CClinicalTrials.gg
Status unknownNCT00333645Updated Apr 13, 2007

Prophylaxis With Caspofungin in High-Risk Liver Transplantation

A Phase 2 interventional study of Caspofungin in Liver Transplantation and Fungal Infection, sponsored by Grupo de Estudio de Infecciones en Transplantados. Status unknown at 13 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-13.

Sponsored by Grupo de Estudio de Infecciones en Transplantados · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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%.

02

Conditions studied

  • Liver Transplantation
  • Fungal Infection

Keywords

  • Liver transplantation
  • Invasive fungal infection
  • Invasive aspergillosis
  • Prophylaxis
  • Caspofungin
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 70 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Grupo de Estudio de Infecciones en Transplantados as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants

Interventions

  • DrugCaspofungin
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

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

  3. Incidence of drug-related serious adverse event(s)

  4. Incidence of drug-related adverse event(s)

07

Study locations

12 of 13 sites recruiting
  • Hospital de Cruces
    Barakaldo, E-48903, Spain
    • Miguel Montejo, MD · Principal investigator
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, E-08035, Spain
    • Joan Gavaldà, MD · Principal investigator
    Recruiting
  • Complejo Hospitalario Reina Sofia
    Cordoba, E-14004, Spain
    Withdrawn
  • Hospital Universitario Virgen de las Nieves
    Granada, E-18014, Spain
    • Daniel Garrote, MD · Principal investigator
    Recruiting
  • Complejo Hospitalario Juan Canalejo
    La Coruña, E-15006, Spain
    • Pedro Llinares, MD · Principal investigator
    Recruiting
  • Hospital General Universitario Gregorio Marañón
    Madrid, E-28007, Spain
    • Patricia Muñoz, MD · Principal investigator
    Recruiting
  • Hospital Ramon y Cajal
    Madrid, E-28034, Spain
    • Jesus Fortun, MD · Principal investigator
    Recruiting
  • Hospital Universitario Puerta de Hierro
    Madrid, E-28035, Spain
    • Antonio Ramos, MD · Principal investigator
    Recruiting
  • Hospital 12 de Octubre
    Madrid, E-28041, Spain
    • Rafael San Juan, MD · Principal investigator
    Recruiting
  • Complejo Hospitalario Carlos Haya
    Malaga, E-29010, Spain
    • Cesar Aragon, MD · Principal investigator
    Recruiting
  • Complejo Hospitalario Universitario de Santiago
    Santiago de Compostela, E-15706, Spain
    • Evaristo Varo, MD · Principal investigator
    Recruiting
  • Hospital Universitario Virgen del Rocío
    Sevilla, E-41013, Spain
    • Jose-Miguel Cisneros, MD · Principal investigator
    Recruiting
  • Hospital Universitario La Fe
    Valencia, E-46009, Spain
    • Marino Blanes, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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].
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00333645
Lead sponsor
Grupo de Estudio de Infecciones en Transplantados
Collaborators
Merck Sharp & Dohme LLC
First posted
Jun 6, 2006
Start date
Oct 2003
Completion
Mar 2007
Last update
Apr 13, 2007

Study contacts

Jesus Fortun, MD, PhD
Contact
fortun@mi.madritel.es
+34-670-537460
Jesus Fortun, MD
study director · Hospital Ramon y Cajal, Madrid, Spain
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion