Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260974

Acronym

CPHRLTX

Enrollment

Registered

2010-12-16

Start date

2009-05-31

Completion date

2012-11-30

Last updated

2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungemia, Mycoses

Keywords

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

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.

Interventions

DRUGCaspofungin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Invasive Fungal Infection Free follow-up	1 month	Invasive Fungal Infection free control 1 month after beginning treatment.

Secondary

Measure	Time frame	Description
Tolerance to treatment.	3 months	Tolerance to treatment, with major focus on nephrotoxicity.
Study group mortality	3 months	Assessment of study group mortality, compared to control
Study group morbidity	3 months	Assessment of study group morbidity, compared to control
Invasive Fungal Infection-free percentage of study group	1 month	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

Countries

Italy

Contacts

Primary ContactUmberto Cillo, MD

cillo@unipd.it+390498218624

Backup ContactLaura Saracino, MBS

lasaracino@gmail.com+390498218624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026