NCT01260974

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

3.5 years

First QC Date

December 15, 2010

Last Update Submit

July 17, 2012

Conditions

FungemiaMycoses

Keywords

Invasive fungal infectionsLiver TransplantationOrgan TransplantationMycosesFungus DiseasesAntifungal AgentsInvasive Mycosis

Outcome Measures

Primary Outcomes (1)

  • Invasive Fungal Infection Free follow-up

    Invasive Fungal Infection free control 1 month after beginning treatment.

    1 month

Secondary Outcomes (4)

  • Tolerance to treatment.

    3 months

  • Study group mortality

    3 months

  • Study group morbidity

    3 months

  • Invasive Fungal Infection-free percentage of study group

    1 month

Study Arms (1)

Caspofungin

EXPERIMENTAL

Study group

Drug: Caspofungin

Interventions

CaspofunginDRUG

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

Also known as: Cancidas
Caspofungin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, Padova, 35128, Italy

RECRUITING

Related Links

MeSH Terms

Conditions

FungemiaMycosesInvasive Fungal Infections

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Umberto Cillo, MD

    Azienda Ospedaliera Universitaria di Padova

    PRINCIPAL INVESTIGATOR

  • Daniele Neri, MD

    Azienda Ospedaliera Universitaria di Padova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umberto Cillo, MD

CONTACT

+390498218624cillo@unipd.it

Laura Saracino, MBS

CONTACT

+390498218624lasaracino@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

May 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

IT(1)