Acute otitis media in children. MedDRA version: 7 Level: 2 Classification code 10021881
Conditions
Interventions
Product Name: Telithromycin 10% powder for oral suspension
Product Code: HMR3647B
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: telithromycin
Current Sponsor code: HMR3647B
Conc
Sponsors
Aventis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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; •Tympanometry exhibiting the following results: -Type B curve or positive pressure peak curves consistent with the presence of MEF; •Otalgia or ear tugging or touching within the last 24H 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; •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. Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria
Exclusion criteria: •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); •Myasthenia gravis; •Known impaired renal function, as shown by the creatinine clearance =25 mL/min •Any medical condition (including development disorders, visual disroders, or ocular anormalities) 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 or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the noninferiority of telithromycin with respect to cefuroxime axetil in clinical efficacy at the posttherapy/test-of-cure visit 3 (Days 13–17) in the per protocol population for analysis of clinical outcome (PPc population) in children with acute otitis media (AOM).;Secondary Objective: •To assess time to symptom resolution in the mITT and PPc populations. •To assess clinical efficacy by protocol-defined causative pathogen isolated at baseline at the on-therapy, posttherapy/TOC, and late posttherapy visits in the bacteriologically evaluable populationS (bmITT and PPb) •To assess clinical efficacy in the overall bacteriologically evaluable (PPb, bmITT) populations at the on-therapy, posttherapy/TOC, and late posttherapy visits. •To assess microbiologic outcomes by protocol-defined pathogens isolated at baseline at the on-therapy, posttherapy/TOC, and late posttherapy visits. •To assess the overall safety of telithromycin versus cefuroxime axetil •To assess the prevalence of nasopharyngeal carriage of S. pneumoniae •To characterize plasma telithromycin concentrations in a subset of subjects •To assess health resource utilization, and impact on usual activities of parents/legally authorized representatives.;Primary end point(s): The primary efficacy variable is the clinical efficacy at the posttherapy/TOC visit 3 (Day 13-17) in the PPc population. | — |
Countries
Germany
Outcome results
None listed