NCT00148148

Brief Summary

The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Typical duration for phase_2

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

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2007

First QC Date

September 6, 2005

Last Update Submit

January 9, 2008

Conditions

Hematopoietic Stem Cell TransplantationFungus Diseases

Keywords

Hematopoietic Stem Cell TransplantationCaspofunginLiposomal Amphotericin B

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin with liposomal amphotericin B in accordance with NCI-CTC toxicity

Secondary Outcomes (3)

  • Pharmacokinetics and recording of the dose-intensity of caspofungin and liposomal amphotericin B in the setting of allogeneic stem cell transplantation

  • Examination of pharmacokinetical interactions between caspofungin and liposomal amphotericin B

  • Recording of the efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin and liposomal amphotericin B in the case of empirical antimycotic therapy

Interventions

caspofunginDRUG
liposomal amphotericin BDRUG

Eligibility Criteria

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

You may qualify if:

  • Adults (\> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes \[ANC\]: \< or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
  • Patients with persistent or recurrent fever (oral temperature \> or = 38.0°C) and granulocytopenia (absolute neutrophil count \< or = 500/µL) and adequate antibacterial therapy for \> or = 36-48 hours, who need empirical antimycotic therapy
  • Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
  • Sufficient renal and hepatic function
  • Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
  • Availability of written informed consent from the patient or respectively from the legal representative after prior information

You may not qualify if:

  • Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
  • Pregnant or nursing patients
  • Patients with pathological functional renal or hepatic parameters
  • Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
  • Hemodynamically unstable patients with a life expectancy of less than 5 days
  • Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
  • Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
  • Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKS Münster University Hospital

Münster, North Rhine-Westphalia, 48145, Germany

Location

MeSH Terms

Conditions

Mycoses

Interventions

Caspofunginliposomal amphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Andreas Groll, M.D.

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

May 1, 2004

Study Completion

December 1, 2007

Last Updated

January 16, 2008

Record last verified: 2007-01

Locations

DE(1)