Evidence map›Paper›PMID 38105213›Full record

ArticleTrials2023

Efficacy and safety of voriconazole in the treatment of invasive pulmonary aspergillosis in patients with liver failure: study protocol for a randomized controlled clinical trial.

Xue Yu, Lejia Xu, Jiaxing Zheng, Ziying Lei, Yihua Pang, Xiaojie Li, Jianyun Zhu, Jing Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

8 authors at 1 institution in 1 country.

Xue Yu *Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Lejia Xu *Department of Pharmacy, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Jiaxing ZhengDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Ziying LeiDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Yihua PangDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Xiaojie LiDepartment of Laboratory Medicine, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China.
Jianyun ZhuDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China. 13719366255@139.com.
Jing LiuDepartment of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe RoadGuangdong Province, Guangzhou City, 510630, China. liuj26@mail.sysu.edu.cn.ORCID http://orcid.org/0000-0001-7718-4344
Sun Yat-sen University · CN

Funding

China International Medical Foundation Z-2018-35-2002Clinical Research Foundation of third Affiliated Hospital of Sun Yat-sen University YHJH201904
6 · The paper itself

Abstract

backgroundAcute-on-chronic liver failure (ACLF) is a common clinical type of liver failure, and patients with acute-on-chronic liver failure are prone to fungal infections, especially the increasing incidence of invasive pulmonary aspergillosis (IPA). Voriconazole is recommended as the first-line antifungal agent in the treatment of invasive aspergillosis; however, no recommendation has been given for patients with severe liver cirrhosis (Child-Pugh C) and liver failure. This trial aims to examine the therapeutic effects and safety of voriconazole in the treatment of IPA in patients with liver failure.

methodsThis study is a non-double-blind randomized controlled trial. The 96 eligible acute-on-chronic liver failure patients complicated with invasive pulmonary aspergillosis will be randomly assigned to receive either the optimized voriconazole regimen or the recommended voriconazole regimen for patients with mild to moderate liver cirrhosis (Child-Pugh A and B), at a 1:1 ratio, with an 8-week follow-up period. The antifungal efficacy of voriconazole will be the primary outcome measure. Plasma voriconazole trough concentration, the laboratory examination (CRP, PCT, ESR, etc.), chest CT, adverse events, and mortality at week 4 and 8 will be the secondary outcome measures. DISCUSSION: This trial aims to demonstrate the efficacy and safety of voriconazole in the treatment of IPA in patients with liver failure, which is expected to provide a reference for scientific optimization of voriconazole regimens and a realistic basis for the standardized treatment of acute-on-chronic liver failure patients complicated with invasive pulmonary aspergillosis.

trial registrationThe trial was registered with the Chinese Clinical Trial Registry, ChiCTR2100048259. Registered on 5 July 2021.

Indexed as

Acute-On-Chronic Liver FailureInvasive Pulmonary AspergillosisAntifungal AgentsHumansLiver CirrhosisRandomized Controlled Trials as TopicTreatment OutcomeVoriconazoleAntifungal AgentsVoriconazoleAcute-on-chronic liver failureInvasive pulmonary aspergillosisStudy protocolVoriconazole

Identifiers

PMID38105213
PMCPMC10726598
OpenAlexW4389857035

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.