Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients (CPHRLTX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Azienda Ospedaliera di Padova.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01260974
First received: December 15, 2010
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).


Condition Intervention Phase
Fungemia
Mycoses
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: Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Invasive Fungal Infection Free follow-up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Invasive Fungal Infection free control 1 month after beginning treatment.


Secondary Outcome Measures:
  • Tolerance to treatment. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Tolerance to treatment, with major focus on nephrotoxicity.

  • Study group mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Assessment of study group mortality, compared to control

  • Study group morbidity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Assessment of study group morbidity, compared to control

  • Invasive Fungal Infection-free percentage of study group [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Invasive Fungal Infection-free percentage of study group, evaluated at 1 month from beginning of study and assessment of mortality and morbidity in the control group


Estimated Enrollment: 38
Study Start Date: May 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofungin
Study group
Drug: Caspofungin
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
Other Name: Cancidas

Detailed Description:

The prophylactic use of anti-fungal drugs is crucial in order to decrease the incidence of invasive fungal infections in transplantation patients.

Invasive fungal infections (IFI) ---organ-related or systemic infections--- are in fact one of the most important causes of morbidity and mortality in patients undergoing solid organ transplantation (respectively, 70% and 100%).

The rationale of the proposed study is to evaluate a new protocol for the prevention of IFIs through the use of a newly introduced anti-fungal, caspofungin (commercial name: Cancidas), to be used for primary prophylaxis of fungal infections post-OLTx and to compare to drugs already in use (eg. amphotericin B, fluconazole), until 21 days after liver transplantation.

The aim of this study is determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).

The possibility of reducing the risk of fungal infections in liver transplant patients (usually between 7 and 42%) is therefore an important clinical goal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients shortlisted for liver transplantation
  • negative pregnancy test for fertile female patients 7 days prior enrollment
  • patients who can adequately communicate with study responsibles, who can understand and answer to protocol requirements

At least one of the following criteria:

  • MELD score ≥25
  • liver transplantation for acute liver failure
  • liver re-transplantation
  • fever without bacterial or viral infection
  • biliodigestive
  • re-laparatomy after LTx
  • post LTx pancreatitis
  • post LTx dialysis or renal insufficiency

Exclusion Criteria:

  • Patients enrolled in other clinical trial or those having received other experimental drugs 4 weeks prior to enrollment
  • Patients with a known fungal infection (based on the EORTC/MSG criteria)
  • Patients with history of hypersensitivity to the drug, or other counterindications
  • Patients with a diagnosed Severe Hepatic insufficiency (CTP >9)
  • Physical or hematochemical alterations
  • Clinically relevant psychological alterations in the 2 weeks preceding enrollment such as to interfere, in the researchers opinion, with the goal of the study
  • Patients being treated with Ciclosporin A

Subjects being removed from the trial shall be replaced.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260974

Contacts
Contact: Umberto Cillo, MD +390498218624 cillo@unipd.it
Contact: Laura Saracino, MBS +390498218624 lasaracino@gmail.com

Locations
Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Umberto Cillo, MD    +390498218624    cillo@unipd.it   
Contact: Laura Saracino, MBS    +390498218624    lasaracino@gmail.com   
Principal Investigator: Umberto Cillo, MD         
Sub-Investigator: Daniele Neri, MD         
Sub-Investigator: Giacomo Zanus, MD         
Sub-Investigator: Patrizia Boccagni, MD         
Sub-Investigator: Enrico Gringeri, MD         
Sub-Investigator: Francesco D'Amico, MD         
Sub-Investigator: Alessandro Vitale, MD         
Sub-Investigator: Paolo Feltracco, MD         
Sub-Investigator: Dino Sgarabotto, MD         
Sub-Investigator: Pasquale Bonsignore, MD         
Sub-Investigator: Marina Polacco, MD         
Sub-Investigator: Enrico Lodo, MD         
Sub-Investigator: Davide Du Puis, MD         
Sub-Investigator: Laura Saracino, MBS         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Umberto Cillo, MD Azienda Ospedaliera Universitaria di Padova
Principal Investigator: Daniele Neri, MD Azienda Ospedaliera Universitaria di Padova
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01260974     History of Changes
Other Study ID Numbers: 1768P, 2008-007950-36
Study First Received: December 15, 2010
Last Updated: July 17, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:
Invasive fungal infections
Liver Transplantation
Organ Transplantation
Mycoses
Fungus Diseases
Antifungal Agents
Invasive Mycosis

Additional relevant MeSH terms:
Mycoses
Caspofungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014