Evidence map›Paper›PMID 32391919›Full record

Trial reportMycoses2020

Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.

Isao Yoshida, Akiko M Saito, Shiro Tanaka, Ilseung Choi, Michihiro Hidaka, Yasuhiko Miyata, Yoshiko Inoue, Satoshi Yamasaki, Toshiya Kagoo, Hiroatsu Iida and 18 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Mycoses, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 35% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. 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

28 authors at 12 institutions in 1 country.

Isao YoshidaDepartment of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.ORCID https://orcid.org/0000-0001-5234-0507
Akiko M SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Shiro TanakaDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Ilseung ChoiDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Yasuhiko MiyataDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yoshiko InoueDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Satoshi YamasakiDepartment of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Toshiya KagooDepartment of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
Hiroatsu IidaDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Hiromasa NiimiDepartment of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.
Takuya KomenoDepartment of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.
Chikamasa YoshidaDepartment of Hematology, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan.
Fumihito TajimaStem Cell Transplantation Center, National Hospital Organization Yonago Medical Center, Yonago, Japan.
Hideyuki YamamotoDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Ken TakaseDepartment of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Hironori UenoDepartment of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
Takeshi ShimomuraDepartment of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.
Tatsunori SakaiDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Yasuhiro NakashimaDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Chikashi YoshidaDepartment of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.
Shiro KubonishiDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Kazutaka SunamiDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Shinichiro YoshidaDepartment of Hematology, National Hospital Organization Nagasaki Medical Center, Omura, Japan.
Aki SakuraiDepartment of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Yukihiro KanekoDepartment of Bacteriology, Osaka City University Graduate School of Medicine, Osaka, Japan.
Yoshitsugu MiyazakiDepartment of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan.
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
National Hospital Organization · JPKumamoto Medical Center · JPNational Hospital Organization Mito Medical Center · JPNational Hospital Organization Kyushu Cancer Center · JPNational Kyushu Medical Center · JPShikoku Cancer Center · JPTokyo Medical Center · JPKyoto University · JPNagasaki Medical Center · JPNational Institute of Infectious Diseases · JPNational Institute of Technology, Yonago College · JPOsaka City University · JP

Funding

Grant-in-Aid for Clinical Research from the National Hospital Organization
6 · The paper itself

Abstract

backgroundFungal infections are a major complication of neutropaenia following chemotherapy. Their early diagnosis is difficult, and empirical antifungal treatment is widely used, and uses of less toxic drugs that reduce breakthrough infection are required.

objectiveWe conducted a multicentre, open-label, randomised, non-inferiority trial to compare the safety and efficacy of intravenous itraconazole (ivITCZ) and liposomal amphotericin B (LAmB) as empirical antifungal therapy in patients with haematological malignancies with neutropaenia and persistent fever.

methodsPatients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled. Patients were randomised for treatment with LAmB (3.0 mg/kg/d) or ivITCZ (induction: 400 mg/d, maintenance: 200 mg/d).

resultsObserved overall favourable response rates of 17/52 (32.7%) and 18/50 (36.0%) in the LAmB and ivITCZ groups, with a model-based estimate of a 4% difference (90% CI, -12% to 20%), did not fulfil the statistical non-inferiority criterion. In the LAmB group, there were two cases of breakthrough infection and five cases of probable invasive fungal disease, whereas in the itraconazole group, neither breakthrough infection nor probable invasive fungal disease occurred. Patients in the ivITCZ group had significantly fewer grade 3-4 hypokalaemia-related events than LAmB group patients (P < .01). The overall incidence of adverse events tended to be lower in the ivITCZ group (P = .07).

conclusionivITCZ showed similar efficacy and safety as LAmB as empirical antifungal therapy in haematological malignancy patients with febrile neutropaenia, although the small sample size and various limitations prevented demonstration of its non-inferiority.

Indexed as

Amphotericin BItraconazoleMycosesAdministration, IntravenousAdultAgedAntifungal AgentsChemotherapy-Induced Febrile NeutropeniaFemaleHematologic NeoplasmsHumansMaleMiddle AgedYoung AdultAmphotericin BAntifungal AgentsItraconazoleliposomal amphotericin Bantifungal agentschemotherapy-induced febrile neutropaeniahaematological malignancieshypokalaemiaintravenous itraconazoleliposomal amphotericin Bprobable invasive fungal diseaseprospective randomised controlled trial

Identifiers

PMID32391919
PMCPMC7497187
OpenAlexW3021078159

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.