Prophylaxis With Caspofungin in High-Risk Liver Transplantation
The recruitment status of this study is unknown because the information has not been verified recently.
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
Collaborator:
Merck
Information provided by:
Grupo de Estudio de Infecciones en Transplantados
ClinicalTrials.gov Identifier:
NCT00333645
First received: June 4, 2006
Last updated: April 12, 2007
Last verified: December 2006
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Universitario Puerta de Hierro | Recruiting |
| Madrid, Spain, E-28035 | |
| Principal Investigator: Antonio Ramos, 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 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
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) |
| Study First Received: | June 4, 2006 |
| Last Updated: | April 12, 2007 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Grupo de Estudio de Infecciones en Transplantados:
|
Liver transplantation Invasive fungal infection Invasive aspergillosis Prophylaxis Caspofungin |
Additional relevant MeSH terms:
|
Mycoses Caspofungin Echinocandins Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013