EUCTR2013-003453-13-ES进行中（未招募）不适用
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial 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
- 860
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 and female patients >=18 years of age.
- •2. An acute onset of at least 3 of the following signs and symptoms (new or worsening):
- •b. Production of purulent sputum
- •c. Shortness of breath (dyspnea)
- •d. Chest pain due to pneumonia
- •3. At least 1 of the following:
- •a. Fever: (defined as body temperature >38°C [100.4°F] measured orally, >38.5°C [101.3°F] measured tympanically, or >39°C [102.2°F] measured rectally)
- •b. Hypothermia: (defined as body temperature <35°C [95.0°F] measured orally, <35.5°C [95.9°F] measured tympanically, or <36°C [96.8°F] measured rectally)
- •c. Presence of pulmonary rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
- •4. The patient will have received no systemic antibiotics other than a single dose of a short-acting antibiotic (penicillins, cephalosporins [not ceftriaxone], tetracyclines, or trimethoprimsulfamethoxazole) in the 7 days prior to enrollment.
- •5. PORT Risk Class II, III or IV (pneumonia severity scores of 51 to 130, inclusive).
- •6. In the opinion of the Investigator, intravenous therapy is both warranted and feasible.
- •7. Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study (e.g. chest radiograph [CXR] [posteroanterior and lateral preferred; single view acceptable if conclusive] or computed tomography [CT] of thorax) within 48 hours before the first dose of study drug. The Investigator may interpret the imaging study to qualify a patient for enrollment; however, the imaging study must also be interpreted by a local radiologist.
- •8. Females of non-childbearing potential: surgically sterile (e.g. tubal ligation) or at least 2 years postmenopausal
- •9. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study and for 30 days after the last dose of study drug.
- •10. Males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) while participating in the study and for 30 days after the last dose of study drug, or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal.
- •11. The patient has voluntarily signed and dated the Investigational Review Board/Independent Ethics Committee (IRB/IEC) approved ICF prior to any study-specific screening procedures.
- •12. The patient must be able to attend all study visits and comply with all study procedures.
- •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 688
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 172
排除标准
- •Exclusion Criteria:
- •1. Ventilator-associated pneumonia.
- •2. Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe COPD defined as forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <70% and FEV1 <50% predicted. Note: Patients with less severe COPD are not excluded. Patients with COPD without a documented FEV1/FVC or FEV1 may be enrolled if in the Investigator?s opinion the COPD is not severe.
- •3. Presence of known:
- •a. Viral or fungal pneumonia
- •b. Pneumocystis jiroveci pneumonia
- •c. Aspiration pneumonia
- •d. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
- •e. Primary or metastatic lung cancer
- •f. Cystic fibrosis
- •g. Active or suspected tuberculosis
- •h. Empyema (not including sterile parapneumonic effusions).
- •4. Presence of pneumonia known to be caused by a pathogen resistant to moxifloxacin or solithromycin.
- •5. Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms (i.e. healthcare-associated pneumonia).
- •6. Any condition that could affect drug absorption, e.g. status post gastrectomy.
- •7. History of post-antibiotic colitis within the last 3 months.
- •8. Mean QTcF (QT interval corrected with the Fridericia formula) greater than 450 msec on screening summary (or triplicate) electrocardiogram (ECG).
- •9. Concomitant use of drugs known to prolong the QT interval, including class Ia (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmics.
- •10. Concomitant use of drugs, foods, or herbal products known to be moderate to potent inhibitors of CYP3A4 isozymes: oral antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole); human immunodeficiency virus (HIV) protease inhibitors (e.g. ritonavir and saquinavir), hepatitis C virus (HCV) protease inhibitors (e.g. boceprevir and telaprevir), nefazodone, fluvoxamine, conivaptan, diltiazem, verapamil, aprepitant, ticlopidine, crizotinib, imatinib; grapefruit or grapefruit juice.
- •11. Any use within the prior 7 days of drugs or herbal products known to be moderate to potent inducers of CYP3A4 isozymes: St. John?s Wort, rifampin, rifabutin, anti-convulsants (e.g. phenobarbital, carbamazepine, phenytoin, rufinamide), modafinil, armodafinil, etraverine, efavirenz, bosentan.
- •12. Required current use of drugs with narrow therapeutic indices that are principally metabolized by CYP3A4 or transported by P-glycoprotein (P-gp), for which a drug interaction with solithromycin could result in higher and possibly unsafe exposures to these drugs: e.g. the P-gp substrates digoxin or colchicine and the CYP3A4 substrates alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, midazolam, pimozide, quinidine, sirolimus, tacrolimus, everolimus, and terfenadine.
- •13. Receiving or anticipated to receive a daily dose of ?20 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrollment. Note: Patients are allowed to receive an acute, short course of methylprednisolone or prednisone (or equivalent) for management of an acute exacerbation of COPD or reactive airway disease in asthmatics.
- •14. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
- •15. Known history of significant and ongoing renal, hepatic, or hematologic impairment. Current treatment for HCV infection.
- •16. Any of the follo
研究者
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