Prophylaxis With Caspofungin in High-Risk Liver Transplantation
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Grupo de Estudio de Infecciones en Transplantados.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Grupo de Estudio de Infecciones en Transplantados
ClinicalTrials.gov Identifier:
NCT00333645
First Posted: June 6, 2006
Last Update Posted: April 13, 2007
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Grupo de Estudio de Infecciones en Transplantados
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Purpose
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%.
| Condition | Intervention | Phase |
|---|---|---|
| Liver Transplantation Fungal Infection | Drug: Caspofungin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Grupo de Estudio de Infecciones en Transplantados:
Primary Outcome Measures:
- Absence of breakthrough proven/probable invasive fungal infection by day +100
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | March 2007 |
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Information from the National Library of Medicine
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
Contacts
| Contact: Jesus Fortun, MD, PhD | +34-670-537460 | fortun@mi.madritel.es |
Locations
| 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 | |
Sponsors and Collaborators
Grupo de Estudio de Infecciones en Transplantados
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Jesus Fortun, MD | Hospital Ramon y Cajal, Madrid, Spain |
More Information
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].
| ClinicalTrials.gov Identifier: | NCT00333645 History of Changes |
| Other Study ID Numbers: |
GESITRA-01 03-0409 (Spanish Drug Agency) |
| First Submitted: | June 4, 2006 |
| First Posted: | June 6, 2006 |
| 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 Caspofungin |
Echinocandins Antifungal Agents Anti-Infective Agents |