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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

Page last updated: August 20, 2015

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