DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Musculoskeletal Diseases

Intervention: No intervention (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Summary

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

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase

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

Minimum age: 6 Months. Maximum age: 16 Years. Gender(s): Both.

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)

Locations and Contacts

Buenos Aires N/A, Argentina

Buenos Aires, Argentina

Loma Hermosa N/A, Argentina

San Isidro N/A, Argentina

Curitiba, Brazil

Porto Alegre N/A, Brazil

Sao Paulo, Brazil

Santiago, Chile

Costa Rica, Costa Rica

San Jose, Costa Rica

Beer Sheva, Israel

Guadalajara N/A, Mexico

Puebla N/A, Mexico

Toluca N/A, Mexico

Zapopan N/A, Mexico

Zona, Panama

Hoover, Alabama, United States

Mobile, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Madera, California, United States

Oakland, California, United States

Orange, California, United States

Paramount, California, United States

San Luis Obispo, California, United States

West Covina, California, United States

Centennial, Colorado, United States

Denver, Colorado, United States

Chiefland, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Blue Ridge, Georgia, United States

Marietta, Georgia, United States

Aiea, Hawaii, United States

Boise, Idaho, United States

Nampa, Idaho, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Bardstown, Kentucky, United States

Louisville, Kentucky, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Slidell, Louisiana, United States

Detroit, Michigan, United States

Royal Oak, Michigan, United States

Stevensville, Michigan, United States

Omaha, Nebraska, United States

Johnson City, New York, United States

Mineola, New York, United States

New York, New York, United States

Rochester, New York, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Charleston, South Carolina, United States

Corpus Christi, Texas, United States

Houston, Texas, United States

Seguin, Texas, United States

Burke, Virginia, United States

Vienna, Virginia, United States

Additional Information

A long-term study of the incidence of musculoskeletal disorders in children who have received levofloxacin or a standard non-fluoroquinolone therapy for acute bacterial infection

Starting date: August 2002
Last updated: April 2, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017