PER-028-14未知未知
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
- 未知
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
- 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.
排除标准
- •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,
- •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 wi
研究者
相似试验
已完成
不适用
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY AND SAFETYOF CADAZOLID VERSUS VANCOMYCIN IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATEDDIARRHEA (CDAD)-A047 Enterocolitis due to Clostridium difficileEnterocolitis due to Clostridium difficileA047PER-087-13Actelion Pharmaceuticals Ltd,1
进行中（未招募）
不适用
RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF THE EFFICACY, TOLERABILITY AND SAFETY OF VALDECOXIB (BEXTRA®)10 MG OD VS. DICLOFENAC SODIUM 50 MG TDS FOR 6 WEEKS IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. - N/AOsteoarthritis of the kneeClassification code 10031161EUCTR2004-001713-34-GBPfizer Limited516
已完成
不适用
A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF 90 MG ETORICOXIB ONCE A DAY COMPARED WITH 75 MG SODIUM DICLOFENACO TWICE A DAY IN PATIENTS WITH RHEUMATOID ARTHRITIS.-M06M06PER-011-03MERCK & CO.INC.,
已完成
不适用
A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ETORICOXIB 90 MG PER DAY, VS. SODIC DICLOFENACO 50 MG THREE TIMES A DAY IN PATIENTS WITH OSTEOARTHRITIS.-M15M15PER-054-02MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFECT OF THE ADDITION OF MONTELUKAST SODIUM OR SALMETEROL XINAFOATE TO INHALED FLUTICASONE IN ASTHMATIC ADULTSPER-016-99MERCK SHARP & DOHME PERÚ S.R.L.,