Evidence map›Paper›PMID 25520332›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients.

Faouzi Saliba, Andreas Pascher, Olivier Cointault, Pierre-François Laterre, Carlos Cervera, Jan J De Waele, Umberto Cillo, Róbert M Langer, Manuela Lugano, Bo Göran-Ericzon and 7 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01058174 (Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01058174 phase3completednot on this map

Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

TypeinterventionalSponsorAstellas Pharma IncRan2009 to 2012Enrolled350ConditionsLiver Transplantation, MycosesArmsmicafungin, fluconazole, liposomal amphotericin B, caspofungin
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 77 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Brazilian guidelines for the diagnosis and treatment of candidemia and invasive candidiasis in adults and children.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Guideline
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Limitations of antifungal prophylaxis in preventing invasiveAntimicrobial agents and chemotherapy · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Antifungal stewardship in solid organ transplantation.Transplant infectious disease : an official journal of the Transplantation Society · 2022
    Review
  13. Fungal infections following liver transplantation.World journal of hepatology · 2021
    Review
  14. Budget Impact of Microbial Cell-Free DNA Testing Using the KariusApplied health economics and health policy · 2021
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 16 institutions in 11 countries.

Faouzi SalibaHôpital Paul Brousse, Villejuif, France.
Andreas PascherCharite Universitätsmedizin, Berlin, Germany.
Olivier CointaultHôpital de Rangueil, Toulouse, France.
Pierre-François LaterreSt Luc University Hospital, Université catholique de Louvain, Brussels, Belgium.
Carlos CerveraHospital Clinic i Provincial, Barcelona, Spain.
Jan J De WaeleGhent University Hospital, Belgium.
Umberto CilloAzienda Ospedaliera di Padova, Italy.
Róbert M LangerSemmelweis University, Budapest, Hungary.
Manuela LuganoAzienda Ospedaliero Universitaria Misericordia, Udine, Italy.
Bo Göran-EriczonKarolinska University Hospital, Huddinge, Sweden.
Stephen PhillipsAstellas Pharma Europe, Leiden, The Netherlands.
Lorraine TweddleAstellas Pharma Europe Medical Affairs, Chertsey, United Kingdom.
Andreas KarasAstellas Pharma Europe Medical Affairs, Chertsey, United Kingdom.
Malcolm BrownAstellas Pharma Global Medical Affairs, Northbrook, Illinois.
Lutz FischerUniversity Medical Center Hamburg-Eppendorf, Germany.
TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators
TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators
Astellas Pharma (Japan) · JPAstellas Pharma (United Kingdom) · GBAzienda Ospedale - Università Padova · ITHôpital Paul-Brousse · FRHospital Clínic de Barcelona · ESKarolinska University Hospital · SESemmelweis University · HUUniversität Hamburg · DECharité - Universitätsmedizin Berlin · DEGhent University Hospital · BEHôpital Rangueil · FRUCLouvain · BEAstellas Pharma (Netherlands) · NLAstellas Pharma (United States) · USCliniques Universitaires Saint-Luc · BEEppendorf (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInvasive fungal infection (IFI) following liver transplant is associated with significant morbidity and mortality. Antifungal prophylaxis is rational for liver transplant patients at high IFI risk.

methodsIn this open-label, noninferiority study, patients were randomized 1:1 to receive intravenous micafungin 100 mg or center-specific standard care (fluconazole, liposomal amphotericin B, or caspofungin) posttransplant. The primary endpoint was clinical success (absence of a proven/probable IFI and no need for additional antifungals) at end of prophylaxis (EOP). Noninferiority (10% margin) of micafungin vs standard care was assessed in the per protocol and full analysis sets. Safety assessments included adverse events and liver and kidney function tests.

resultsThe full analysis set comprised 344 patients (172 micafungin; 172 standard care). Mean age was 51.2 years; 48.0% had a Model for End-Stage Liver Disease score ≥20. At EOP (mean treatment duration, 17 days), clinical success was 98.6% for micafungin and 99.3% for standard care (Δ standard care - micafungin [95% confidence interval], 0.7% [-2.7% to 4.4%]) in the per protocol set and 96.5% and 93.6%, respectively (-2.9% [-8.0% to 1.9%]), in the full analysis set. Incidences of drug-related adverse events for micafungin and standard care were 11.6% and 16.3%, leading to discontinuation in 6.4% and 11.6% of cases, respectively. At EOP, liver function tests were similar but creatinine clearance was higher in micafungin- vs standard care-treated patients.

conclusionsMicafungin was noninferior to standard care as antifungal prophylaxis in liver transplant patients at high risk for IFI. Adverse event profiles and liver function at EOP were similar, although kidney function was better with micafungin. CLINICAL TRIALS REGISTRATION: NCT01058174.

Indexed as

Transplant RecipientsAdministration, IntravenousAdolescentAdultAgedAged, 80 and overAntifungal AgentsChemopreventionDrug-Related Side Effects and Adverse ReactionsEchinocandinsFemaleHumansKidney Function TestsLipopeptidesLiver Function TestsLiver TransplantationAntifungal AgentsEchinocandinsLipopeptidesMicafunginantifungal therapyinfectionliver transplantmicafunginprophylaxis

Identifiers

PMID25520332
PMCPMC4357288
OpenAlexW2132994229

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.