E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute otitis media in children. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7 |
E.1.2 | Level | 2 |
E.1.2 | Classification code | 10021881 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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). |
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E.2.2 | Secondary objectives of the trial |
•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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The duration of this study is expected to be 18 months, with subject recruitment proposed to start in the fourth quarter of 2004 and end in January 2006 The study will be closed once all data inquiries sent to the sites have been responded to. This is estimated to be 60 days after the last subject’s last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |