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

Primary Purpose

Fungemia, Mycoses

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Caspofungin

About this trial

This is an interventional prevention trial for Fungemia focused on measuring Invasive fungal infections, Liver Transplantation, Organ Transplantation, Mycoses, Fungus Diseases, Antifungal Agents, Invasive Mycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Azienda Ospedaliera di PadovaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caspofungin

Arm Description

Study group

Outcomes

Primary Outcome Measures

Invasive Fungal Infection Free follow-up

Invasive Fungal Infection free control 1 month after beginning treatment.

Secondary Outcome Measures

Tolerance to treatment.

Tolerance to treatment, with major focus on nephrotoxicity.

Study group mortality

Assessment of study group mortality, compared to control

Study group morbidity

Assessment of study group morbidity, compared to control

Invasive Fungal Infection-free percentage of study group

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

Full Information

NCT ID

NCT01260974

First Posted

December 15, 2010

Last Updated

July 17, 2012

Sponsor

Azienda Ospedaliera di Padova

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01260974

Brief Title

Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

Acronym

CPHRLTX

Official Title

Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera di Padova

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fungemia, Mycoses

Keywords

Invasive fungal infections, Liver Transplantation, Organ Transplantation, Mycoses, Fungus Diseases, Antifungal Agents, Invasive Mycosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Caspofungin

Arm Type

Experimental

Arm Description

Study group

Intervention Type

Drug

Intervention Name(s)

Caspofungin

Other Intervention Name(s)

Cancidas

Intervention Description

50mg/dd for 21dd, starting within 24h from Liver Transplantation.

Primary Outcome Measure Information:

Title

Invasive Fungal Infection Free follow-up

Description

Invasive Fungal Infection free control 1 month after beginning treatment.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Tolerance to treatment.

Description

Tolerance to treatment, with major focus on nephrotoxicity.

Time Frame

3 months

Title

Study group mortality

Description

Assessment of study group mortality, compared to control

Time Frame

3 months

Title

Study group morbidity

Description

Assessment of study group morbidity, compared to control

Time Frame

3 months

Title

Invasive Fungal Infection-free percentage of study group

Description

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

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Umberto Cillo, MD

Phone

+390498218624

cillo@unipd.it

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Saracino, MBS

Phone

+390498218624

lasaracino@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umberto Cillo, MD

Organizational Affiliation

Azienda Ospedaliera Universitaria di Padova

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniele Neri, MD

Organizational Affiliation

Azienda Ospedaliera Universitaria di Padova

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Ospedaliera di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umberto Cillo, MD

Phone

+390498218624

cillo@unipd.it

First Name & Middle Initial & Last Name & Degree

Laura Saracino, MBS

Phone

+390498218624

lasaracino@gmail.com

First Name & Middle Initial & Last Name & Degree

Umberto Cillo, MD

First Name & Middle Initial & Last Name & Degree

Daniele Neri, MD

First Name & Middle Initial & Last Name & Degree

Giacomo Zanus, MD

First Name & Middle Initial & Last Name & Degree

Patrizia Boccagni, MD

First Name & Middle Initial & Last Name & Degree

Enrico Gringeri, MD

First Name & Middle Initial & Last Name & Degree

Francesco D'Amico, MD

First Name & Middle Initial & Last Name & Degree

Alessandro Vitale, MD

First Name & Middle Initial & Last Name & Degree

Paolo Feltracco, MD

First Name & Middle Initial & Last Name & Degree

Dino Sgarabotto, MD

First Name & Middle Initial & Last Name & Degree

Pasquale Bonsignore, MD

First Name & Middle Initial & Last Name & Degree

Marina Polacco, MD

First Name & Middle Initial & Last Name & Degree

Enrico Lodo, MD

First Name & Middle Initial & Last Name & Degree

Davide Du Puis, MD

First Name & Middle Initial & Last Name & Degree

Laura Saracino, MBS

12. IPD Sharing Statement

Links:

URL

http://www.fegatochirurgia.com/

Description

Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)

Learn more about this trial

Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

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