Evidence map›Paper›PMID 23676114›Full record

Trial reportBMC infectious diseases2013

Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial.

Piroon Mootsikapun, Po-Ren Hsueh, Deepak Talwar, Vilma M Co, Viraj Rajadhyaksha, Moh-Lim Ong

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in BMC infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00537329 (A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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.

NCT00537329 phase3completednot on this map

A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients

TypeinterventionalSponsorPfizerRan2008 to 2009Enrolled43ConditionsCandidemiaArmsAnidulafungin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Guideline
  2. Article
  3. 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
  4. Article
  5. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019
    Article
  6. Article
  7. Article
  8. Observational
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

6 authors at 4 institutions in 5 countries.

Piroon Mootsikapun
Po-Ren Hsueh
Deepak Talwar
Vilma M Co
Viraj Rajadhyaksha
Moh-Lim Ong
Pfizer (United States) · USMakati Medical Center · PHNational Taiwan University Hospital · TWSongklanagarind Hospital · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCandidemia is a significant cause of morbidity and mortality in hospitalized patients, particularly in Asia. Anidulafungin has been reported to be an effective treatment for candidemia in Western populations, but little is known about its efficacy in Asian patients, where the clinical presentation and epidemiology may be different.

methodsAn open-label study of anidulafungin for the treatment of candidemia was recently conducted in several Asian countries. Treatment was initiated with intravenous anidulafungin, given for at least 5 days, with the option to complete treatment with oral voriconazole. The primary endpoint was global (clinical and microbiological) response, and the primary analysis was the proportion of patients in the modified intent-to-treat population with successful global response at the end of therapy. Secondary analyses included proportion with successful global response in clinically relevant patient subgroups. The safety and tolerability profile of anidulafungin and voriconazole in this population was also investigated.

resultsForty-three patients were studied, including 42 in the modified intent-to-treat population. Eighteen patients were > 65 years, the largest age subgroup, and 21 had central venous catheters. The most common Candida species causing infection were C. tropicalis (n = 18) and C. albicans (n = 10). In the primary analysis, 73.8% had a successful global response at end of therapy. Success rates in subgroups were: 72.2% for C. tropicalis and 71.4% for C. albicans infection, 58.8% for patients > 65 years, and 81.0% for patients with central venous catheters. Safety and tolerability were comparable with the known profiles for anidulafungin (and voriconazole).

conclusionsAlthough the epidemiology of Candida infections was different in this open-label study, the efficacy of anidulafungin in Asian patients with documented candidemia was consistent with previous studies in Western populations. No new safety concerns were identified.

trial registrationhttp://www.clinicaltrials.gov identifier NCT00537329.

Indexed as

Administration, IntravenousAdministration, OralAdolescentAdultAgedAnidulafunginAntifungal AgentsCandidemiaEchinocandinsFemaleHumansMaleMiddle AgedPyrimidinesTreatment OutcomeTriazolesAnidulafunginAntifungal AgentsEchinocandinsPyrimidinesTriazolesVoriconazole

Identifiers

PMID23676114
PMCPMC3659089
OpenAlexW2015795983

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.