EUCTR2015-002346-32-PL进行中（未招募）1 期
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Associated Diarrhea in Patients with a Diagnosis of a Lower Respiratory Tract Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 372
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. Male or female patients age =50 years
- •2. Informed consent (IC) obtained and signed prior to study participation
- •3. Expected minimum hospital stay of 5 days
- •4. Expected =5 day course of intravenous (IV) ceftriaxone alone or in combination with a
- •macrolide, e.g., clarithromycin or azithromycin
- •5. Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index
- •(PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended. Note: the PSI/PORT score inclusion requirement applies to all patients and can be obtained within 24 hours of signing informed consent..
- •6. Patients must agree to use an acceptable method of contraception from the time of signing the ICF to 24 hours after the final dose of study drug if the patient is a sexually active female of child bearing potential (defined as all females after puberty who are not postmenopausal for at least 1 year, or surgically sterile). Adequate contraceptive measures include: oral contraceptives (stable use for 2 or more cycles before Screening); intrauterine device; Depo Provera; Norplant System implants; bilateral tubal ligation; partner with a vasectomy; use of a condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence.
- •7. Patients must have a negative urine pregnancy test at Day 1 before dosing if a female patient of child bearing potential.
- •8. The patient is willing and able to comply with all testing and study requirements as defined in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 297
排除标准
- •1. Presence of a diarrheal illness within 72 hours prior to randomization
- •2. Current treatment for CDAD or ongoing active CDAD infection, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
- •3. Number of previous CDAD episodes >1 within 12 weeks prior to randomization or CDAD within 4 weeks prior to randomization
- •4. Use of antibiotics within 1 month of start of study drug except for the current illness. Note: Oral antibiotics for the current episode of lower respiratory tract infection within 72 h prior to the first dose of study drug are allowed
- •5. In the judgment of the investigator any factors (e.g., other treatment) that could invalidate the treatment result
- •6. Known intolerance of study drug/ingredients
- •7. Present or past diagnosis of inflammatory bowel disease such as Crohn's Disease or ulcerative colitis. Evidence of active GI infections e.g., parasitic infection, Salmonella, Shigella
- •8. Patients requiring tracheal intubatation and mechanical ventilation. Non-invasive ventilation including biphasic intermittent positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) are acceptable
- •9. Patients with bronchiectasis, cystic fibrosis, aspiration pneumonia, confirmed influenza, or chronic alcoholism
- •10. Neutrophil count <500 cells/mm3. Value should be obtained within 24 hours of informed consent
- •11. AST, ALT > 5x upper limit normal (ULN). Values should be obtained within 24 hours of informed consent
- •12. Active chemotherapy, receipt of organ transplant
- •13. Renal failure requiring dialysis
- •14. Patient is currently enrolled in another clinical study or has received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the ICF, whichever is longer
研究者
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