E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Otitis Media, Suppurative
Otitis Media, Purulent
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E.1.1.1 | Medical condition in easily understood language |
Otitis Media, Suppurative
Otitis Media, Purulent
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033092 |
E.1.2 | Term | Otitis media suppurative |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The primary objective of this study was to assess the efficacy of telithromycin versus azithromycin in children with acute otitis media (AOM) with regard to superiority of time to symptom resolution in the modified intent-to-treat (mITT) population and noninferiority of clinical outcome at the test-of-cure visit (Days 13 to 17) in the per protocol (PPc) population.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients between 6 and 72 months of age with confirmed AOM and with the following inclusion criteria participated:
• Recent and rapid onset of AOM symptoms and signs
• Presence of middle ear fluid (MEF) on otoscopy
• Otalgia or ear tugging or touching
• At least 1 of the following clinical findings not specific to AOM: fever (>38°Celsius), vomiting, diarrhea, anorexia, sleep disturbance, or irritability
• Tympanometry exhibiting the following results: Type B curve or positive pressure peak curves
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E.4 | Principal exclusion criteria |
•Uncertain diagnosis of AOM or mild to moderate symptoms and signs 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 the ear to be evaluated;
•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 long QT syndrome;
•Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), hypomagnesemia, bradycardia (<50 bpm);
•Myasthenia gravis;
•Known impaired renal function, as shown by creatinine clearance ≤25 mL/min;
•History of hypersensitivity or intolerance to macrolides or azithromycin;
•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) |
• Percentage of patients according to clinical outcome in PPc population
• Time to symptoms resolution in mITT population
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At posttherapy (Day 13-17)
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E.5.2 | Secondary end point(s) |
• Percentage of patients according to clinical outcome in mITT population
• Number of patients with adverse events of special interest
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• At posttherapy (Day 13-17)
• Up to 7 days after end of treatment
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |