Status:
TERMINATED
TELI COM - Telithromycin in Children With Otitis Media
Lead Sponsor:
Sanofi
Conditions:
Otitis Media, Suppurative
Otitis Media, Purulent
Eligibility:
All Genders
6-6 years
Phase:
PHASE3
Brief Summary
This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with AOM.Subjects w...
Eligibility Criteria
Inclusion
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- Subjects ≥6 months and \<72 months (\< 6 years) of age;
- Recent (within the last 72 hours) and rapid onset of AOM symptoms and signs;
- 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;
- Caregiver-reported AOM symptoms sufficient for entry according to protocol criteria.
- Caregiver-reported AOM symptoms diary
- Tympanometry exhibiting:
- Type B curve or positive pressure peak curves.
Exclusion
- Subjects presenting with any of the following will not be included in the study:
- Uncertain diagnosis of AOM or mild to moderate symptoms and signs 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 the ear to be evaluated;
- 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 long QT syndrome;
- Known or suspected uncorrected hypokalemia (≤3 mmol/L \[mEq/L\]), hypomagnesemia, bradycardia (\<50 bpm);
- Myasthenia gravis;
- Known impaired renal function, as shown by creatinine clearance ≤25 mL/min;
- History of hypersensitivity or intolerance to macrolides or azithromycin;
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00315003
Start Date
January 1 2006
End Date
July 1 2006
Last Update
April 3 2009
Active Locations (13)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Buenos Aires, Argentina, 1642
3
Sanofi-Aventis
São Paulo, Brazil, 05677-000
4
Sanofi-Aventis
Laval, Canada