Otitis MediaPhase 3NCT00174811
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
A Phase 3 study testing telithromycin (HMR3647) in people with Otitis Media, run by Sanofi at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Otitis Media
- What is being tested?
- telithromycin (HMR3647)
- How many people
- 639 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2005to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media
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.
- Conditions
- Otitis Media
- Being tested
- telithromycin (HMR3647)
- Keywords
- acute otitis media, controlled clinical trial, telithromycin, cefuroxime axetil, middle ear infections, tympanocentecis
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telithromycin (HMR3647)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Health resource utilization and impact on usual activities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: Pediatric development program terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174811
- Sponsor's protocol ID
- EFC6131
- Other IDs
- HMR3647B/3001
- Status last verified
- Apr 2009
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media
- ClinicalTrials.gov ID
- NCT00174811
- Acronym / sponsor ID
- EFC6131
- Conditions
- Otitis Media
- Keywords
- acute otitis media, controlled clinical trial, telithromycin, cefuroxime axetil, middle ear infections, tympanocentecis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pediatric development program terminated by sponsor
- Enrolment
- 639 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telithromycin (HMR3647) | Drug | – |
Primary outcome
Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).
6 secondary outcomes
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.
Health resource utilization and impact on usual activities.
Results and safety
The study was stopped early (reason given: Pediatric development program terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telithromycin (HMR3647) in people with Otitis Media, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pediatric development program terminated by sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2009.