NCT00333645

Brief Summary

This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group \[EORTC/MSG\] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2003

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
unknown

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

October 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 13, 2007

Status Verified

December 1, 2006

First QC Date

June 4, 2006

Last Update Submit

April 12, 2007

Conditions

Liver TransplantationFungal Infection

Keywords

Liver transplantationInvasive fungal infectionInvasive aspergillosisProphylaxisCaspofungin

Outcome Measures

Primary Outcomes (1)

  • Absence of breakthrough proven/probable invasive fungal infection by day +100

Secondary Outcomes (4)

  • Absence of breakthrough proven/probable invasive aspergillosis by day +100

  • Discontinuation of study therapy due to a drug-related adverse event

  • Incidence of drug-related serious adverse event(s)

  • Incidence of drug-related adverse event(s)

Interventions

CaspofunginDRUG

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Patient has received an orthotopic liver transplantation
  • Patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation
  • For women of childbearing potential, patient must have a negative serum or urine pregnancy test

You may not qualify if:

  • Any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug.
  • Documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment.
  • Abnormal laboratory values as defined per protocol.
  • Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal.
  • Patient not expected to survive at least 5 days.
  • Patient is pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Complejo Hospitalario Juan Canalejo

A Coruña, E-15006, Spain

RECRUITING

Hospital de Cruces

Barakaldo, E-48903, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, E-08035, Spain

RECRUITING

Complejo Hospitalario Reina Sofia

Córdoba, E-14004, Spain

WITHDRAWN

Hospital Universitario Virgen de las Nieves

Granada, E-18014, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, E-28007, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, E-28034, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, E-28035, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, E-28041, Spain

RECRUITING

Complejo Hospitalario Carlos Haya

Málaga, E-29010, Spain

RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, E-15706, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, E-41013, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, E-46009, Spain

RECRUITING

Related Publications (1)

  • Fortun J, Muñoz P, Cisneros JM, et al. Antifungal prophylaxis with caspofungin in high-risk liver transplant recipients: a noncomparative, open-label prospective clinical trial. Clinical Microbiology & Infection 12 (suppl. 4): P684, 2006. [Abstract on an interim analysis performed on the first 15 patients enrolled in the study, presented as a poster at 2006 ECCMID meeting].

    RESULT

MeSH Terms

Conditions

MycosesInvasive Fungal Infections

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Jesus Fortun, MD

    Hospital Ramon y Cajal, Madrid, Spain

    STUDY DIRECTOR

Central Study Contacts

Jesus Fortun, MD, PhD

CONTACT

+34-670-537460fortun@mi.madritel.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2006

First Posted

June 6, 2006

Study Start

October 1, 2003

Study Completion

March 1, 2007

Last Updated

April 13, 2007

Record last verified: 2006-12

Locations

ES(13)