Clinical trial NCT01945281: Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Candidiasis, Invasive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 51
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period
timeFrame: Up to 104 days
Secondary outcomes:
measure: Percentage of Participants With Fungal-free Survival Through the End of Study Treatment
timeFrame: Up to 90 days
measure: Number of Participants With an Adverse Event (AE)
timeFrame: 8 weeks after end of study therapy (up to 146 days)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kim J, Nakwa FL, Araujo Motta F, Liu H, Dorr MB, Anderson LJ, Kartsonis N. A randomized, double-blind trial investigating the efficacy of caspofungin versus amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants younger than 3 months of age. J Antimicrob Chemother. 2020 Jan 1;75(1):215-220. doi: 10.1093/jac/dkz398.