PER-030-99已完成未知
A PROSPECTIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, COMPARATIVE STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF MK-0826 VERSUS CEFEPIME IN THE TREATMENT OFHOSPITAL-ACQUIRED PNEUMONIA IN ADULTS
MERCK SHARP & DOHME PERÚ S.R.L.,0 个研究点目标入组 0 人开始时间: 1999年4月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •A.Clinical and Radiographic Findings
- •The patient has a clinical picture of a new onset of hospital-acquired bacterial pneumonia >48 hours after hospitalization or admission to another skilled-care facility or onset within 3 days of discharge from either type of facility. In addition, at least two of the following should be present:
- •1.Cough, new or worsened,
- •2.New onset of the production of purulent sputum or other respiratory secretions or a change in the character of sputum for microbiological criteria definitions of adequate sputum Gram stain findings
- •3.Auscultatory findings on chest examination of rales and/or signs of pulmonary consolidation
- •4.Dyspnea, tachypnea (respiratory rate >20/minute), or pleuritic chest pain, particularly if any or all of these are progressive in nature,
- •5.Hypoxemia (e.g., PO2 <60 mm Hg or Sa02 <90%), while the patient is breathing room air.
- •In addition, at least one of the following clinical findings should be met:
- •1.Fever, OR hypothermia,
- •2.An elevated total peripheral white blood cell count (WBC >10,000/uL),>15% immature neutrophils (bands) regardless of total peripheral white count, or leukopenia with a total WBC <4500/uL (if caused by the infection).
- •B.Microbiologic Criteria:
- •1.At enrollment all patients should have a respiratory secretion specimen collected and sent to the laboratory for Gram´s stain and culture.
- •2.Microscopic examination of Gram-stained respiratory secretions (10 to 20 oil fields) should show <10 squamous epithelial cells and >25 polymorphonuclear cells per field at 100X magnification.
- •3.Two sets of blood cultures (both aerobic and anaerobic) from 2 different sites in all patients should be obtained prior to initiation of study drug.
- •4.Antimicrobial susceptibility testing should be performed on all pathogens isolated from respiratory tract infections.
- •C.≥18 Years (Males and Females are Eligible)
- •D.Females of childbearing potential must have a negative serum pregnancy test (B-HCG) prior to enrollment into the study. They must subsequently use adequate birth control measures for 1 month after the completion of study therapy as discussed with the investigator.
- •E.Patient´s infection is known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the intravenous study antibiotics.
- •F.Patient´s infection has been treated with <24 hours of systemic antibiotic therapy.
- •G.If there is any suspicion of an outbreak of nosocomial Legionella infection at the study site, then a urine test for Legionella antigen must be performed and have negative results. If the results are not available until after enrollment, then patients with a positive Legionella antigen test may need to be withdrawn from study therapy.
排除标准
- •A.Pneumonia acquired in an intensive care unit.
- •B.Pneumonia acquired while the patient is on mechanical ventilation.
- •C.Any patient who has received:
- •1.Broad-spectrum antibiotic therapy (effective against gram-negative and gram-positive bacteria) for >5 days in the 10 days prior to onset of pneumonia.
- •2.>24 hours of any systemic antibiotic therapy effective for the treatment of pneumonia in the last 72 hours unless the patient is a failure of the prior regimen.
- •D.Patients who are likely to require ventilator support for their pneumonia within 24 hours of onset.
- •E.Patients from whom Pseudomonas is isolated in an adequate prestudy sputum specimen.
- •F.History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any adverse reaction to carbapenem antibiotics (such as imipenem), cefepime, or any penicillins, p-lactams, cephalosporins, or metronidazole. Patients with a history of mild (nonurticarial) rash to penicillins or other p-lactams may be enrolled.
- •G.Pregnant women, nursing women, or fertile women who are not, in the judgment of the investigator.
- •H.Patients with a rapidly progressive or terminal illness, patients in whom a response to antibiotic therapy is considered unlikely, or patients who are considered unlikely to survive the study period.
- •I.Patients with empyema.
- •J.The need for concomitant systemic antibacterial agents in addition to the study antibiotics.
- •K.Concurrent infection that would interfere with evaluation of response to the study antibiotic.
- •L.Patients who are malnourished.
- •M.Patients with cystic fibrosis, bronchiectasis, AIDS, known or suspected Pneumocystis carínii pneumonia, known or suspected active tuberculosis, or who are on therapy for tuberculosis.
- •N.Patients with known bronchial obstruction or a history of postobstructive pneumonia. (Patients with chronic obstructive pulmonary disease [COPD] are eligible).
- •O.Patients with primary lung cancer or another malignancy metastatic to the lungs.
- •P.Patients who are receiving immunosuppressive therapy including the use of corticosteroids (>10 mg prednisone daily or equivalent) as chronic therapy.
- •Q.Hematocrit <25%; or Hemoglobin <8 g/dL (<80 g/L IU).
- •R.Neutropenia with absolute neutrophil count (ANC) <1000 cells/uL. Patients with ANCs as low as 500 cells/uL may be permitted if this reduction is due to the acute infectious process.
- •S.Platelet count <75,000/uL; patients with platelet counts as low as 50,000/uL will be permitted if this reduction is historically stable.
- •T.Patients requiring peritoneal dialysis, hemodialysis, or hemofiltration.
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