---
title: TELI COM - Telithromycin in Children With Otitis Media
nct_id: NCT00315003
overall_status: TERMINATED
phase: PHASE3
sponsor: Sanofi
study_type: INTERVENTIONAL
primary_condition: Otitis Media, Suppurative
countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Czechia, Dominican Republic, Guatemala, Israel, Panama, Peru
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00315003.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00315003"
ct_last_update_post_date: 2009-04-03
last_seen_at: "2026-05-12T06:16:09.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00315003](https://clinicaltrials.gov/study/NCT00315003)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Pediatric development program terminated by sponsor
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1500
- **Lead Sponsor:** Sanofi
- **Conditions:** Otitis Media, Suppurative, Otitis Media, Purulent
- **Start Date:** 2006-01
- **Completion Date:** 2006-07
- **CT.gov Last Update:** 2009-04-03

## 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

- **Minimum age:** 6 Months
- **Maximum age:** 6 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Interventions

- **Telithromycin** (DRUG)
- **Azithromycin** (DRUG)

## Primary Outcomes

- **The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.**

## Secondary Outcomes

- **Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.**

## Locations (13)

- Sanofi-Aventis, Bridgewater, New Jersey, United States
- Sanofi-Aventis, Buenos Aires, Argentina
- Sanofi-Aventis, São Paulo, Brazil
- Sanofi-Aventis, Laval, Canada
- Sanofi-Aventis, Providencia, Santiago Metropolitan, Chile
- Sanofi-Aventis, Bogotá, Colombia
- Sanofi-Aventis, San José, Costa Rica
- Sanofi-Aventis, Prague, Czechia
- Sanofi-Aventis, Santo Domingo, Dominican Republic
- Sanofi-Aventis, Guatemala City, Guatemala
- Sanofi-Aventis, Israel, Israel
- Sanofi-Aventis, Panama City, Panama
- Sanofi-Aventis, Lima, Peru

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sanofi-aventis|bridgewater|new jersey|united states` — added _(2026-05-12)_
- `locations.sanofi-aventis|buenos aires||argentina` — added _(2026-05-12)_
- `locations.sanofi-aventis|são paulo||brazil` — added _(2026-05-12)_
- `locations.sanofi-aventis|laval||canada` — added _(2026-05-12)_
- `locations.sanofi-aventis|providencia|santiago metropolitan|chile` — added _(2026-05-12)_
- `locations.sanofi-aventis|bogotá||colombia` — added _(2026-05-12)_
- `locations.sanofi-aventis|san josé||costa rica` — added _(2026-05-12)_
- `locations.sanofi-aventis|prague||czechia` — added _(2026-05-12)_
- `locations.sanofi-aventis|santo domingo||dominican republic` — added _(2026-05-12)_
- `locations.sanofi-aventis|guatemala city||guatemala` — added _(2026-05-12)_
- `locations.sanofi-aventis|israel||israel` — added _(2026-05-12)_
- `locations.sanofi-aventis|panama city||panama` — added _(2026-05-12)_
- `locations.sanofi-aventis|lima||peru` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00315003.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00315003*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*