A Phase 2 interventional study of Caspofungin in Fungemia and Mycoses, sponsored by Azienda Ospedaliera di Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-18.
Sponsored by Azienda Ospedaliera di Padova · Phase 2, Interventional, and Prevention
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).
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.
32 studies on the registry are indexed under Fungemia; 3 are open to participants now.
This study's planned enrollment of 38 is below the median of 200 across 20 interventional studies indexed under Fungemia.
Browse Fungemia studies →Azienda Ospedaliera di Padova is the lead sponsor of 38 studies on the registry; 13 are open to participants now.
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At least one of the following criteria:
Exclusion Criteria:
Subjects being removed from the trial shall be replaced.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study group
Drug: Caspofungin
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
Also known as: Cancidas
Invasive Fungal Infection Free follow-up
Invasive Fungal Infection free control 1 month after beginning treatment.
Time frame: 1 month
Tolerance to treatment.
Tolerance to treatment, with major focus on nephrotoxicity.
Time frame: 3 months
Study group mortality
Assessment of study group mortality, compared to control
Time frame: 3 months
Study group morbidity
Assessment of study group morbidity, compared to control
Time frame: 3 months
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
Time frame: 1 month
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Caspofungin
Azienda Ospedaliera di Padova