A Phase 4 interventional study of Anidulafungin and Fluconazole in Mycoses, Fungemia and Central Nervous System Fungal Infections, sponsored by University of Pittsburgh. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-17.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Prevention
The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients
A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.
Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.
Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.
Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.
The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.
32 studies on the registry are indexed under Fungemia; 3 are open to participants now.
This study's enrollment of 200 is close to the median of 200 across 20 interventional studies indexed under Fungemia.
Browse Fungemia studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Fungemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mycoses. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
anti-fungal agent
Drug: Anidulafungin
anti-fungal agent
Drug: Fluconazole
200 mg IV loading dose followed by 100 mg qd for 21 days
Also known as: Eraxis
400 mg IV for 21 days
Also known as: DIFLUCAN
Frequency of Fungal Infection
Time frame: 90 days post enrollment
Need for Additional Antifungal Therapy
Time frame: 90 days post enrollment
| Milestone | Anidulafungin | Fluconazole |
|---|---|---|
| Started | 100 | 100 |
| Completed | 98 | 99 |
| Not completed | 2 | 1 |
| participants | Anidulafungin | Fluconazole |
|---|---|---|
| Frequency of Fungal Infection | 5 | 8 |
| participants | Anidulafungin | Fluconazole |
|---|---|---|
| Need for Additional Antifungal Therapy | 11 | 11 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anidulafungin | — | 1/98 (1%) | 11/98 (11.2%) |
| Fluconazole | — | 0/99 (0%) | 11/99 (11.1%) |
| Event | Anidulafungin | Fluconazole |
|---|---|---|
| Prolonged QT intervalCardiac disorders | 1/98 | 0/99 |
| Event | Anidulafungin | Fluconazole |
|---|---|---|
| deathsGeneral disorders | 11/98 | 11/99 |
| Age, Categorical(Participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 89 | 89 | 178 |
| >=65 years | 11 | 11 | 22 |
| Age, Continuous(years) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Median | 58 (52 to 62) | 58 (51 to 62) | 58 (52 to 62) |
| Sex: Female, Male(Participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Female | 33 | 28 | 61 |
| Male | 67 | 72 | 139 |
| Ethnicity (NIH/OMB)(Participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Hispanic or Latino | 27 | 38 | 65 |
| Not Hispanic or Latino | 73 | 62 | 135 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| United States | 100 | 100 | 200 |
The record gives a start of Feb 2010, a primary completion of Jul 2013 and a completion of May 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Anidulafungin