A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
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
3 other identifiers
observational
2,233
8 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2002
Longer than P75 for all trials
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
May 23, 2011
CompletedApril 21, 2014
April 1, 2014
7.7 years
September 13, 2005
April 26, 2011
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
The criteria used to assess Musculoskeletal Adverse Event is based on system organ class "Musculoskeletal and connective tissue disorders" of MedDRA 13.0.
Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Study Arms (2)
Levofloxacin-treated cohort
Participants receiveing levofloxacin in previous levofloxacin studies will be observed.
Comparator-treated cohort
Participants receiveing comparator in previous levofloxacin studies will be observed.
Interventions
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Eligibility Criteria
Children who have received levofloxacin or a standard non-fluoroquinone therapy for acute bacterial infection in one of the Phase 3 interventional studies will be enrolled in this study.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Hoover, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Madera, California, United States
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Oakland, California, United States
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Orange, California, United States
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Paramount, California, United States
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San Luis Obispo, California, United States
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West Covina, California, United States
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Centennial, Colorado, United States
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Denver, Colorado, United States
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Chiefland, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Blue Ridge, Georgia, United States
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Marietta, Georgia, United States
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‘Aiea, Hawaii, United States
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Boise, Idaho, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Bardstown, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Stevensville, Michigan, United States
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Omaha, Nebraska, United States
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Johnson City, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Seguin, Texas, United States
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Burke, Virginia, United States
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Vienna, Virginia, United States
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Buenos Aires, Argentina
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Loma Hermosa, Argentina
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San Isidro, Argentina
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Curitiba, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Santiago, Chile
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Costa Rica, Costa Rica
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San José, Costa Rica
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Beersheba, Israel
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Guadalajara, Mexico
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Puebla City, Mexico
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Toluca, Mexico
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Zapopan, Mexico
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Zona, Panama
Related Publications (2)
Noel GJ, Bradley JS, Kauffman RE, Duffy CM, Gerbino PG, Arguedas A, Bagchi P, Balis DA, Blumer JL. Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders. Pediatr Infect Dis J. 2007 Oct;26(10):879-91. doi: 10.1097/INF.0b013e3180cbd382.
PMID: 17901792RESULTBradley JS, Kauffman RE, Balis DA, Duffy CM, Gerbino PG, Maldonado SD, Noel GJ. Assessment of musculoskeletal toxicity 5 years after therapy with levofloxacin. Pediatrics. 2014 Jul;134(1):e146-53. doi: 10.1542/peds.2013-3636. Epub 2014 Jun 2.
PMID: 24918220DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was an observational safety study with no efficacy endpoints. Adverse event data is entered into the appropriate section within this submission.
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
August 1, 2002
Primary Completion
April 1, 2010
Study Completion
May 1, 2010
Last Updated
April 21, 2014
Results First Posted
May 23, 2011
Record last verified: 2014-04