EUCTR2004-001609-89-AT进行中（未招募）不适用
A Multicenter, Randomized, Open-Label Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Intravenous Imipenem in Ventilator-Associated Pneumonia - DORI-10
Peninsula Pharmaceuticals, Inc0 个研究点目标入组 400 人开始时间: 2005年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1.Males or females > 18 years old being treated in an ICU.
- •2.Patient hospitalized for = 48 hours or has prior hospital admission of at least 48 hours and was discharged within the last 7 days. Non-ambulatory residents of chronic care facilities admitted with pneumonia are also eligible.
- •3.Patient has received mechanical ventilation for > 24 hours or has weaned from mechanical ventilation within 72 hours.
- •4.CPIS > 5.
- •5.Presence of a new or progressive infiltrate on chest x-ray.
- •6.At least 1 of the following:
- •a.Fever, defined as an oral temperature > 38° C (100.4° F) or a rectal/core temperature > 39° C (102.2° F) or hypothermia, defined as a rectal/core body temperature of < 35° C (95.2° F)
- •b.Elevated total peripheral WBC count (= 10,000/mm3) or > 15% immature forms (bands) regardless of total peripheral WBC count; or leukopenia with total peripheral WBC < 4,500/mm3 (caused by the infection)
- •7.Infection is known or presumed at time of enrollment to be caused by microorganisms susceptible to both study drugs. The addition of vancomycin is allowed for suspected or confirmed MRSA or Enterococcus infection. Patients can be enrolled before culture results are known.
- •8.Females of childbearing potential must have a negative serum pregnancy test (ß human chorionic gonadotropin [ß-hCG]) prior to enrollment in the study and, subsequently, for at least 1 month after study treatment must agree to use adequate birth control measures. Hormonal contraceptives are not to be used as the sole method of birth control.
- •9.Patient requires IV antibacterial therapy.
- •10.Patient is able to provide informed consent. If the patient is unable, the patient’s legally acceptable representative may provide written consent as approved by institutional specific guidelines.
- •11.Microbiologic Inclusion Criteria: All patients who meet the clinical and radiographic criteria for VAP, must have an acceptable specimen of respiratory tract secretions taken prior to inclusion and randomization into this study. However, patients can be enrolled in this study before the results of the culture are known. The specimen should be obtained by endotracheal aspiration or bronchoscopy, if scheduled for clinical reasons, either by BAL or protected-specimen brush. Specimens obtained within 24 hours prior to enrollment are acceptable if no antibiotic therapy is given since the time that specimen was obtained.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must NOT meet any of the following exclusion criteria:
- •1.Known at study entry to have VAP caused by pathogen(s) resistant to either imipenem or meropenem (other than MRSA or Enterococcus, which can be treated with vancomycin).
- •2.APACHE II score <8 or >25.
- •3.Considered unlikely to survive to the LFU visit, 28 -35 days after completion of study therapy.
- •4.Patients with an order of no cardiopulmonary resuscitation in case of cardiac arrest.
- •5.Presence of a concomitant extrapulmonary infection that requires non-study systemic antibacterial therapy or prolonged (> 14 days) antimicrobial treatment.
- •6.Presence of structural lung disease, emphysema, or ARDS (eg diffuse radiographic infiltrates and Pa02 to FiO2 ratio < 200).
- •7.Presence of cavitary lung disease based on chest x-ray findings, primary lung cancer or another malignancy metastatic to the lungs, cystic fibrosis, or known or suspected Pneumocystis carinii pneumonia.
- •8.Any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure or septic shock.
- •9.Use of systemic antibiotic therapy (with activity against the likely causative respiratory pathogens) for = 24 hours within 72 hours prior to randomization unless the patient is a clinical failure for VAP or has a new infiltrate that developed while the patient was taking the prior antibiotic regimen.
- •10.The need for concomitant systemic antimicrobial agents (other than vancomycin or amikacin) or Xigris® (drotregogin alpha) in addition to study drug(s).
- •11.End stage renal impairment requiring peritoneal dialysis, hemodialysis or hemofiltration.
- •12.The presence of hepatic disease:
- •i. ALT or AST > 4 x ULN; values up to 6 x ULN are allowed if acute and, if in the opinion of the investigator, directly related to the infectious process being treated.
- •ii. Bilirubin > 2 x ULN, unless isolated hyperbilirubinemia is directly related to the acute process.
- •iii. Alkaline phosphatase > 4 x ULN. Patients with values up to 5 x ULN are eligible if this value is historically stable.
- •13.Hematocrit < 20%.
- •14.Neutropenia with absolute neutrophil count < 500 cells/mm3.
- •15.Platelet count < 40,000/mm3.
- •16.Coagulation tests > 1.5 x ULN (PT, PTT, or INR). Patients on anticoagulants with values > 1.5 x ULN can be enrolled, provided these values are stable and within the therapeutic range.
- •17.Immunocompromising illness including known infection with human immunodeficiency virus (HIV), AIDS, hematological malignancy, and bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, and the administration of corticosteroids equivalent to or greater than 10 mg of prednisone per day administered for more than 14 days.
- •18.Women who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control (e.g., condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence).
- •19.History of moderate or severe hypersensitivity reactions to carbapenems, penicillins, other beta-lactam antibiotics, or ß-lactamase inhibitors.
- •20.Participation in any investigational drug or device study within 30 days prior to study entry.
- •21.Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
- •22.Patients who previously received more than 1 dose of a carbapenem for the curr
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