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临床试验/PER-004-98
PER-004-98已完成未知

A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of MK-0991 Vs. Fluconazole for the Treatment of Esophageal Candidiasis in Adults

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 1999年3月26日最近更新:
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试验速览

阶段
未知
状态
已完成
发起方
研究概览入排标准研究者记录与标识符相似试验

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
0 至 0（—）

入选标准

  • •a. Patients with a diagnosis of esophageal candidiasis for whom I.V. therapy is appropriate. Esophagoscopy start grade must be >1 (Clinical Response, grading System of Disease). In all cases, the disease must be documented by 1) symptoms consistent with esophageal candidiasis, 2) photographic documentation by esophagoscopy, and 3) positive stain of brushing from esophagoscopy followed by either a positive culture for Candida spp. or a positive histopathologic evidence of Candida infection.
  • •b. Patients on antifungal therapy at the time of screening must have all antifungal therapies stopped at least 48 hours prior to the start of treatment.
  • •c. The patient is an adult between the ages of 18 and 80. Women of childbearing potential are eligible for inclusion only after the risk-benefit potential has been determined with their physician.
  • •d. Women of childbearing potential must have a negative serum or urine pregnancy test sensitive to 25lU HCG prior to enrollment into the study and subsequently use adequate birth control measures as defined by the investigator. Oral contraceptives should not be used as the sole method of birth control because the effect of MK-0991 on the efficacy of oral contraceptives has not yet been established.
  • •e. A prestudy chest X-ray must be obtained and must not demonstrate any active pulmonary disease.

排除标准

  • •-Failure to meet all inclusion criteria.
  • •-Abnormal laboratory values:
  • •1) Hemoglobin <8g/dL.
  • •2) Platelet count<75,000/mL (<25,000/mL for neutropenic patients [ANC<500/mL]).
  • •3) Creatinine clearance <50 mL/min.
  • •4) INR >1.6 or PT greater than control. If the patient is on an anticoagulant, patients with an INR >3.0 will be excluded.
  • •5) Total serum bilirubin >1.5X upper limit of normal (ULN). Patients with hyperbilirubinemia, which is primarily indirect and which is not from primary liver dysfunction, may enroll if the direct bilirubin is <2X ULN.
  • •6) AST (SGOT) or ALT (SGPT) >5X ULN.
  • •7) Alkaline phosphatase >3X ULN.
  • •-History of allergy, hypersensitivity, or any serious reaction to echinocandin antifungals, fluconazole, or other azoles.
  • •-Patients with esophageal candidiasis who were treated in the 30 days prior to screening with more than one dose of the following antifungals: 1) fluconazole >100mg/day, 2) ketoconazole >200mg/day, or 3) itraconazole >100 mg/day
  • •-Patients who are undergoing acute therapy for another active opportunistic infection. Patients who are clinically stable on maintenance therapy are not excluded. Patients must receive standard of care therapy for opportunistic infections (acute and continuous).
  • •-Patients who are not expected to survive at least 2 months.
  • •-Patients with another cause of esophagitis (i.e., CMV, HSV, bacterial, gastroesophageal-reflux, pill-related) or who have clearly defined ulcers on esophagoscopy in which the likelihood of another pathogen is high.
  • •-Patients who have other esophageal pathology (e.g., stenosis, mass lesions) on esophagoscopy which is unrelated to acute esophageal candidiasis.
  • •-Women who are pregnant or breast-feeding.
  • •-Any patient with a diagnosis of acute hepatitis or cirrhosis due to any cause. Patients who are HBsAg-positive or hepatitis C positive may enroll into the study if their LFTs meet the specified criteria.
  • •-Participation in any other clinical study involving the administration of an investigational drug within 14 days of screening, or during the course of the study.
  • •-Prior treatment with an echinocandin or previous participation in an MK-0991 study at any time.
  • •-Patient has any condition or concomitant illness, which, in the opinion of the investigator, might confuse the results of the study or pose additional risk in administering the study drugs to the patient.
  • •-Patients who are taking, rifampin, ritonavir, tacrolimus (FK-506), cyclosporine A, terfenadine, cisapride, or astemizole.
  • •-Patients who have any contraindication to fluconazole.

研究者

发起方
MERCK SHARP & DOHME PERU S.R.L.,

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