Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

Mycoses Clinical Trial

— CPHRLTX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01260974
• Other study ID #: 1768P
• Secondary ID: 2008-007950-36
• Status: Recruiting
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: July 17, 2012
• Start date: May 2009
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Azienda Ospedaliera di Padova
• Contact: Umberto Cillo, MD
• Phone: +390498218624
• Email: cillo[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungemia
• Mycoses

Intervention

Drug:
• Caspofungin
50mg/dd for 21dd, starting within 24h from Liver Transplantation.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Fungal Infection Free follow-up	Invasive Fungal Infection free control 1 month after beginning treatment.	1 month	No
Secondary	Tolerance to treatment.	Tolerance to treatment, with major focus on nephrotoxicity.	3 months	Yes
Secondary	Study group mortality	Assessment of study group mortality, compared to control	3 months	Yes
Secondary	Study group morbidity	Assessment of study group morbidity, compared to control	3 months	Yes
Secondary	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	1 month	Yes

External Links

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