Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)

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

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief 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 post-therapy follow-up visit.

Overall Status Terminated
Start Date 2014-01-15
Completion Date 2018-02-28
Primary Completion Date 2018-01-02
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period Up to 104 days
Secondary Outcome
Measure Time Frame
Percentage of Participants With Fungal-free Survival Through the End of Study Treatment Up to 90 days
Number of Participants With an Adverse Event (AE) 8 weeks after end of study therapy (up to 146 days)
Enrollment 51
Condition
Intervention

Intervention Type: Drug

Intervention Name: Caspofungin

Arm Group Label: Caspofungin

Intervention Type: Drug

Intervention Name: Amphotericin B Deoxycholate

Arm Group Label: Amphotericin B Deoxycholate

Eligibility

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

Gender: All

Minimum Age: N/A

Maximum Age: 3 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Merck Sharp & Dohme Corp.
Verification Date

2019-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Caspofungin

Type: Experimental

Description: Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

Label: Amphotericin B Deoxycholate

Type: Active Comparator

Description: Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov

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