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. (see Contacts and Locations)
Verified August 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: August 13, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
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: August 13, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014