NCT00330395

Brief Summary

The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

May 24, 2006

Last Update Submit

February 20, 2017

Conditions

Candidiasis

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters of drug exposure

Secondary Outcomes (1)

  • Safety and tolerability

Interventions

caspofungin acetateDRUG

Duration of Treatment 28 Days

Also known as: MK0991

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates and infants \<3 months of age
  • Patient has a body weight greater than or equal to 500 grams
  • Patient has documented or highly suspected Candida infection

You may not qualify if:

  • Patient is greater than 3 months of age
  • Patient has a body weight of less than 500 grams
  • Patient does not meet certain laboratory testing criteria
  • Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
  • Patient has documented HIV infection of any stage
  • Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.

    PMID: 19075070BACKGROUND

MeSH Terms

Conditions

Candidiasis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 24, 2006

First Posted

May 26, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02