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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Candidiasis, Invasive

Treatments: Drug: Amphotericin B Deoxycholate; Drug: Caspofungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01945281

2013-002084-26 (EudraCT Number)

MK-0991-064 (Other Identifier)

0991-064

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Caspofungin

Experimental group

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

Treatment:

Drug: Caspofungin

Amphotericin B Deoxycholate

Active Comparator group

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

Treatment:

Drug: Amphotericin B Deoxycholate