Musculoskeletal DiseasesNCT00210639
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
An observational study of Musculoskeletal Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 62 sites in 8 countries.
Trial summary
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Musculoskeletal Diseases
- How many people
- 2,233 participants
- Where
- 62 sitesin 8 countries
- Study dates
- Aug 2002to May 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
62 sites in 8 countries.
62 sites in 8 countries
United States47 sites
Study site
‘Aiea, Hawaii
Study site
Akron, Ohio
Study site
Bardstown, Kentucky
Study site
Blue Ridge, Georgia
Study site
Boise, Idaho
Study site
Burke, Virginia
Study site
Centennial, Colorado
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Chiefland, Florida
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Corpus Christi, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Hollywood, Florida
Study site
Hoover, Alabama
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Johnson City, New York
Study site
Louisville, Kentucky
Study site
Madera, California
Study site
Marietta, Georgia
Study site
Metairie, Louisiana
Study site
Mineola, New York
Study site
Mobile, Alabama
Study site
Nampa, Idaho
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Oakland, California
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Paramount, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Rochester, New York
Study site
Royal Oak, Michigan
Study site
San Luis Obispo, California
Study site
Seguin, Texas
Study site
Shreveport, Louisiana
Study site
Slidell, Louisiana
Study site
Stevensville, Michigan
Study site
Tucson, Arizona
Study site
Vienna, Virginia
Study site
West Covina, California
Mexico4 sites
Study site
Guadalajara
Study site
Puebla City
Study site
Toluca
Study site
Zapopan
Argentina3 sites
Study site
Buenos Aires
Study site
Loma Hermosa
Study site
San Isidro
About this study
Official title: 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
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
Read the 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 investigators/physicians observe the participants and measure their outcomes) to monitor long-term the incidence of musculoskeletal (MS) disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection. Approximately 2500 participants who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease will be observed in this study. The study consists of 3 phases: a screening phase; a surveillance phase; and a musculoskeletal disorder follow-up phase. Safety evaluations will include assessment of an overall incidence of musculoskeletal disorders that occur during the first 60 days after the first dose of anti-microbial therapy. The specific musculoskeletal disorders to be reported are: tendinopathy (inflammation or rupture of a tendon); arthritis (inflammation of a joint as shown by redness or swelling); arthralgia (pain in a joint); gait abnormality (limping or refusal to walk). Other assessments of safety will include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of participants height over the course of 1 year.
- Conditions
- Musculoskeletal Diseases
- Being tested
- No intervention
- Keywords
- Musculoskeletal Diseases, Musculoskeletal Disorders, Childhood Disease, Bone Diseases, Joint Diseases, Levofloxacin, Quinolones, Bacterial infections
- Medical subject headings
- Musculoskeletal Diseases, Bone Diseases, Joint Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin-treated cohort | Participants receiveing levofloxacin in previous levofloxacin studies will be observed. Receives: Drug: No intervention | |
| Comparator-treated cohort | Participants receiveing comparator in previous levofloxacin studies will be observed. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210639
- Sponsor's protocol ID
- CR004171
- Other IDs
- LOFBO-LTSS-001, PRI/LOF-INT-4
- Status last verified
- Apr 2014
- First submitted
- 13 Sep 2005
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17901792Bradley 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.
PubMed 24918220