- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174811
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
April 2, 2009 updated by: Sanofi
Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media
The clinical activity of telithromycin vs. cefuroxime in children with acute infections of the middle ear, ages 6 months to 59 months old will be studied.
Study Overview
Study Type
Interventional
Enrollment (Actual)
639
Phase
- Phase 3
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
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Paris, France
- Sanofi- Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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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 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects ≥6 months and <59 months of age with AOM;
- Recent (within the last 72 hours) and rapid onset of AOM signs and symptoms;
- The presence of MEF on otoscopy indicated by a bulging tympanic membrane;
- Otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep;
- At least 1 of the following clinical findings not specific to AOM: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability;
- Tympanocentesis performed per protocol with MEF sample collected;
- Informed consent must be obtained in writing at enrollment into the study, from the child's parent/legally authorized representative. The parent/legally authorized representative has agreed to provide follow-up information and arrange for all scheduled visits, even in the event that study medication is discontinued.
Exclusion Criteria:
- Uncertain diagnosis of AOM or signs and symptoms of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days;
- Otorrhea or tympanostomy tube present in either ear at study entry;
- Otitis externa;
- Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with <25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection;
- Known congenital prolonged QT syndrome;
- Uncorrected hypokalemia (≤3 mmol/L [mEq/L]), hypomagnesemia (based on laboratory assessment), bradycardia (<50 bpm);
- Myasthenia gravis;
- Known impaired renal function, as shown by the creatinine clearance ≤25 mL/min;
- Any medical condition (including developmental disorders, visual disorders, or ocular abnormalities) that, in the opinion of the investigator, would interfere with implementation of the protocol or interpretation of the study results;
- The subject:
- Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin;
- Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 5 days prior to enrollment;
- Has been treated with any investigational medication within the last 30 days; or
- Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.
- History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins;
- Previous enrollment in this study or previous treatment with telithromycin;
- Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).
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Secondary Outcome Measures
Outcome Measure |
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Time to symptom resolution (TSR).
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Clinical cure by protocol-defined causative pathogen isolated at baseline·
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Bacteriological eradication in population with protocol-defined causative pathogen isolated at baseline.
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Safety of telithromycin versus cefuroxime axetil.
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Plasma telithromycin concentrations during treatment in the subpopulation of subjects participating in the pharmacokinetic (PK) substudy.
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Health resource utilization and impact on usual activities.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 3, 2009
Last Update Submitted That Met QC Criteria
April 2, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC6131
- HMR3647B/3001
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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