NCT00174811

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
639

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

September 13, 2005

Last Update Submit

April 2, 2009

Conditions

Otitis Media

Keywords

acute otitis mediacontrolled clinical trialtelithromycincefuroxime axetilmiddle ear infectionstympanocentecis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Interventions

telithromycin (HMR3647)DRUG

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi- Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Otitis Media

Interventions

telithromycin

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

US(1)FR(1)