Evidence map›Paper›PMID 16678903›Full record

Trial reportThe Journal of infection2006

Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis.

David W Denning, Kieren A Marr, Wendi M Lau, David P Facklam, Voravit Ratanatharathorn, Cornelia Becker, Andrew J Ullmann, Nita L Seibel, Patricia M Flynn, Jo-Anne H van Burik and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The Journal of infection, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00036166 (An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis), which is not on this map. Cited by 68 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 9 pooled it
15.2field-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.

NCT00036166 phase2completednot on this map

An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

TypeinterventionalSponsorAstellas Pharma IncRan1999 to 2002Enrolled326ConditionsAspergillosisArmsFK463
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 9 syntheses or guidelines pooled it, 294 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Guideline
  4. Guideline
  5. Salvage combination antifungal therapy for acute invasive aspergillosis may improve outcomes: a systematic review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2014
    Pooled it
  6. Pooled it
  7. Guideline
  8. Antifungal therapy in children: an update.European journal of pediatrics · 2013
    Pooled it
  9. Guideline
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. ISCCM Position Statement on the Management of Invasive Fungal Infections in the Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024
    Article
  16. Article
  17. Review
  18. Systemic Antifungal Therapy for Invasive Pulmonary Infections.Journal of fungi (Basel, Switzerland) · 2023
    Review
  19. Review
  20. Therapeutic Approaches for CombatingCurrent drug targets · 2022
    Review

8 more citing papers are in PubMed but not listed here.

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

12 authors at 10 institutions in 3 countries.

David W DenningEducation and Research Centre, Wythenshawe Hospital and University of Manchester, Academic Department of Medicine and Surgery, Southmoor Road, Manchester M23 9LT, UK. ddenning@manchester.ac.uk
Kieren A Marr
Wendi M Lau
David P Facklam
Voravit Ratanatharathorn
Cornelia Becker
Andrew J Ullmann
Nita L Seibel
Patricia M Flynn
Jo-Anne H van Burik
Donald N Buell
Thomas F Patterson
Astellas Pharma (United States) · USChildren's National · USFred Hutch Cancer Center · USJohannes Gutenberg University Mainz · DEKlinik und Poliklinik für Psychosomatische Medizin und Psychotherapie · DESt. Jude Children's Research Hospital · USThe Barbara Ann Karmanos Cancer Institute · USThe University of Texas Health Science Center at San Antonio · USUniversity of Manchester · GBUniversity of Minnesota · US

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundMicafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species. This study evaluated the safety and efficacy of micafungin in patients with proven or probable invasive aspergillosis (IA).

methodsA multinational, non-comparative study was conducted to examine proven or probable (pulmonary only) Aspergillus species infection in a wide variety of patient populations. The study employed an open-label design utilizing micafungin alone or in combination with another systemic antifungal agent. Criteria for IA and therapeutic responses were judged by an independent panel.

resultsOf the 331 patients enrolled, only 225 met diagnostic criteria for IA as determined by the independent panel and received at least one dose of micafungin. Patients included 98/225 who had undergone hematopoietic stem cell transplantation (HSCT) (88/98 allogeneic), 48 with graft versus host disease (GVHD), and 83/225 who had received chemotherapy for hematologic malignancy. A favorable response rate at the end of therapy was seen in 35.6% (80/225) of patients. Of those only treated with micafungin, favorable responses were seen in 6/12 (50%) of the primary and 9/22 (40.9%) of the salvage therapy group, with corresponding numbers in the combination treatment groups of 5/17 (29.4%) and 60/174 (34.5%) of the primary and salvage treatment groups, respectively. Of the 326 micafungin-treated patients, 183 (56.1%) died during therapy or in the 6-week follow-up phase; 107 (58.5%) deaths were attributable to IA.

conclusionsMicafungin as primary or salvage therapy proved efficacious and safe in high-risk patients with IA, although patient numbers are small in the micafungin-only groups.

Indexed as

Acute DiseaseAdolescentAdultAgedAged, 80 and overAntifungal AgentsAspergillosisChildChild, PreschoolDrug Therapy, CombinationEchinocandinsFemaleHumansInfantLipopeptidesLipoproteinsAntifungal AgentsEchinocandinsLipopeptidesLipoproteinsMicafunginPeptides, Cyclic

Identifiers

PMID16678903
PMCPMC7132396
OpenAlexW1968047266

What OpenQuestion holds

Textmetadata
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.