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

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ClinicalTrials.gov Identifier: NCT01945281
Recruitment Status : Terminated (Operational feasibility with low recruitment due to changing epidemiology of disease)
First Posted : September 18, 2013
Results First Posted : August 28, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 13, 2013
First Posted Date  ICMJE September 18, 2013
Results First Submitted Date  ICMJE July 30, 2018
Results First Posted Date  ICMJE August 28, 2018
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE January 15, 2014
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period [ Time Frame: Up to 104 days ]
Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Percentage of Participants with Fungal-free Survival Through the 2-week Posttherapy Period [ Time Frame: Up to 104 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • Percentage of Participants With Fungal-free Survival Through the End of Study Treatment [ Time Frame: Up to 90 days ]
    Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
  • Number of Participants With an Adverse Event (AE) [ Time Frame: 8 weeks after end of study therapy (up to 146 days) ]
    An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Percentage of Participants With Fungal-free Survival Through the End of Study Treatment [ Time Frame: Up to 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Candidiasis, Invasive
Intervention  ICMJE
  • Drug: Caspofungin
  • Drug: Amphotericin B Deoxycholate
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Amphotericin B Deoxycholate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
51
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
90
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Brazil,   Colombia,   Mexico,   Romania,   South Africa,   Turkey,   United States
 
Administrative Information
NCT Number  ICMJE NCT01945281
Other Study ID Numbers  ICMJE 0991-064
2013-002084-26 ( EudraCT Number )
MK-0991-064 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP