Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Invasive
Intervention: Caspofungin (Drug); Amphotericin B Deoxycholate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Sharp & Dohme Corp. Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared
with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and
infants. The primary hypothesis to be tested in the study is that caspofungin will be
superior to amphotericin B deoxycholate with regard to the proportion of participants with
fungal-free survival at the 2-week posttherapy follow-up visit.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants Less Than 3 Months of Age
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants with Fungal-free Survival Through the 2-week Posttherapy Period
Secondary outcome: Percentage of Participants with Fungal-free Survival Through the End of Study Treatment
Eligibility
Minimum age: N/A.
Maximum age: 3 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Culture-confirmed invasive Candida infection
Exclusion Criteria:
- Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial
skin surfaces
- Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip,
or previously placed indwelling non-vascular catheters or drains
- Prosthetic device as the suspected site of Candida infection
- Active co-infection with a non-Candida fungal organism
- Received >48 hours of systemic antifungal treatment since the positive Candida index
culture was collected as therapy for the present episode of invasive candidiasis
- Failed prior systemic antifungal therapy for the present episode of invasive
candidiasis
- Diagnosis of acute hepatitis or cirrhosis
- Scheduled or anticipated to receive rifampin or other systemic antifungal therapy
while on study therapy
- History (including participant's mother) of allergy, hypersensitivity, or any serious
reaction to caspofungin or other member of the echinocandin class, or to amphotericin
B deoxycholate or other member of the polyene class
- Severe congenital disorder known to lower immune response
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
MSD Brasil, Sao Paulo, Brazil; Recruiting
Ricardo Germano, Phone: 55 11 51897942
MDS Colombia SAS, Bogota, Colombia; Recruiting
Francesca Carvajal, Phone: 57 1219109011090
MSD, Mexico City, Mexico; Recruiting
Juan Marques, Phone: 52 55254819608
Merck Sharp & Dohme Romania SRL, Bucharest, Romania; Recruiting
Simona Olaru, Phone: 38 (044) 393 74 80
MSD (Pty) LTD South Africa, Midrand, South Africa; Recruiting
Khanyi Mzolo, Phone: 27 11 655 3140
Merck Sharp & Dohme Ilaclari Ltd. Sti, Istanbul, Turkey; Recruiting
Alev Eren, Phone: 90 212 336 12 63
Call for Information (Investigational Site 0071), Los Angeles, California 90095, United States; Recruiting
Call for Information (Investigational Site 0061), Rochester, New York 14642, United States; Recruiting
Additional Information
Starting date: January 2014
Last updated: August 7, 2015
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