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Liver TransplantationPhase 2NCT00333645

Prophylaxis With Caspofungin in High-Risk Liver Transplantation

A Phase 2 study testing Caspofungin in people with Liver Transplantation and Fungal Infection, run by Grupo de Estudio de Infecciones en Transplantados at 13 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplantation, Fungal Infection
What is being tested?
Caspofungin
How many people
70 participants
Where
13 sitesSpain
Study dates
Oct 2003to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

Jesus Fortun, MD, PhD contact

+34-670-537460

fortun@mi.madritel.es

13 sites in 1 country

Spain13 sites, 12 recruiting

  • Complejo Hospitalario Juan Canalejo

    A Coruña, E-15006

    Pedro Llinares, MD

    Recruiting

  • Hospital de Cruces

    Barakaldo, E-48903

    Miguel Montejo, MD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, E-08035

    Joan Gavaldà, MD

    Recruiting

  • Complejo Hospitalario Reina Sofia

    Córdoba, E-14004

    Withdrawn

  • Hospital Universitario Virgen de las Nieves

    Granada, E-18014

    Daniel Garrote, MD

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, E-28007

    Patricia Muñoz, MD

    Recruiting

  • Hospital Ramon y Cajal

    Madrid, E-28034

    Jesus Fortun, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Madrid, E-28035

    Antonio Ramos, MD

    Recruiting

  • Hospital 12 de Octubre

    Madrid, E-28041

    Rafael San Juan, MD

    Recruiting

  • Complejo Hospitalario Carlos Haya

    Málaga, E-29010

    Cesar Aragon, MD

    Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, E-15706

    Evaristo Varo, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, E-41013

    Jose-Miguel Cisneros, MD

    Recruiting

  • Hospital Universitario La Fe

    Valencia, E-46009

    Marino Blanes, MD

    Recruiting

Other trials in Spain

About this study

Official title: Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients

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%.

Being tested
Caspofungin
Keywords
Liver transplantation, Invasive fungal infection, Invasive aspergillosis, Prophylaxis, Caspofungin
Medical subject headings
Mycoses, Invasive Fungal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaspofunginDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2006 (estimated)
  2. Study startOct 2003
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333645
Sponsor's protocol ID
GESITRA-01
Other IDs
03-0409 (Spanish Drug Agency)
Status last verified
Dec 2006
First submitted
4 Jun 2006
Last updated
13 Apr 2007
Results posted
No

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].

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caspofungin in people with Liver Transplantation and Fungal Infection, run by Grupo de Estudio de Infecciones en Transplantados at 13 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jesus Fortun, MD, PhD (+34-670-537460, fortun@mi.madritel.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of breakthrough proven/probable invasive fungal infection by day +100. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00333645, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2007.

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