.A.
- Registration Number
- PER-004-98
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients with both resolution of symptoms and either resolution of endoscopic lesions, or a reduction of endoscopic lesions by at least two grades after therapy.<br>Measure:Primary effectiveness criteria<br>Timepoints:5-7 days after last dose.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The proportion of patients who develop one or more drug-related adverse events.<br>Measure:Primary safety criteria<br>Timepoints:Throughout the study.<br>;<br>Outcome name:The proportion of patients who discontinue due to a drug-related adverse event.<br>Measure:Secondary safety criteria<br>Timepoints:Throughout the study.<br>;<br>Outcome name:Proportion of patients with a favourable symptomatic response.<br>Measure:Secondary effectiveness criteria<br>Timepoints:5-7 days after last dose.<br>;<br>Outcome name:The proportion of patients with relapse of esophagitis symptoms after intravenous antifungal therapy.<br>Measure:Secondary effectiveness criteria<br>Timepoints:28 days after last dose.<br>