- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638859
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Evaluation of the Safety, Pharmacokinetics, Efficacy, and Acceptability of HMR3647 20 mg/kg qd for 5-7 Days With Community-Acquired Pneumonia (CAP) in Children (Multicenter, Open Label, Noncomparative Study)
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP).
Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tokyo, Japan
- Sanofi-Aventis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
- Subjects who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
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Secondary Outcome Measures
Outcome Measure |
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Clinical efficacy: change in the symptoms and signs
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Acceptability: compliance and willingness to take medication
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Pharmacokinetics: plasma concentrations of telithromycin
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: CSD, Sanofi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC6369
- HMR3647B/3101
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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