Clinical trial NCT00315003: TELI COM - Telithromycin in Children With Otitis Media
Official title: Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Otitis Media, Suppurative
Otitis Media, Purulent
Keywords: Otitis Media
Suppurative
Purulent
Ketolide
Azithromycin
Telithromycin
Controlled Clinical Trials
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.
Secondary outcomes:
measure: Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis
city: Laval
country: Canada
facility: Sanofi-Aventis
city: Providencia
country: Chile
facility: Sanofi-Aventis
state: Santiago
city: Santafe de Bogota
country: Colombia
facility: Sanofi-Aventis
city: San José
country: Costa Rica
facility: Sanofi-Aventis
city: Praha
country: Czech Republic
facility: Sanofi-Aventis
city: Santo-Domingo
country: Dominican Republic
facility: Sanofi-Aventis
city: Guatemala
country: Guatemala
facility: Sanofi-Aventis
city: Israel
country: Israel
facility: Sanofi-Aventis
city: Panama
country: Panama
facility: Sanofi-Aventis
city: Lima
country: Peru
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: