madera, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Paramount, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — West Covina, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Chiefland, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Blue Ridge, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — ‘Aiea, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Nampa, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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