Evidence map›Paper›PMID 26270686›Full record

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

A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.

Wolfgang Knitsch, Jean-Louis Vincent, Stefan Utzolino, Bruno François, Tamás Dinya, George Dimopoulos, İlhan Özgüneş, Juan Carlos Valía, Philippe Eggimann, Cristóbal León and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized 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 NCT01122368 (An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
9.1field-weighted citation impact, top 1% 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.

NCT01122368 phase2completednot on this map

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

TypeinterventionalSponsorAstellas Pharma IncRan2010 to 2011Enrolled252ConditionsMycosesArmsmicafungin, placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 98 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Invasive Candidiasis in the Intensive Care Unit: Where Are We Now?Journal of fungi (Basel, Switzerland) · 2025
    Review
  6. Article
  7. Article
  8. Antimicrobial approach of abdominal post-surgical infections.World journal of gastrointestinal surgery · 2023
    Review
  9. Article
  10. Effect of empirical antifungal treatment on mortality in non-neutropenic critically ill patients: a propensity-matched retrospective cohort study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022
    Article
  11. Review
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Review
  17. Observational
  18. Observational
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 16 institutions in 11 countries.

Wolfgang KnitschDepartment of General, Visceral and Transplantation Surgery, Hanover Medical School.
Jean-Louis VincentDepartment of Intensive Care Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Stefan UtzolinoDepartment of General and Visceral Surgery, University of Freiburg, Freiburg im Breisgau.
Bruno FrançoisInserm CIC 1435/Medical-Surgical Intensive Care Unit, Centre Hospitalier Universitaire Dupuytren, Limoges.
Tamás DinyaInstitute of Surgery, University of Debrecen, Hungary.
George Dimopoulos2nd Intensive Care Department, University Hospital Attikon, Athens, Greece.
İlhan ÖzgüneşDepartment of Clinical Microbiology and Infectious Diseases, Eskisehir Osmangazi University Faculty of Medicine, Turkey.
Juan Carlos ValíaServicio de Anestesia y Reanimación, Hospital General Universitario, Valencia.
Philippe EggimannAdult Intensive Care Service, Department of Interdisciplinary Centers and Logistics, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Switzerland.
Cristóbal LeónIntensive Care Unit, Valme University Hospital, University of Seville, Spain.
Philippe MontraversDépartement d'Anesthésie Réanimation Chirurgicale, Centre Hospitalier Universitaire Bichat Claude Bernard and University Denis Diderot Sorbonne Cité, Paris, France.
Stephen PhillipsChiltern International, Leiden, The Netherlands.
Lorraine TweddleAstellas Pharma EMEA Medical Affairs, Chertsey, United Kingdom.
Andreas KarasAstellas Pharma EMEA Medical Affairs, Chertsey, United Kingdom.
Malcolm BrownAstellas Pharma Global Medical Affairs, Northbrook, Illinois.
Oliver A CornelyDepartment I of Internal Medicine, Clinical Trials Centre Cologne, German Centre for Infection Research, and Cologne Excellence Custer on Cellular Stress Responses in Aging-Associated Diseases, University of Cologne, Germany.
Astellas Pharma (Germany) · DEAstellas Pharma (United Kingdom) · GBAstellas Pharma (United States) · USEskişehir Osmangazi University · TRHôpital Universitaire Dupuytren · FRHospital General Universitario De Valencia · ESHospital Universitario de Valme · ESInternational Institute for Asian Studies · NLMedizinische Hochschule Hannover · DEUniversité Libre de Bruxelles · BEUniversité Paris Cité · FRUniversity General Hospital Attikon · GRUniversity Hospital of Lausanne · CHUniversity of Cologne · DEUniversity of Debrecen · HUUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at risk of invasive candidiasis (IC) and candidates for preemptive antifungal therapy.

methodsThis exploratory, randomized, double-blind, placebo-controlled trial assessed a preemptive antifungal approach with micafungin (100 mg/d) in intensive care unit patients requiring surgery for intra-abdominal infection. Coprimary efficacy variables were the incidence of IC and the time from baseline to first IC in the full analysis set; an independent data review board confirmed IC. An exploratory biomarker analysis was performed using logistic regression.

resultsThe full analysis set comprised 124 placebo- and 117 micafungin-treated patients. The incidence of IC was 8.9% for placebo and 11.1% for micafungin (difference, 2.24%; [95% confidence interval, -5.52 to 10.20]). There was no difference between the arms in median time to IC. The estimated odds ratio showed that patients with a positive (1,3)-β-d-glucan (ßDG) result were 3.66 (95% confidence interval, 1.01-13.29) times more likely to have confirmed IC than those with a negative result.

conclusionsThis study was unable to provide evidence that preemptive administration of an echinocandin was effective in preventing IC in high-risk surgical intensive care unit patients with intra-abdominal infections. This may have been because the drug was administered too late to prevent IC coupled with an overall low number of IC events. It does provide some support for using ßDG to identify patients at high risk of IC. CLINICAL TRIALS REGISTRATION: NCT01122368.

Indexed as

Pre-Exposure ProphylaxisAdolescentAdultAgedAntifungal Agentsbeta-GlucansBiomarkersCandidiasis, InvasiveDouble-Blind MethodEchinocandinsFemaleHumansIntensive Care UnitsIntraabdominal InfectionsLipopeptidesMaleAntifungal Agentsbeta-GlucansBiomarkersEchinocandinsLipopeptidesMicafunginpolysaccharide-KProteoglycansgastrointestinal surgeryintensive careinvasive candidiasismicafunginPreemptive antifungal therapy

Identifiers

PMID26270686
PMCPMC4643488
OpenAlexW2177937039

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.