EUCTR2014-004039-37-ES进行中（未招募）1 期
A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 years of age, inclusive) and Children (? 2 months to <12 years of age) with Suspected or Confirmed Community-Acquired Bacterial Pneumonia.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •1. Written informed consent from parents or other legally acceptable representatives and informed assent from subject (if age appropriate according to local requirements)
- •2. ?2 months to 17 years of age, inclusive
- •3. Requiring hospitalization, emergency room, or urgent care visit
- •4. Presence of CABP based on the following criteria within 72 hours prior to randomization:
- •History of and/or documented fever (rectal, ear, or oral temperature ?38°C or axillary temperature ?37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)
- •Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
- •Presence of at least 2 of the following signs or symptoms:
- •b. Difficulty breathing
- •c. Production of purulent sputum
- •d. Chest pain
- •e. Grunting
- •f. Hypotension
- •g. Tachycardia, defined as follows:
- •· 2 months to <24 months: ?160 beats/min
- •· 24 months to <10 years: ?140 beats/min
- •· ?10 years: ?100 beats/min
- •h. Tachypnea, defined as follows:
- •· 2 months to <12 months: ?50 breaths/min
- •· 12 months to <5 years: ?40 breaths/min
- •· ?5 years: ?20 breaths/min
- •i. Physical exam consistent with pulmonary consolidation
- •Presence of at least 1 of the following:
- •a. Leukocytosis (?12,000 white blood cells [WBC]/mm3)
- •b. Leukopenia (<5000 WBC/mm3)
- •c. ?10% immature neutrophils (bands) regardless of total peripheral WBC
- •d. Elevated inflammatory markers (C-reactive protein or procalcitonin)
- •e. Oxygen saturation <97% on room air
- •f. Organism consistent with a typical respiratory pathogen identified from a blood culture or isolated from an appropriate respiratory culture/polymerase chain reaction (sputum in children old enough to produce an acceptable specimen; sample from the lower respiratory tract airways, if performed [e.g., bronchoalveolar lavage]; or pleural fluid culture)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •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
- •1. Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pathogens (e.g., ventilator-associated pneumonia; hospital-acquired pneumonia).
- •2. Received >48 hours of potentially effective systemic antibacterial therapy for CABP immediately prior to randomization (exception: clinical or microbiological treatment failure or progression of signs or symptoms of CABP as determined by the investigator).
- •3. Confirmed or suspected bacterial meningitis.
- •4. Known active pulmonary tuberculosis.
- •5. Non-infectious causes of pulmonary infiltrates (e.g., cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia).
- •6. Evidence or history of clinically significant medical condition that may, in the assessment of the investigator, impair study participation or pose a significant safety risk or diminish the subject's ability to undergo all study procedures and assessments.
- •7. Hepatic dysfunction evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times upper limit of normal (ULN) or direct bilirubin greater than 2 times ULN (If direct bilirubin values are not available in a timeframe consistent with enrolment requirements, total bilirubin must be <2 times ULN).
- •8. Treatment with the following drugs within 72 hours prior to first dose of study drug or expected to receive these drugs during the treatment phase: drugs that potently inhibit CYP3A4 (nefazodone, fluconazole, ketoconazole, conivaptan, diltiazem, verapamil, aprepitant, imatinib, protease inhibitors, clarithromycin, ciprofloxacin, erythromycin, itraconazole, mibefradil, posaconazole, telithromycin, and voriconazole); CYP3A4 inducers (rifampin, rifabutin, phenytoin, fosphenytoin, carbamazepine, phenobarbital, rufinamide, modafinil, armodafinil, etravirine, efavirenz, nevirapine, rilpivirine, bosentan, troglitazone, pioglitazone, and St. John's wort). In addition, the following drugs may not be
- •co-administered with solithromycin in this trial due to the potential for adverse drug-drug interaction: digoxin, colchicine, midazolam, quinidine, ergotamine, dihydroergotamine, cisapride, cyclosporine, sildenafil, astemizole, and alfentanil.
- •9. Breast-feeding females.
- •10. Positive pregnancy test in females of childbearing potential.
- •11. History of anaphylaxis to macrolide antibiotics.
- •12. Previous participation in this study.
- •13. Subject has received any investigational drug studied under an Investigational New Drug application in the U.S. or under a Clinical Trial Application in the relevant country outside of the U.S. where the subject is being enrolled, taken within 4 weeks before administration of the first dose of study drug.
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