EUCTR2014-002867-13-Outside-EU/EEA进行中（未招募）不适用
Multinational, randomized, double blind, double dummy, pharmacokinetic study of telithromycin oral suspension (25 mg/kg once daily for 7-10 days), with secondary assessments of safety relative to azithromycin oral suspension (10 mg/kg once daily for 1 day followed by 5 mg/kg once daily for 4 days) in children with mild to moderate community-acquired pneumonia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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;
- •- 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
排除标准
- •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.
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