TELI CAP - Telithromycin in children with mild to moderate community-acquired pneumonia

Conditions: Community acquired pneumonia
MedDRA version: 17.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-002867-13-Outside-EU/EEA

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 210

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 210
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: <br>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).<br>;Secondary Objective: 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.;Primary end point(s): Pharmacokinetics parameters : Telithromycin plasma concentration;Timepoint(s) of evaluation of this end point: (Day 6-10) End of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - safety measurements (vital signs, laboratory values, and AEs reported)<br>- number of patients with adverse events of special interest<br>;Timepoint(s) of evaluation of this end point: - Study duration<br>- Up to (Day 17-24) Posttherapy<br>