Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
NCT ID: NCT02623556
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1090 participants
INTERVENTIONAL
2015-12-31
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
NCT02336542
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
NCT02329730
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
NCT02389322
Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)
NCT02795260
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children
NCT03027154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. ESAT6-CFP10(10ug/ml) in left arm
2. ESAT6-CFP10(10ug/ml) in right arm. Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 360 cases non-TB participants with lung disease and suspected TB participants are divided into two different groups and the procedure are as the same as 720 cases TB.
Thirdly,suspected TB participants are put under TB (Tuberculosis patients) or non-TB participants with lung disease by diagnosis when out group.
Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis patients), the specificity (negative coincidence rate) by non-TB participants with lung disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical auxiliary diagnosis of tuberculosis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TB subjects
720 cases TB (Tuberculosis) subjects who meet the standard respectively are divided average into two groups through a randomized and blind method.
360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
non-TB subjects with lung disease and suspected TB subjects
360 cases non-TB subjects with lung disease and suspected TB subjects,who meet the standard respectively are divided average into different groups through a randomized and blind method. 180 non-TB subjects with lung disease are injected ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm. 180 non-TB subjects with lung disease are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. The study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 to 65 years old ,no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
* Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on;
* Lesions outside the lungs;
* be in unfinished reinforced phase by chemotherapy;
* A clear lung disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
* 18 to 65 years old, no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
* Cases who have pulmonary tuberculosis by clinical symptoms/signs:appear cough、cough with hemoptysis、pectoralgia、dyspnea、fever（low-grade fever at afternoon）,together with night sweats、weak、loss of appetite、weight loss,and so on,or other easily-confused respiratory system disease with TB;
* 18 to 65 years old, no gender limited;
* Consent and signed informed consent forms (ICF);
* Comply with follow-up.
Exclusion Criteria
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution:allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* Any conditions affect the trial evaluation by investigator's judgement.
* Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution: allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* history of tuberculosis;
* Any conditions affect the trial evaluation by investigator's judgement.
* Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
* Taking part in other clinical or within three months involved in any other clinical;
* Severe allergic constitution: allergic to two or more drugs;
* in pregnancy or lactation;
* in a mental illness;
* history of tuberculosis;
* Any conditions affect the trial evaluation by investigator's judgement.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Public Health Clinical Center
OTHER_GOV
Tianjin Haihe Hospital
OTHER
Air Force Military Medical University, China
OTHER
Proswell Medical Corporation
INDUSTRY
Wuhan Institute for Tuberculosis Control
OTHER
Beijing Chest Hospital
OTHER
Wuxi Hospital for Infectious Diseases
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Fuzhou Pulmonary Hospital of Fujian
OTHER
Zhenjiang Third People's Hospital
UNKNOWN
Anhui Provincial Hospital
OTHER_GOV
Shenzhen Third People's Hospital
OTHER
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shuihua Lu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Public Health Clinical Center
Qi Wu, Master
Role: PRINCIPAL_INVESTIGATOR
Tianjin Haihe Hospital
Weihua Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Wuhan Institute for Tuberculosis Control
Naihui Chu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Beijing Chest Hospital
Qinfang Ou
Role: PRINCIPAL_INVESTIGATOR
Wuxi No.5 People's Hospital
Youlun Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Xiaohong Chen
Role: PRINCIPAL_INVESTIGATOR
Fuzhou Pulmonary Hospital of fujuan
Hongqiu Pan
Role: PRINCIPAL_INVESTIGATOR
Zhenjiang Third People's Hospital
Xiaodong Mei, Doctor
Role: PRINCIPAL_INVESTIGATOR
Anhui Provincial Hospital
Qunyi Deng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Third People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wuxi NO.5 People's Hospital
Wuxi, Jiangsu, China
Shanghai Public Health clinical Center
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.
Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005.
Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.
Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.
Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.
Related Links
Access external resources that provide additional context or updates about the study.
Center for drug evaluation, CFDA, China
Chinese Clinical Trial Registry
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LTao-EC III-patient
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.