E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Community acquired pneumonia |
|
E.1.1.1 | Medical condition in easily understood language |
Community acquired pneumonia |
|
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 | 10010120 |
E.1.2 | Term | Community acquired pneumonia |
E.1.2 | System Organ Class | 100000004862 |
|
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 assess the steady state pharmacokinetics of telithromycin oral suspension (25 mg/kg once a day for 7-10 days), in children 6 months to less than 13 years of age (<13) with community acquired pneumonia (CAP).
|
|
E.2.2 | Secondary objectives of the trial |
To assess the safety of telithromycin oral suspension (25 mg/kg once a day for 7 to 10 days) relative to azithromycin oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5 [40 mg/mL], not to exceed 500 mg on Day 1 and 250 mg/day from Day 2 to 5) in the safety population. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects meeting all of the following criteria will be considered for enrollment into the study:
• Children, male and female, 6 months to less than 13 years of age (<13). Females must be premenarchal (ie, without childbearing potential);
• Clinical signs and symptoms, including at least 2 of the following:
− Fever (within the previous 24 hours);
Temperature >38°C (100.4°F) rectal, or >37°C (98.6°F) oral, or >37.5°C (99.5°F) tympanic.
− Dyspnea or tachypnea, which is progressive in nature;
− Cough;
− Elevated white blood cell (WBC) count >15000/μL;
− Pulmonary consolidation on physical examination (eg, rales on auscultation, dullness to percussion, egophony).
• Chest X-ray, within 48 hours prior to inclusion, confirmed by a qualified physician as showing evidence of a pulmonary infiltrate compatible with acute bacterial, Mycoplasma pneumoniae, or, Chlamydophila (Chlamydia) pneumoniae infection;
Informed consent must be obtained in writing at enrollment into the study, from the child’s parent/legally authorized representative. |
|
E.4 | Principal exclusion criteria |
• Known underlying pulmonary malformation or diseases (eg, bronchial obstruction, cystic fibrosis, active tuberculosis, Pneumocystis jiroveci (carinii) pneumonia, pneumonia of suspected viral origin);
• Complications related to pneumonia such as empyema, lung abscess, extrapulmonary extension (eg, meningitis, endocarditis, arthritis);
• Requires use of systemic antibiotic therapy other than study medication or hospitalization;
• Known severe immunodeficiency (eg, acquired immunodeficiency syndrome with <25% CD4 or requiring prophylaxis for P. jiroveci (carinii) or treatment for an opportunistic infection, chronic use of oral corticosteroids, cancer, or hematological malignancy);
• Hospitalization or residence in a long-term care facility for 14 or more days prior to the onset of symptoms;
• Females of childbearing potential (ie, those that have reached menarche);
• The subject:
− Is being treated with drugs not permitted by the study protocol: cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin, atorvastatin, or probenecid;
− Has been treated with rifampicin, phenytoin, carbamazepine, or St. John’s wort within the last 2 weeks;
− Is currently being treated with parenteral antibiotics or has been treated with systemic antibiotics within 7 days prior to enrollment; or
− Has been treated with any investigational medication in the last 30 days prior to enrollment.
• Known congenital prolongation of the QTc interval;
• Known or suspected uncorrected hypokalemia (potassium ≤3mmol/ L [mEq/L]),
hypomagnesemia (based on laboratory assessment), or bradycardia (<50 beats per minute);
• Myasthenia gravis;
• Known impaired renal function, as shown by creatinine clearance of ≤25 mL/min (see the equation for calculation of creatinine clearance,
Any medical condition (including developmental disorders, visual disorders, or ocular abnormalities) that, in the opinion of the investigator, would interfere with implementation of the protocol or interpretation of the study results;
• 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics parameters : Telithromycin plasma concentration |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
(Day 6-10) End of treatment |
|
E.5.2 | Secondary end point(s) |
- safety measurements (vital signs, laboratory values, and AEs reported)
- number of patients with adverse events of special interest
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Study duration
- Up to (Day 17-24) Posttherapy
|
|
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 | No |
E.6.6 | Pharmacokinetic | Yes |
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 |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial days | 24 |