NCT00548080

Brief Summary

Registration study

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

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

March 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

October 19, 2007

Last Update Submit

December 16, 2015

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (1)

  • The proportion of caspofungin-treated patients with SAE

Secondary Outcomes (1)

  • The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

Interventions

MK0991, caspofungin acetate / Duration of Treatment:DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has had an absolute neutrophil count \< 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever \>38.0 Degrees Centigrade within the last 24 hours prior to study entry
  • Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage

You may not qualify if:

  • Patient has an inadequately managed bacterial infection at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycoses

Interventions

CaspofunginDuration of Therapy

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 23, 2007

Study Start

March 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 17, 2015

Record last verified: 2015-12