None listed
Conditions
Interventions
Group 1 Type of group
- Subjects of less than or equal to 24 months of age will receive: Telithromycin 2000 mg once daily and Cefuroxime axetil placebo 2500 mg twice daily for 10 days
- All other subjects will receive: Telithromycin 2000 mg once a day for 5 days (Days 1 to 5), Telithromycin placebo once per day for 5 days (Days 6 to 10) and Cefuroxime axetil placebo twice a day for 10 days
Group name:Group 2 Type of group
Telithromycin Placebo once daily for 10 days and Cefuroxime axetil placebo 2500 mg twice daily for 10 days
Sponsors
AVENTIS PHARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects greater than or equal to 6 months and <59 months of age with AOM. 2) A sudden and recent attack with signs and symptoms of AOM. 3) The presence of LOM in the otoscopy indicated by a protruding tympanic membrane. 4) A tympanometry that presents the following results: A type B curve or positive pressure peak curves consistent with the presence of LOM. 5) Otalgia or that the patient is pulling or touching the ear in the last 24 hours, that interfere with, or avoid normal activities or sleep. 6) At least one of the following non-specific clinical findings for AOM: fever, vomiting, diarrhea, anorexia, sleep disturbances, or irritability. 7) Tympanocentesis executed according to the protocol. 8) Written informed consent must be obtained at the time of recruitment.
Exclusion criteria
Exclusion criteria: 1) An unclear diagnosis of AOM. 2) Otorrea or tube of tympanostosmia present in any of the ears upon entering the study. 3) Otitis extema. 4) Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis / mucoviscidosis, immobile cilia syndrome, congenital imminence or acquired immunodeficiency syndrome with a <25% CD4 count or requiring prophylaxis for Pneumocystis Jiroveci. 5) Known congenital prolonged QT syndrome. 6) Uncorrected hypokalemia, hypomagnesemia, bradycardia. 7) Myasthenia gravis. 8) Known impaired renal function. 9) Any medical condition that, in the opinion of the investigator, could interfere with the implementation of the protocol or with the interpretation of the results of the study. 10) The subject: a) Is being treated with drugs not allowed by the protocol b) Is currently being treated with sistemic antibacterials or has been treated with systemic antibacterials in the 5 days prior to recruitment c) Has been treated with research drugs inside of the previous 30 days. d) Has been treated with rifampicin, phenytoin, carbamazepine, or St. John´s wort in the last 2 weeks. 11) History of hypersensitivity or intolerance to macrolides, penicillins or cephalosporins 12) Previous recruitment in this study or previous treatment with telithromycin. 13) Children of researcher or sub-investigator, research assistant, pharmacist, study coordinator, or other staff members, or relatives of the people involved in the conduct of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Efficacy of treatment Timepoints:Days 13-17 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Symptom resolution time: Clinical evaluation. Clinical efficacy and microbiological sensitivity: tympanostomy cultures Measure:Symptom resolution time. Clinical efficacy and microbiological sensitivity. Timepoints:Symptom resolution time: Days 13-17. Tympanostomy cultures: Visit in therapy (Days 5-7), PDC post-therapy visit (Days 13-17) and Post-therapy visit (Days 24-28). ; Outcome name:Clinical evaluation for the detection of adverse effects. Patient report Measure:Safety of treatment Timepoints:Visit in therapy (Days 5-7), PDC post-therapy visit (Days 13-17) and Post-therapy visit (Days 24-28). ; Outcome name:Concentration of telithromycin in blood in 2 blood samples Measure:Pharmacokinetic information Timepoints:Visit 2 (Days 5-7) ; Outcome name:Case report: 1) Use of health sources (counting visits to the emergency room, hospitalization, clinic visits, telephone calls and e-mails), 2) Economic impact (lost days of work or activities, additional cost of the care of other children) Measure:Evaluate the results of utilization of health resources and the impact on usual activities of parents Timepoints:Days 13 to 17 | — |
Countries
France, Peru, United States
Outcome results
None listed