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

This study is currently recruiting participants.
Verified February 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01945281
First received: September 13, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Candidiasis, Invasive
Drug: Caspofungin
Drug: Amphotericin B Deoxycholate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants with Fungal-free Survival Through the 2-week Posttherapy Period [ Time Frame: Up to 104 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants with Fungal-free Survival Through the End of Study Treatment [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofungin
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
Drug: Caspofungin
Active Comparator: Amphotericin B Deoxycholate
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
Drug: Amphotericin B Deoxycholate

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945281

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, New York
Call for Information (Investigational Site 0061) Recruiting
Rochester, New York, United States, 14642
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01945281     History of Changes
Other Study ID Numbers: 0991-064
Study First Received: September 13, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Amphotericin B
Liposomal amphotericin B
Amphotericin B, deoxycholate drug combination
Caspofungin
Echinocandins
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 22, 2014