A Phase 3 interventional study of Telithromycin and Azithromycin in Otitis Media, Suppurative and Otitis Media, Purulent, sponsored by Sanofi. Terminated at 13 sites in 13 countries. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2009-04-03.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 1,500 is above the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Tympanometry exhibiting:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.
Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.
The record gives a start of Jan 2006, a primary completion of Jul 2006 and a completion of Jul 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Telithromycin · Azithromycin