EUCTR2016-001246-26-BG进行中（未招募）1 期
A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults - Phase II CABP trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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 = 18 years of age
- •2. Willing to participate in the study and provide written informed consent before any protocol specific assessment is performed
- •3. Meet the following clinical criteria for CABP:
- •a. Have at least TWO of the following symptoms (new or worsening):
- •Dyspnea (shortness of breath)
- •Production of purulent sputum
- •Pleuritic chest pain
- •b. Have at least TWO of the following vital sign abnormalities:
- •Fever or hypothermia documented by the Investigator (oral, rectal, or tympanic temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
- •Hypotension, defined as systolic blood pressure < 90 mm Hg
- •Tachycardia, defined as heart rate > 90 beats per minute
- •Tachypnea, defined as respiratory rate > 20 breaths per minute
- •c. Have at least ONE of the following laboratory abnormalities:
- •Hypoxemia defined as arterial oxygen saturation < 90% by pulse oximetry or PaO2 < 60 mm Hg by ABG
- •Auscultatory findings on pulmonary examination consistent with bacterial pneumonia or pulmonary consolidation (e.g., rales, dullness on percussion, bronchial breath sounds, or egophony)
- •Elevated total WBC count (> 10,000 cells/mm3) or leucopenia (WBC <4,000 cells/mm3)
- •Elevated immature neutrophils (> 15% band forms), regardless of total peripheral WBC count
- •d. Radiographic evidence of CABP:
- •Radiographically-confirmed pneumonia, i.e., new or progressive
- •pulmonary infiltrate(s) on CXR or CT scan consistent with acute bacterial pneumonia within 48 h prior to randomization
- •e. PORT score of 51 to 105 (PORT Risk Class of II, III or IV) (Appendix II)
- •4. All females must have a negative urine or serum pregnancy test (ß-HCG) at Screening AND agree to the use of one of the following acceptable methods of contraception from Screening through TOC: surgical sterilization (defined as bilateral oophorectomy or bilateral salpingectomy, but excluding bilateral tubal occlusion), post-menopausal (defined by amenorrhea for at least 12 months
- •following cessation of all exogenous hormonal treatments), barrier contraception (e.g., condom, intrauterine device), levonorgestrel intrauterine system (e.g., Mirena®), regular medroxyprogesterone injections (e.g., Depo-Provera®), sexual intercourse with only vasectomised partners, or abstinence. Note that oral
- •contraceptives should not be used as the sole method of birth control because the effect of nafithromycin on the efficacy of oral contraceptives has not yet been established; subjects who take oral contraceptives must also use one of the acceptable forms of birth control (listed above) from Screening through TOC.
- •Males must agree to use an acceptable barrier method of birth control (i.e., condom) with female partner(s) and must not donate sperm from Screening through TOC.
- •5. Ability to ingest oral study drug (e.g., able to swallow large capsules intact, and no significant nausea, vomiting, diarrhea, or any other condition that might impair ingestion or absorption of oral study drug)
- •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 203
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Subjects with any of the following confirmed or suspected types of pneumonia:
- •Aspiration pneumonia
- •HABP, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h hospitalization in an acute in-subject health care facility.
- •HCAP, defined as pneumonia acquired in a long-term care or subacute healthcare facility or pneumonia with onset after recent hospital discharge (within 90 days of current admission and previously hospitalized for = 48 h)
- •VABP, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h endotracheal intubation
- •Pneumonia that may be caused by pathogen(s) resistant to either study drug (nafithromycin or moxifloxacin), including viral, mycobacterial, or fungal pneumonia
- •Post-obstructive pneumonia
- •Pneumonia associated with cystic fibrosis
- •2. Suspected or confirmed pleural empyema (a parapneumonic pleural effusion is not an exclusion criterion) or lung abscess
- •3. Suspected or confirmed non-infectious causes of pulmonary infiltrates
- •4. Receipt of 1 or more dose(s) of a potentially-effective systemic antibacterial treatment for treatment of the current CABP within 72 h prior to randomization with the exception of:
- •Receipt of a single dose of a short-acting antibacterial agent within 72 h of randomization OR
- •Failure (worsening of symptoms) of at least 48 h of treatment for the current episode of CABP with an antibacterial agent other than a ketolide or fluoroquinolone
- •5. Subjects requiring concomitant adjunctive or additional potentially effective systemic antibacterial treatment for management of CABP
- •6. Evidence of significant immunologic disease determined by any of the following:
- •Current or anticipated neutropenia defined as < 500 neutrophils/mm3
- •Known infection with HIV (prior to Screening) and a CD4 count that is unknown or documented to be < 200 cells/mm3 within the last year, or an AIDS-defining illness; note that neither HIV nor CD4 testing is required at Screening
- •History of heart, lung, or kidney transplant
- •The receipt of cancer chemotherapy, radiotherapy, or potent, noncorticosteroid immunosuppressant drugs (e.g., cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy) within the past 3 months, or the receipt of corticosteroids equivalent to or greater than 40 mg of prednisone per day for more than 14 days in the 30 days prior to randomization
- •7. Known or suspected primary or metastatic neoplastic lung disease, bronchiectasis, bronchial obstruction, chronic neurological disorder preventing clearance of pulmonary secretions, or severe COPD (severe COPD is defined as known [prior to Screening] FEV1/FVC < 0.70 and FEV1 < 50% normal); note that pulmonary function tests are not required at Screening
- •8. Compromised hepatic or renal function, including but not limited to: clinical evidence of end-stage liver disease (e.g., ascites, hepatic encephalopathy), screening serum total bilirubin > 2 times ULN (unless associated with an elevated indirect bilirubin typical of Gilbert syndrome), AST or ALT > 3 times ULN, serum creatinine > 2.0 mg/dl and/or BUN > 30 mg/dl. Other clinically-significant
- •abnormal laboratory findings should be discussed with the Medical Monitor prior to the subject's entry.
- •9. History of Clostridium difficile-associated disease within 6 months prior to enrolment
- •10. History of hypersensitivity, known contraindication (e.g. lactose intolerance,lactase deficiency and glucose
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