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

NCT01945281 | Terminated Phase 2 Results DMC

• 3 other identifiers: 0991-0642013-002084-26MK-0991-064
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Candidiasis, Invasive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period

  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.

  Up to 104 days

Secondary Outcomes (2)

• Percentage of Participants With Fungal-free Survival Through the End of Study Treatment

  Up to 90 days

• Number of Participants With an Adverse Event (AE)

  8 weeks after end of study therapy (up to 146 days)

Study Arms (2)

Caspofungin

EXPERIMENTAL

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

Amphotericin B Deoxycholate

ACTIVE COMPARATOR

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

Interventions

Caspofungin DRUG

Caspofungin

Amphotericin B Deoxycholate DRUG

Amphotericin B Deoxycholate

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Culture-confirmed invasive Candida infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 31586424 RESULT

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Caspofungin; amphotericin B, deoxycholate drug combination

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Limitations and Caveats

The trial was terminated early due to operational feasibility with low recruitment due to changing epidemiology of disease.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: January 15, 2014
• Primary Completion: January 2, 2018
• Study Completion: February 28, 2018
• Last Updated: November 25, 2019
• Results First Posted: August 28, 2018

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share