A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)

NCT01165320 | Completed Phase 2 Results

• 2 other identifiers: 0991-074132240
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.

Conditions

Candidiasis, Esophageal; Candidiasis, Invasive; Aspergillosis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Overall Favorable Response to Therapy

  Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.

  Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days

• Percentage of Participants With One or More Drug-Related Adverse Experiences

  An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.

  Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days

Study Arms (3)

Participants with Esophageal Candidiasis

EXPERIMENTAL

Candida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.

Drug: Caspofungin

Participants with Invasive Candidiasis

EXPERIMENTAL

Candida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.

Drug: Caspofungin

Participants with Aspergillosis

EXPERIMENTAL

Aspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.

Drug: Caspofungin

Interventions

Caspofungin DRUG

Also known as: MK-0991, CANCIDAS®

Participants with Aspergillosis; Participants with Esophageal Candidiasis; Participants with Invasive Candidiasis

Eligibility Criteria

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

You may qualify if:

• Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.

You may not qualify if:

• Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
• Patients who will receive other systemic antifungal agents for the first time in screening period

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Mori M, Imaizumi M, Ishiwada N, Kaneko T, Goto H, Kato K, Hara J, Kosaka Y, Koike K, Kawamoto H, Maeda N, Yoshinari T, Kishino H, Takahashi K, Kawahara S, Kartsonis NA, Komada Y. Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis. J Infect Chemother. 2015 Jun;21(6):421-6. doi: 10.1016/j.jiac.2015.01.009. Epub 2015 Jan 30.

  PMID: 25701307 RESULT

MeSH Terms

Conditions

Candidiasis; Candidiasis, Invasive; Aspergillosis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 19, 2010
• Study Start: July 6, 2010
• Primary Completion: September 17, 2013
• Study Completion: September 17, 2013
• Last Updated: August 27, 2018
• Results First Posted: April 23, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share