NCT01318148

Brief Summary

The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

2.4 years

First QC Date

March 17, 2011

Last Update Submit

January 8, 2014

Conditions

Fungal Infection

Keywords

EchinocandinsCaspofunginPharmacokineticsProphylaxisAntifungalAspergillosisAcute Leucemia

Outcome Measures

Primary Outcomes (1)

  • caspofungin pharmacokinetic

    To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population.

    day 20 (average), till end of enutropenia

Secondary Outcomes (3)

  • Caspofungin pharmacokinetic

    day 20 (average), at end of neutropenia

  • Incidence of invasive fungal disease and outcome

    day 100 after start of chemotherapy

  • Safety of intermittent caspofungin

    day 34 (average), 2 weeks after end of neutropenia

Study Arms (1)

Caspofungin

EXPERIMENTAL
Drug: caspofungin

Interventions

caspofunginDRUG

Intermittent intravenous application of caspofungin

Also known as: Cancidas
Caspofungin

Eligibility Criteria

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

You may qualify if:

  • acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
  • receiving induction chemotherapy

You may not qualify if:

  • current or need of systemic antifungal therapy
  • history of proven or probable invasive aspergillus infection
  • pregnant or breastfeeding women
  • weight more than 100 kg
  • history of allergy, hypersensitivity or any serious reaction to caspofungin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wuerzburg Medical Centre, Department of Internal Medicine II

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

MycosesAspergillosis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Werner J Heinz, MD

    University of Wuerzburg Medical Centre, Department of Internal Medicine II

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Infectious Diseases

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

DE(1)