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

This study has been terminated.
(Pediatric development program terminated by sponsor)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174811
First received: September 13, 2005
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Otitis Media
Drug: telithromycin (HMR3647)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).

Secondary Outcome Measures:
  • 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.

Enrollment: 639
Study Start Date: June 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174811

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
France
Sanofi- Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174811     History of Changes
Other Study ID Numbers: EFC6131, HMR3647B/3001
Study First Received: September 13, 2005
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
acute otitis media
controlled clinical trial
telithromycin
cefuroxime axetil
middle ear infections
tympanocentecis

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Telithromycin
Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014