Evidence map›Paper›PMID 28575414›Full record

Trial reportThe Journal of antimicrobial chemotherapy2017

Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia.

Oliver A Cornely, Thibaut Leguay, Johan Maertens, Maria J G T Vehreschild, Achilles Anagnostopoulos, Carlo Castagnola, Luisa Verga, Christina Rieger, Mustafa Kondakci, Georg Härter and 12 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
6.5field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Review
  13. Antifungal Prophylaxis and Treatment of Breakthrough Invasive Fungal Diseases in High-Risk Hematology Patients: A Prospective Observational Multicenter Study.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2025
    Article
  14. Article
  15. Review
  16. Article
  17. Smart Nanocarrier-Based Cancer Therapeutics.Cancer treatment and research · 2023
    Article
  18. Review
  19. Article
  20. Article
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

22 authors at 18 institutions in 10 countries.

Oliver A CornelyCologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Department I of Internal Medicine, Clinical Trials Centre Cologne (ZKS), Center for Integrated Oncology (CIO KölnBonn), German Centre for Infection Research (DZIF), partner site Bonn-Cologne, University of Cologne, Cologne, Germany.
Thibaut LeguayService d'hématologie clinique et Thérapie cellulaire, Hôpital du Haut-Lévèque, CHU de Bordeaux, France.
Johan MaertensKU Leuven-University of Leuven, Department of Microbiology and Immunology, University Hospitals Leuven, Department of Hematology, B-3000 Leuven, Belgium.
Maria J G T VehreschildDepartment I of Internal Medicine, University of Cologne, Cologne, Germany.
Achilles AnagnostopoulosHaematology Department - BMT Unit, George Papanicolaou Hospital, Thessaloniki 57010, Greece.
Carlo CastagnolaDepartment of Hematology Oncology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
Luisa VergaOspedale San Gerardo, Monza, Italy.
Christina RiegerMedizinische Klinik und Poliklinik III, Klinikum der Universität München, Munich, Germany.
Mustafa KondakciKlinik für Hämatologie, Onkologie und klin. Immunologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.
Georg HärterZentrum für Hormon- und Stoffwechselerkrankungen und Infektiologie, MVZ Endokrinologikum Ulm, and Department of Internal Medicine III, Ulm University Hospital Medical Center, Ulm, Germany.
Rafael F DuarteDepartment of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid 28222, Spain.
Bernardino AllioneHematology, Ospedale S. Giovanni Battista Molinette, Torino, Italy.
Catherine CordonnierAP-HP-Henri Mondor, Hematology Department and University Paris-Est Creteil, F-94010 Créteil, France.
Claus Peter HeusselThoraxklinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.
C Orla MorrisseyDepartment of Infectious Diseases, Alfred Health and Monash University, Melbourne, Australia.
Samir G AgrawalDivision of Haemato-Oncology, St Bartholomew's Hospital, Barts Cancer Institute, Queen Mary University, London, UK.
J Peter DonnellyDepartment of Haematology, Radboud UMC, Nijmegen, the Netherlands.
Mark BresnikGilead Sciences, Foster City, CA, USA.
Michael J HawkinsGilead Sciences, Foster City, CA, USA.
Will GarnerGilead Sciences, Foster City, CA, USA.
Nicola GökbugetDepartment of Medicine II, University Hospital, Goethe University, Frankfurt, Germany.
AmBiGuard Study Group
Gilead Sciences (United States) · USUniversity of Cologne · DEAssistance Publique – Hôpitaux de Paris · FRAzienda Ospedaliera San Gerardo · ITAzienda Ospedaliero Universitaria San Giovanni Battista · ITGoethe University Frankfurt · DEG. Papanikolaou General Hospital · GRHeidelberg University · DEHeinrich Heine University Düsseldorf · DEHôpital Cardiologique du Haut-Lévêque · FRHospital Universitario Puerta de Hierro Majadahonda · ESKU Leuven · BELMU Klinikum · DEMonash University · AUPoliclinico San Matteo Fondazione · ITRadboud University Nijmegen · NLSt Bartholomew's Hospital · GBUniversity Hospital Ulm · DE

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

Objectives: To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL). Patients and methods: In a double-blind multicentre Phase 3 study, patients received prophylactic liposomal amphotericin B (L-AMB) at 5 mg/kg intravenously or placebo twice weekly in a 2:1 random allocation during remission-induction treatment. The primary endpoint was the development of proven or probable IFD. Secondary endpoints included those focused on the safety and tolerability of prophylactic L-AMB. Results: Three hundred and fifty-five patients from 86 centres in Europe and South America received at least one dose of L-AMB ( n =  237) or placebo ( n =  118). Rates of proven and probable IFD assessed independently were 7.9% (18/228) in the L-AMB group and 11.7% (13/111) in the placebo group ( P  =   0.24). Rates of possible IFD were 4.8% (11/228) in the L-AMB and 5.4% (6/111) in the placebo group ( P  =   0.82). The remission-induction phase was a median of 22 days for both groups. Overall mortality was similar between the groups: 7.2% (17/237) for L-AMB and 6.8% (8/118) for placebo ( P  =   1.00). Hypokalaemia and creatinine increase were significantly more frequent with L-AMB. Conclusions: The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, and was not significantly different in patients receiving L-AMB, suggesting that the L-AMB regimen studied is not effective as prophylaxis against IFD. The IFD rate appears higher than previously reported, warranting further investigation. Tolerability of L-AMB was what might be expected. Further studies are needed to determine the optimal antifungal strategy during remission-induction chemotherapy of ALL.

Indexed as

Administration, IntravenousAdolescentAdultAgedAged, 80 and overAmphotericin BAntifungal AgentsChemopreventionDouble-Blind MethodEuropeFemaleHumansInvasive Fungal InfectionsMaleMiddle AgedPlacebosAmphotericin BAntifungal Agentsliposomal amphotericin BPlacebos

Identifiers

PMID28575414
PMCPMC5890735
OpenAlexW2618208559

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.