Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

NCT ID: NCT00082524

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-07-31

Brief Summary

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This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).

Detailed Description

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Conditions

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Aspergillosis Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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caspofungin acetate

Duration of Treatment - 7-90 days

Intervention Type DRUG

Other Intervention Names

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MK0991

Eligibility Criteria

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Inclusion Criteria

* Children, 3 months through 17 years of age,
* with esophageal candidiasis or
* invasive candidiasis or
* children requiring salvage treatment of invasive aspergillosis.
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. doi: 10.1542/peds.2008-1158.

Reference Type BACKGROUND
PMID: 19255017 (View on PubMed)

Study Documents

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Document Type: CSRSynopsis

View Document

Other Identifiers

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Formerly-0404CCAI

Identifier Type: -

Identifier Source: secondary_id

MK0991-043

Identifier Type: -

Identifier Source: secondary_id

2004_100

Identifier Type: -

Identifier Source: secondary_id

0991-043

Identifier Type: -

Identifier Source: org_study_id

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