A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00210639 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Results First Posted : May 23, 2011
Last Update Posted : April 21, 2014
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Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Musculoskeletal Diseases | Drug: No intervention |
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 |
| Actual Enrollment : | 2233 participants |
| Observational Model: | Cohort |
| Time Perspective: | 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 : | August 2002 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | May 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bacterial Infections
| Group/Cohort | Intervention/treatment |
|---|---|
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Levofloxacin-treated cohort
Participants receiveing levofloxacin in previous levofloxacin studies will be observed.
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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. |
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Comparator-treated cohort
Participants receiveing comparator in previous levofloxacin studies will be observed.
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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. |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 6 Months to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210639
Locations
Show 63 study locations
Sponsors and Collaborators
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. |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00210639 |
| 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. ) |
| First Posted: | September 21, 2005 Key Record Dates |
| Results First Posted: | May 23, 2011 |
| Last Update Posted: | April 21, 2014 |
| Last Verified: | April 2014 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
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Musculoskeletal Diseases Musculoskeletal Disorders Childhood Disease Bone Diseases |
Joint Diseases Levofloxacin Quinolones Bacterial infections |
Additional relevant MeSH terms:
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Bacterial Infections Musculoskeletal Diseases Bacterial Infections and Mycoses Infections |