Clinical trial NCT04434976: Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
Official title: Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis; Pulmonary, Confirmed, Unspecified Means
Keywords: bacteriologically confirmed pulmonary tuberculosis
health-seeking pathways
Delayed Diagnosis
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study, 400 patients with bacteriologically confirmed pulmonary tuberculosis(TB) were chose from 20 hospitals, each hospital select 20 patients according to the eligibility criteria randomly. These 20 TB-designated medical institutions are covering the eastern region (7), the central region (8) and the western region (5) among China.

Brief summary: The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

Detailed description: This research is a retrospective, multicenter, case-control study. The purpose of this study is to collect and assess health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

According to inclusion criteria and exclusion criteria, a total of 400 participants with bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated medical institutions will be conducted in depth, covering the eastern region (7), the central region (8) and the western region (5), each hospital will enroll 20 eligible patients on the basis of convenience.

The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined if The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. By offline or online interview, we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway, including: hospital name, the date of each visit, laboratory tests and radiology evaluation results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of previous consultations and trace their classification through the official website of the Health and Medical Commission. Determine whether these hospital are designated institution based on the CDC's publicity. Consult the laboratory facilities by phone.

The primary objective is to gain the median time of pulmonary tuberculosis diagnosis confirmed and the correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis.

The secondary objective is to gain the bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.

Eligibility criteria: Inclusion Criteria:

* Bacteriological positive: including positive AFB smear/ culture / molecular test;
* Agree to accept this survey;

Exclusion Criteria:

* HIV antibody positive and AIDS patients;
* Combined with extrapulmonary TB;
* Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;

Primary outcomes:
measure: The median time of pulmonary tuberculosis diagnosis confirmed
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
measure: The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
Secondary outcomes:
measure: Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
measure: The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
measure: The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
measure: The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
timeFrame: immediately after asking the medical history and collecting the result of TB diagnosis
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Province Hospital
state: Anhui
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
state: Guangdong
city: Beihai
country: China
facility: Beihai Tuberculosis Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guiyang Public Health Clinical Center
state: Guizhou
city: Daqing
country: China
facility: The 2th Hospital of Daqing
state: Hei Longjiang
city: Zhengzhou
country: China
facility: Henan Province Infectious Diseases Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Medical Treatment Center
state: Hubei
city: Huaihua
country: China
facility: The First People's Hospital of Huaihua
state: Hunan
city: Taicang
country: China
facility: The First People's Hospital of Taicang
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Infectious Diseases Hospital Huimei Liu
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Province Chest Hospital
state: Jiangxi
city: Changchun
country: China
facility: Changchun Infectious Diseases Hospital
state: Jilin
city: Jinan
country: China
facility: Shandong Province Chest hospital
state: Shandong
city: Shanghai
country: China
facility: 905th Hospital of PLA Navy
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Xian
country: China
facility: Xian Chest Hospital
state: Shanxi
city: Luzhou
country: China
facility: Southwest Medical University Affiliated Hospital
state: Sichuan
city: Qiubei
country: China
facility: Qiubei People's Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Red Cross Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Huashan Hospita
name: Wenhong Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu R, Li J, Tan Y, Shang Y, Li Y, Su B, Shu W, Pang Y, Gao M, Ma L. Multicenter evaluation of the acid-fast bacillus smear, mycobacterial culture, Xpert MTB/RIF assay, and adenosine deaminase for the diagnosis of tuberculous peritonitis in China. Int J Infect Dis. 2020 Jan;90:119-124. doi: 10.1016/j.ijid.2019.10.036. Epub 2019 Nov 4.
citation: Martinez L, Xu L, Chen C, Sekandi JN, Zhu Y, Zhang C, Whalen CC, Zhu L. Delays and Pathways to Final Tuberculosis Diagnosis in Patients from a Referral Hospital in Urban China. Am J Trop Med Hyg. 2017 May;96(5):1060-1065. doi: 10.4269/ajtmh.16-0358. Epub 2017 Feb 13.
citation: Hogan CA, Puri L, Gore G, Pai M. Impact of fluoroquinolone treatment on delay of tuberculosis diagnosis: A systematic review and meta-analysis. J Clin Tuberc Other Mycobact Dis. 2016 Dec 13;6:1-7. doi: 10.1016/j.jctube.2016.12.001. eCollection 2017 Jan.
citation: Storla DG, Yimer S, Bjune GA. A systematic review of delay in the diagnosis and treatment of tuberculosis. BMC Public Health. 2008 Jan 14;8:15. doi: 10.1186/1471-2458-8-15.
citation: Hanson CL, Osberg M, Brown J, Durham G, Chin DP. Conducting Patient-Pathway Analysis to Inform Programming of Tuberculosis Services: Methods. J Infect Dis. 2017 Nov 6;216(suppl_7):S679-S685. doi: 10.1093/infdis/jix387.
citation: Hanson C, Osberg M, Brown J, Durham G, Chin DP. Finding the Missing Patients With Tuberculosis: Lessons Learned From Patient-Pathway Analyses in 5 Countries. J Infect Dis. 2017 Nov 6;216(suppl_7):S686-S695. doi: 10.1093/infdis/jix388.
citation: Farhat MR, Jacobson KR, Franke MF, Kaur D, Murray M, Mitnick CD. Fluoroquinolone Resistance Mutation Detection Is Equivalent to Culture-Based Drug Sensitivity Testing for Predicting Multidrug-Resistant Tuberculosis Treatment Outcome: A Retrospective Cohort Study. Clin Infect Dis. 2017 Oct 15;65(8):1364-1370. doi: 10.1093/cid/cix556.
citation: Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH, O'Brien RJ, Pai M, Richeldi L, Salfinger M, Shinnick TM, Sterling TR, Warshauer DM, Woods GL. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017 Jan 15;64(2):111-115. doi: 10.1093/cid/ciw778.
citation: GBD Tuberculosis Collaborators. Global, regional, and national burden of tuberculosis, 1990-2016: results from the Global Burden of Diseases, Injuries, and Risk Factors 2016 Study. Lancet Infect Dis. 2018 Dec;18(12):1329-1349. doi: 10.1016/S1473-3099(18)30625-X.
citation: Mijiti P, Yuehua L, Feng X, Milligan PJ, Merle C, Gang W, Nianqiang L, Upur H. Prevalence of pulmonary tuberculosis in western China in 2010-11: a population-based, cross-sectional survey. Lancet Glob Health. 2016 Jul;4(7):e485-94. doi: 10.1016/S2214-109X(16)30074-2. Epub 2016 Jun 6.