Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210639
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2005-09-13
Brief Title:
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigatorsphysicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LOFBO-LTSS-001 | OTHER | None | None |
| PRILOF-INT-4 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |