TELI COM - Telithromycin in Children With Otitis Media
- Conditions
- Otitis Media, SuppurativeOtitis Media, PurulentMedDRA version: 17.1Level: LLTClassification code 10033092Term: Otitis media suppurativeSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004637-47-Outside-EU/EEA
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1500
Patients between 6 and 72 months of age with confirmed AOM and with the following inclusion criteria participated:
• Recent and rapid onset of AOM symptoms and signs
• Presence of middle ear fluid (MEF) on otoscopy
• Otalgia or ear tugging or touching
• At least 1 of the following clinical findings not specific to AOM: fever (>38°Celsius), vomiting, diarrhea, anorexia, sleep disturbance, or irritability
• Tympanometry exhibiting the following results: Type B curve or positive pressure peak curves
Are the trial subjects under 18? yes
Number of subjects for this age range: 1500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study was to assess the efficacy of telithromycin versus azithromycin in children with acute otitis media (AOM) with regard to superiority of time to symptom resolution in the modified intent-to-treat (mITT) population and noninferiority of clinical outcome at the test-of-cure visit (Days 13 to 17) in the per protocol (PPc) population.<br>;Secondary Objective: -;Primary end point(s): • Percentage of patients according to clinical outcome in PPc population<br>• Time to symptoms resolution in mITT population<br><br><br>;Timepoint(s) of evaluation of this end point: At posttherapy (Day 13-17) <br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Percentage of patients according to clinical outcome in mITT population<br>• Number of patients with adverse events of special interest<br><br>;Timepoint(s) of evaluation of this end point: • At posttherapy (Day 13-17)<br>• Up to 7 days after end of treatment <br><br><br>