E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | PT |
E.1.2 | Classification code | 10049140 |
E.1.2 | Term | Pharyngotonsillitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
Primary objective of this study was to compare the bacteriologic efficacy of 5 days of telithromycin to 10 days of penicillin V in subjects with baseline bacterial throat culture positive for Streptococcus pyogenes and repeat throat culture performed at the posttherapy/test-of-cure visit (Visit 3, Days 13 to 17) (per-protocol population for bacteriologic outcome [PPb]).
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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 months to less than 13 years of age with the following inclusion criteria participated:
• clinical diagnosis of acute tonsillitis/pharyngitis caused by S. pyogenes based on positive result from a rapid detection
throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture,
identification, and antibiotic-susceptibility testing
• sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:
tonsil and/or pharyngeal erythema and/or exudate, cervical adenopathy, uvular edema, and fever.
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E.4 | Principal exclusion criteria |
•Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough);
•History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P;
•Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis);
•History of rheumatic heart disease;
•Females of childbearing potential (ie, have reached menarche);
•Known congenital prolonged QT syndrome;
•Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm);
•Myasthenia gravis;
•Known impaired renal function, as shown by creatinine clearance ≤25 mL/min
•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 and atorvastatin;
◦Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days;
◦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;
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E.5 End points |
E.5.1 | Primary end point(s) |
• Percentage of patients according to bacteriological outcome in PPb 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 bacteriological outcome in mITT b population
• Percentage of patients according to bacteriological outcome in PPb population at late posttherapy
• 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)
• At late posttherapy (Day 38-45)
• 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 | Yes |
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 | 5 |