Evidence map›Paper›PMID 31355956›Full record

Trial reportMycoses2019

Efficacy and safety of combination antifungal therapy in Korean haematological patients with invasive aspergillosis.

Dong-Gun Lee, Hye-Jung Lee, Jean Li Yan, Stephen Sheng-Fong Lin, Jalal A Aram

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Mycoses, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00531479 (A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT00531479 phase3completednot on this map

A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled459ConditionsAspergillosisArmsvoriconazole, anidulafungin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Allicin shows antifungal efficacy againstFrontiers in microbiology · 2022
    Article
  4. 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

5 authors.

Dong-Gun LeeDivision of Infectious Diseases, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Hye-Jung LeePfizer Inc, Seoul, South Korea.
Jean Li YanPfizer Inc, New York, NY, USA.
Stephen Sheng-Fong LinPfizer Inc, New York, NY, USA.
Jalal A AramPfizer Inc, New York, NY, USA.

Funding

Pfizer Inc
6 · The paper itself

Abstract

This randomised, double-blind, placebo-controlled trial assessed the efficacy, safety and tolerability of voriconazole+anidulafungin (combination) or voriconazole+placebo (monotherapy) for invasive aspergillosis (IA; NCT00531479). We present a post hoc analysis of Korean and non-Korean patients with IA (including baseline positive serum galactomannan [GM]). Immunocompromised patients ≥ 16 years with IA were randomised 1:1, combination or monotherapy, for ≥ 2 weeks' treatment. The primary endpoint was 6- and 12-week all-cause mortality (Korean modified intent-to-treat [mITT] population). Overall, 454 patients enrolled (Koreans: 56 [combination: 28, monotherapy: 28], non-Koreans: 398 [combination: 200, monotherapy: 198]). The mITT population comprised 40 Koreans (combination: 23; monotherapy: 17) and 237 non-Koreans (combination: 112; monotherapy: 125). Week 6 treatment difference in mortality rate between combination and monotherapy was -6.4% in non-Koreans. This reduction was more marked in Koreans (-22.4%). Week 12 difference in all-cause mortality between combination and monotherapy was -17.7% (Koreans) and -20.2% at Week 6 (Koreans; positive baseline GM). Week 6 mortality (Koreans [mITT]; baseline GM >0.5-2.0) was 0/13 (combination) and 2/6 (monotherapy). Serious adverse events were numerically higher for combination than monotherapy (Koreans: 57.1%, 46.4%; non-Koreans: 49.5%, 46.0%). In Koreans, combination therapy was associated with marginally better outcomes than monotherapy and more so than in non-Koreans.

Indexed as

AdolescentAdultAgedAged, 80 and overAnidulafunginAntifungal AgentsAsian PeopleDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationFemaleHematologic NeoplasmsHumansImmunocompromised HostInvasive Pulmonary AspergillosisMaleAnidulafunginAntifungal AgentsPlacebosVoriconazoleanidulafungincombination antifungalsechinocandinsgalactomannanhaematologic malignanciesimmunocompromisedinvasive aspergillosisvoriconazole

Identifiers

PMID31355956
PMCPMC7003761

What OpenQuestion holds

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LicenceCC BY
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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.