Evidence map›Paper›PMID 36221062›Full record

Trial reportBMC infectious diseases2022

Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study.

Yang Yang, Zhixiong Fang, Wei Huang, Haiming Zhang, Si Luo, Sha Lin, Shaojie Li, Shuihua Lu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 25% 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, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. A Systematic Review on the Safety ofOpen forum infectious diseases · 2023
    Article
  5. Article
  6. 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 5 institutions in 1 country.

Yang Yang *Shanghai Public Health Clinical Center Affiliated to Fudan University, 201508, Shanghai, China.
Zhixiong Fang *Department of Infectious Disease and Public Health, Central Hospital of Xiangtan, Xiangtan, Hunan province, China.
Wei HuangShanghai Public Health Clinical Center Affiliated to Fudan University, 201508, Shanghai, China.
Haiming ZhangDepartment of Infectious Disease and Public Health, Central Hospital of Xiangtan, Xiangtan, Hunan province, China.
Si LuoXiangtan Center for Disease Control and Prevention, Xiangtan, Hunan province, China.
Sha LinDepartment of Infectious Disease and Public Health, Central Hospital of Xiangtan, Xiangtan, Hunan province, China.
Shaojie LiDepartment of General Surgery, Xiangtan First People's Hospital, Xiangtan, Hunan province, China. 283729027@qq.com.
Shuihua LuDepartment of Pulmonary Medicine, The Second Affiliated Hospital, School of Medicine, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Southern University of Science and Technology, 518112, Shenzhen, Guangdong Province, China. lushuihua66@126.com.
Xiangyang Central Hospital · CNShanghai Public Health Clinical Center · CNShenzhen Third People’s Hospital · CNXiangtan University · CNXiang Yang No.1 People's Hospital · CN

Funding

Grants from Hunan Provincial Health Commission 20200855Grants from Shanghai Public Health Clinical Center KY-GW-2021-21National Natural Science Foundation of China 81770014Shanghai Clinical key specialist Construction Project (Tuberculosis) shslczdzk03002
6 · The paper itself

Abstract

backgroundESAT6-CFP10 (EC) skin test has been reported accurate and safe in identifying tuberculosis infection. We aimed to demonstrate the safety of EC skin test compared with tuberculin skin test (TST) in university freshmen.

methodsWe conducted a double-blind, randomized, controlled clinical study in a university freshmen population with 16,680 participates in China, and finally 14,579 completed the study. About a half received an EC skin test and the others received TST. Adverse reactions were evaluated.

resultsOut of the 14,579 participants, 48.2% (7029/14,579) were males. The average age was 18.1 ± 0.8 years and the average BMI was 20.9 ± 3.1 kg/m

conclusionthe EC skin test was safe in our cohort. And its incidence of total adverse drug reactions (ADRs) is less than that of TST. Most adverse reactions were mild or moderate, lasting less than 48 h and self-limiting. Considering the satisfactory diagnostic accuracy in identifying tuberculosis infection, the cost and safety, the EC skin test might be a potential candidate for replacing TST in high burden countries or those with routine BCG vaccination. CLINICAL TRIALS REGISTRATION: ChiCTR2000038622, Safety of the EC skin test to screen tuberculosis infection in two universities, compared with the tuberculin skin test: a double-blind, randomized, controlled trial. registered on 26/09/2020 at http://www.chictr.org.cn .

Indexed as

Latent TuberculosisTuberculosisAdolescentBCG VaccineDouble-Blind MethodFemaleHumansMaleTuberculin TestVaccinationBCG VaccineESAT6-CFP10SafetyTuberculin skin testTuberculosis

Identifiers

PMID36221062
PMCPMC9552410
OpenAlexW4304187453

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.