Prophylaxis With Caspofungin in High-Risk Liver Transplantation
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ClinicalTrials.gov Identifier: NCT00333645 |
Recruitment Status
: Unknown
Verified December 2006 by Grupo de Estudio de Infecciones en Transplantados.
Recruitment status was: Recruiting
First Posted
: June 6, 2006
Last Update Posted
: April 13, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Transplantation Fungal Infection | Drug: Caspofungin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 70 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients |
Study Start Date : | October 2003 |
Study Completion Date : | March 2007 |
- Absence of breakthrough proven/probable invasive fungal infection by day +100
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333645
Contact: Jesus Fortun, MD, PhD | +34-670-537460 | fortun@mi.madritel.es |
Spain | |
Hospital de Cruces | Recruiting |
Barakaldo, Spain, E-48903 | |
Principal Investigator: Miguel Montejo, MD | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, E-08035 | |
Principal Investigator: Joan Gavaldà, MD | |
Complejo Hospitalario Reina Sofia | Withdrawn |
Cordoba, Spain, E-14004 | |
Hospital Universitario Virgen de las Nieves | Recruiting |
Granada, Spain, E-18014 | |
Principal Investigator: Daniel Garrote, MD | |
Complejo Hospitalario Juan Canalejo | Recruiting |
La Coruña, Spain, E-15006 | |
Principal Investigator: Pedro Llinares, MD | |
Hospital General Universitario Gregorio Marañón | Recruiting |
Madrid, Spain, E-28007 | |
Principal Investigator: Patricia Muñoz, MD | |
Hospital Ramon y Cajal | Recruiting |
Madrid, Spain, E-28034 | |
Principal Investigator: Jesus Fortun, MD | |
Hospital Universitario Puerta de Hierro | Recruiting |
Madrid, Spain, E-28035 | |
Principal Investigator: Antonio Ramos, MD | |
Hospital 12 de Octubre | Recruiting |
Madrid, Spain, E-28041 | |
Principal Investigator: Rafael San Juan, MD | |
Complejo Hospitalario Carlos Haya | Recruiting |
Malaga, Spain, E-29010 | |
Principal Investigator: Cesar Aragon, MD | |
Complejo Hospitalario Universitario de Santiago | Recruiting |
Santiago de Compostela, Spain, E-15706 | |
Principal Investigator: Evaristo Varo, MD | |
Hospital Universitario Virgen del Rocío | Recruiting |
Sevilla, Spain, E-41013 | |
Principal Investigator: Jose-Miguel Cisneros, MD | |
Hospital Universitario La Fe | Recruiting |
Valencia, Spain, E-46009 | |
Principal Investigator: Marino Blanes, MD |
Study Director: | Jesus Fortun, MD | Hospital Ramon y Cajal, Madrid, Spain |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00333645 History of Changes |
Other Study ID Numbers: |
GESITRA-01 03-0409 (Spanish Drug Agency) |
First Posted: | June 6, 2006 Key Record Dates |
Last Update Posted: | April 13, 2007 |
Last Verified: | December 2006 |
Keywords provided by Grupo de Estudio de Infecciones en Transplantados:
Liver transplantation Invasive fungal infection Invasive aspergillosis Prophylaxis Caspofungin |
Additional relevant MeSH terms:
Infection Mycoses Invasive Fungal Infections Caspofungin |
Echinocandins Antifungal Agents Anti-Infective Agents |