Tuberculosis; Pulmonary, Confirmed, Unspecified MeansNCT04434976
Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
An observational study of Tuberculosis; Pulmonary, Confirmed, Unspecified Means, run by Huashan Hospital at 20 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis; Pulmonary, Confirmed, Unspecified Means
- How many people
- 400 participants
- Where
- 20 sitesChina
- Study dates
- 8 Sep 2019to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Bacteriological positive: including positive AFB smear/ culture / molecular test;
- Agree to accept this survey;
Who cannot join
- 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;
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Beihai Tuberculosis Hospital
Beihai, Guangxi
Changchun Infectious Diseases Hospital
Changchun, Jilin
The 2th Hospital of Daqing
Daqing, Hei Longjiang
Guiyang Public Health Clinical Center
Guiyang, Guizhou
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang
Anhui Province Hospital
Hefei, Anhui
The First People's Hospital of Huaihua
Huaihua, Hunan
Shandong Province Chest hospital
Jinan, Shandong
Qiubei People's Hospital
Jinping, Yunnan
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan
Jiangxi Province Chest Hospital
Nanchang, Jiangxi
905th Hospital of PLA Navy
Shanghai, Shanghai Municipality
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong
The First People's Hospital of Taicang
Taicang, Jiangsu
Wenzhou Central Hospital
Wenzhou, Zhejiang
Wuhan Medical Treatment Center
Wuhan, Hubei
Xian Chest Hospital
Xian, Shanxi
Xuzhou Infectious Diseases Hospital Huimei Liu
Xuzhou, Jiangsu
Henan Province Infectious Diseases Hospital
Zhengzhou, Henan
About this study
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).
Read the 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.
- Keywords
- bacteriologically confirmed pulmonary tuberculosis, health-seeking pathways, Delayed Diagnosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delayed diagnosis | 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. | |
| undelayed diagnosis | The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median time of pulmonary tuberculosis diagnosis confirmed
Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories. According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
Secondary outcomes (4)
Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
According to the patients' health-seeking pathways, calculate the test coverage rates including anti fast bacteria smear, tuberculosis culture, and GeneXpert in different clinical institutions. The test coverage rates is acquired by recording the laboratory test reports in medical systems or paper version from patients.
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
We collect the fluoroquinolones use evidence of each patients in different clinical institutions by asking the past medical histories and reviewing paper reports from patients as well as medical system. Then use logistic correlation to find the relation between the fluoroquinolones use history and the diagnosis delay of the pulmonary tuberculosis.
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
Calculating the distribution of patients' sociodemographic characteristics and correlation between results above and pulmonary tuberculosis diagnosis delay. Patients' sociodemographic characteristics includes: age, sex, marriage status, nation, occupation, education status, annual family income per capita, underlying disease such as diabetes, habits of smoking and habits of drinking alcohol.
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
According to the past medical history of each pulmonary tuberculosis diagnosis confirmed patients, we collect their onset symptoms and calculate the rate respectively. Then use logistic correlation to find the relation between the onset symptoms and the diagnosis delay of the pulmonary tuberculosis.
Measured: immediately after asking the medical history and collecting the result of TB diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start8 Sep 2019
- Primary completion2 Nov 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis; Pulmonary, Confirmed, Unspecified MeansStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, PHD, Principal investigator, Huashan Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434976
- Sponsor's protocol ID
- KY-2019TB-20
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We would like to share the study protocol and statistical analysis plan.
Publications
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.
PubMed 31693941Martinez 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.
PubMed 28193742Hogan 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.
PubMed 31723692Storla 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.
PubMed 18194573Hanson 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.
PubMed 29117350Hanson 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.
PubMed 29117351Farhat 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.
PubMed 29017248Lewinsohn 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.
PubMed 28052967GBD 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.
PubMed 30507459Mijiti 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.
PubMed 27283762
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
- ClinicalTrials.gov ID
- NCT04434976
- Acronym / sponsor ID
- KY-2019TB-20
- Keywords
- bacteriologically confirmed pulmonary tuberculosis, health-seeking pathways, Delayed Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed diagnosis | – | –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. |
| undelayed diagnosis | – | –The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Bacteriological positive: including positive AFB smear/ culture / molecular test;
- Agree to accept this survey;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The median time of pulmonary tuberculosis diagnosis confirmed
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed
The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories. According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.
4 secondary outcomes
Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
Time frame: immediately after asking the medical history and collecting the result of TB diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Results publication: PubMed 31693941Liu 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.
- Results publication: PubMed 28193742Martinez 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.
- Results publication: PubMed 31723692Hogan 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.
- Results publication: PubMed 18194573Storla 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.
- Results publication: PubMed 29117350Hanson 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.
- Results publication: PubMed 29117351Hanson 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.
- Results publication: PubMed 29017248Farhat 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.
- Results publication: PubMed 28052967Lewinsohn 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.
- Results publication: PubMed 30507459GBD 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.
- Results publication: PubMed 27283762Mijiti 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.
- Individual participant dataSharing planned: Yes. We would like to share the study protocol and statistical analysis plan.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhong Zhang, PHD principal investigator
Huashan Hospita
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis; Pulmonary, Confirmed, Unspecified Means, run by Huashan Hospital at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median time of pulmonary tuberculosis diagnosis confirmed (time frame: immediately after asking the medical history and collecting the result of TB diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434976, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.