FungemiaPhase 2CPHRLTXNCT01260974
Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients
A Phase 2 study testing Caspofungin in people with Fungemia and Mycoses, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Caspofungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- liver re-transplantation
- fever without bacterial or viral infection
- biliodigestive
- re-laparatomy after LTx
- post LTx pancreatitis
- post LTx dialysis or renal insufficiency
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Padova
Padova, Padova, 35128
Umberto Cillo, MD, +390498218624, cillo@unipd.it
Laura Saracino, MBS, +390498218624, lasaracino@gmail.com
About this study
Official title: Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients
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).
Read the 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.
- Being tested
- Caspofungin
- Keywords
- Invasive fungal infections, Liver Transplantation, Organ Transplantation, Mycoses, Fungus Diseases, Antifungal Agents, Invasive Mycosis
- Medical subject headings
- Fungemia, Mycoses, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
Also called Cancidas
50mg/dd for 21dd, starting within 24h from Liver Transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Caspofungin | Experimental | Study group Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Fungal Infection Free follow-up
Invasive Fungal Infection free control 1 month after beginning treatment.
Measured: 1 month
Secondary outcomes (4)
Tolerance to treatment.
Tolerance to treatment, with major focus on nephrotoxicity.
Measured: 3 months
Study group mortality
Assessment of study group mortality, compared to control
Measured: 3 months
Study group morbidity
Assessment of study group morbidity, compared to control
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startMay 2009
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FungemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Umberto Cillo, MD, Principal investigator, Azienda Ospedaliera Universitaria di PadovaDaniele Neri, MD, Principal investigator, Azienda Ospedaliera Universitaria di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260974
- Sponsor's protocol ID
- 1768P
- Other IDs
- 2008-007950-36, 2008
- Acronym
- CPHRLTX
- Status last verified
- Jul 2012
- First submitted
- 15 Dec 2010
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Efficacy of Caspofungin for Antifungal Prophylaxis for Selected High Risk Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT01260974
- Acronym / sponsor ID
- CPHRLTX / 1768P
- Keywords
- Invasive fungal infections, Liver Transplantation, Organ Transplantation, Mycoses, Fungus Diseases, Antifungal Agents, Invasive Mycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2009
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caspofungin | Experimental | Drug: CaspofunginStudy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- MELD score ≥25
- liver transplantation for acute liver failure
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaspofunginAlso: Cancidas50mg/dd for 21dd, starting within 24h from Liver Transplantation. | Drug | Caspofungin |
Primary outcome
Invasive Fungal Infection Free follow-up
Time frame: 1 month
Invasive Fungal Infection free control 1 month after beginning treatment.
4 secondary outcomes
Tolerance to treatment.
Time frame: 3 months
Study group mortality
Time frame: 3 months
Study group morbidity
Time frame: 3 months
Invasive Fungal Infection-free percentage of study group
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Cillo, MD principal investigator
Azienda Ospedaliera Universitaria di Padova
Daniele Neri, MD principal investigator
Azienda Ospedaliera Universitaria di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caspofungin in people with Fungemia and Mycoses, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cillo, MD (+390498218624, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Fungal Infection Free follow-up (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.