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

April 2, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Buenos Aires N/A, Argentina
      • Loma Hermosa N/A, Argentina
      • San Isidro N/A, Argentina
  • Brazil
      • Curitiba, Brazil
      • Porto Alegre N/A, Brazil
      • Sao Paulo, Brazil
  • Chile
      • Santiago, Chile
  • Costa Rica
      • Costa Rica, Costa Rica
      • San Jose, Costa Rica
  • Israel
      • Beer Sheva, Israel
  • Mexico
      • Guadalajara N/A, Mexico
      • Puebla N/A, Mexico
      • Toluca N/A, Mexico
      • Zapopan N/A, Mexico
  • Panama
      • Zona, Panama
  • United States
    • Alabama
      • Hoover, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • 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
    • Colorado
      • Centennial, Colorado, United States
      • Denver, Colorado, United States
    • Florida
      • Chiefland, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
    • Georgia
      • Blue Ridge, Georgia, United States
      • Marietta, Georgia, United States
    • Hawaii
      • Aiea, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
      • Nampa, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Bardstown, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
      • Slidell, Louisiana, United States
    • Michigan
      • Detroit, Michigan, United States
      • Royal Oak, Michigan, United States
      • Stevensville, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Johnson City, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Houston, Texas, United States
      • Seguin, Texas, United States
    • Virginia
      • Burke, Virginia, United States
      • Vienna, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Levofloxacin-treated cohort
Participants receiveing levofloxacin in previous levofloxacin studies will be observed.
Drug: No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Comparator-treated cohort
Participants receiveing comparator in previous levofloxacin studies will be observed.
Drug: No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
Time Frame: Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004171
  • LOFBO-LTSS-001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
  • PRI/LOF-INT-4 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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