Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients (CPHRLTX)
Recruitment status was Recruiting
|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|
- 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.
- 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
|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)|
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
Other Name: Cancidas
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260974
|Contact: Umberto Cillo, MDfirstname.lastname@example.org|
|Contact: Laura Saracino, MBSemail@example.com|
|Azienda Ospedaliera di Padova||Recruiting|
|Padova, Italy, 35128|
|Contact: Umberto Cillo, MD +390498218624 firstname.lastname@example.org|
|Contact: Laura Saracino, MBS +390498218624 email@example.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|
|Principal Investigator:||Umberto Cillo, MD||Azienda Ospedaliera Universitaria di Padova|
|Principal Investigator:||Daniele Neri, MD||Azienda Ospedaliera Universitaria di Padova|