|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00210639 |
Purpose
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
| Condition | Intervention |
|---|---|
|
Bacterial Infections Pneumonia Otitis |
Other: Comparator-treated cohort Other: Levoflaxacin-treated cohort |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| 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 Start Date: | February 2002 |
| Estimated Study Completion Date: | May 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Other: Levoflaxacin-treated cohort
Incidence of musculoskeletal disorders
|
| 002 |
Other: Comparator-treated cohort
Incidence of musculoskeletal disorders
|
Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults. In pediatric patients, clinical trials have suggested that levofloxacin is safe and effective for the treatment of a variety of serious infectious diseases.The purpose of this study is to monitor long-term the incidence of musculoskeletal (MS) disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection.Patients who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease may be eligible to enroll in this study. The primary assessment of safety is the 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, as shown by complaint of pain or by abnormal movement of the joint); gait abnormality (limping or refusal to walk). Other assessments of safety include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of a patient's height over the course of 1 year. Patients who develop one or more musculoskeletal disorders during the first year will be monitored until they have completed puberty (15th birthday for females and 17th birthday for males). The primary hypothesis is that the levofloxacin group will be comparable to the standard non-fluoroquinolone therapy group in the overall incidence of defined musculoskeletal disorders (tendinopathy, arthritis, arthralgia, and gait abnormality) during the 60-day period after the first dose of antimicrobial therapy. No study drug is administered in this study.
Eligibility| Ages Eligible for Study: | 6 Months to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
2523 children, ages 6 months to 16 years, who have received levofloxacin or a standard non-fluoroquinone therapy for acute bacterial infection in one of the Phase 3 interventional trials.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | ( Senior Director, Compound Development Team Leader ) |
| Study ID Numbers: | CR004171 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00210639 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Childhood disease Musculoskeletal diseases Joint diseases |
Levofloxacin Quinolones Bacterial infections |
|
Bacterial Infections Anti-Infective Agents Communicable Diseases Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Ofloxacin Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Infection Ear Diseases |
Pharmacologic Actions Anti-Bacterial Agents Musculoskeletal Diseases Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Otitis Lung Diseases Nucleic Acid Synthesis Inhibitors Pneumonia |