Non-Blood Invasive Candidiasis
Conditions
Interventions
Trade Name: CANCIDAS
Product Name: Caspofungin for Injection
Product Code: MK-0991
Pharmaceutical Form: Injection*
Sponsors
Merck Sharp & Dohme BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within the 4 days prior to study entry. 2. The patient must also have clinical evidence of Candida infection, including at least one of the following within the 4 days prior to study entry: a. Oral temperature > 37.8ºC on 2 occasions at least 4 hours apart, or 1 temperature determination > 38.3ºC , or clinically significant hypothermia =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces. 2. The patient has Candida disease limited to the bloodstream. 3. The patient has evidence of infection limited to a positive culture for Candida spp. from sputum, broncho-alveolar lavage, catheter tip, or indwelling catheters/drains. 4. The patient has evidence of infection limited to a positive culture for Candida spp. from the urine without signs and symptoms of upper tract disease. 5. The patient has a prosthetic device at a suspected site of Candida infection. (NOTE: patients may be eligible for enrolment if the device is surgically removed at study entry or within 72 hours after randomization). 6. The patient has the following abnormal laboratory values: a. INR >1.6 (if patients receiving anticoagulation INR >4.0) b. Serum total bilirubin >5 times the upper limit of normal. c. Serum AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal. d. Serum Alkaline Phosphatase >5 times the upper limit of normal 7. The patient has a history of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class. 8. The patient has received caspofungin or another member of the echinocandin class at any time during the 7 days prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate in caspofungin-treated patients with non-blood sites of invasive candidiasis the favourable overall response rate (both clinical and microbiological) at the end of caspofungin therapy.;Secondary Objective: To estimate in caspofungin-treated patients with non-blood sites of invasive candidiasis, a) The favourable overall response rate (both clinical and microbiological) on day 10 of caspofungin therapy. b) The favourable overall response rate (both clinical and microbiological) at the end of all antifungal therapy (caspofungin and/or subsequent oral fluconazole). c) The occurrence of relapse during the 12 week follow-up period following the completion of all antifungal therapy in those patients successfully treated with caspofungin. ;Primary end point(s): The primary endpoint will be to display the proportion of caspofungin-treated patients with a favourable overall clinical response and favourable overall microbiological response at the end of caspofungin therapy. | — |
Countries
Belgium
Outcome results
None listed