Clinical trial NCT00210639: A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Keywords: Musculoskeletal Diseases
Musculoskeletal Disorders
Childhood Disease
Bone Diseases
Joint Diseases
Levofloxacin
Quinolones
Bacterial infections
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 2233
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

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)

Primary outcomes:
measure: Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
timeFrame: Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Madera
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Paramount
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: West Covina
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Chiefland
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Blue Ridge
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Aiea
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Nampa
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Stevensville
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Johnson City
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Seguin
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Buenos Aires N/A
country: Argentina
city: Buenos Aires
country: Argentina
city: Loma Hermosa N/A
country: Argentina
city: San Isidro N/A
country: Argentina
city: Curitiba
country: Brazil
city: Porto Alegre N/A
country: Brazil
city: Sao Paulo
country: Brazil
city: Santiago
country: Chile
city: Costa Rica
country: Costa Rica
city: San Jose
country: Costa Rica
city: Beer Sheva
country: Israel
city: Guadalajara N/A
country: Mexico
city: Puebla N/A
country: Mexico
city: Toluca N/A
country: Mexico
city: Zapopan N/A
country: Mexico
city: Zona
country: Panama
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bradley 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.