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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

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ClinicalTrials.gov Identifier: NCT00174811
Recruitment Status : Terminated (Pediatric development program terminated by sponsor)
First Posted : September 15, 2005
Last Update Posted : April 3, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date April 3, 2009
Study Start Date  ICMJE June 2005
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
  • Time to symptom resolution (TSR).
  • Clinical cure by protocol-defined causative pathogen isolated at baseline·
  • Bacteriological eradication in population with protocol-defined causative pathogen isolated at baseline.
  • Safety of telithromycin versus cefuroxime axetil.
  • Plasma telithromycin concentrations during treatment in the subpopulation of subjects participating in the pharmacokinetic (PK) substudy.
  • Health resource utilization and impact on usual activities.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • - Time to symptom resolution (TSR).
  • - Clinical cure by protocol-defined causative pathogen isolated at baseline·
  • - Bacteriological eradication in population with protocol-defined causative pathogen isolated at baseline.
  • - Safety of telithromycin versus cefuroxime axetil.
  • - Plasma telithromycin concentrations during treatment in the subpopulation of subjects participating in the pharmacokinetic (PK) substudy.
  • - Health resource utilization and impact on usual activities.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Otitis Media
Intervention  ICMJE Drug: telithromycin (HMR3647)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2009)
639
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
900
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174811
Other Study ID Numbers  ICMJE EFC6131
HMR3647B/3001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP