Back to resultsClinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
Primary Purpose
Tuberculosis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring diagnosis of tuberculosis, ESAT6-CFP10, skin test, diagnostic test
Eligibility Criteria
Inclusion Criteria of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects:
- judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic Criteria for pulmonary tuberculosis;
- 18 to 65 years old ,no gender limited;
- Consent and signed informed consent forms (ICF);
- Comply with follow-up.
Inclusion Criteria of extra pulmonary tuberculosis subjects:
- 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;
Exclusion Criteria of TB (tuberculosis) subjects:
- 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;
- Any conditions affect the trial evaluation by investigator's judgement.
Inclusion Criteria of non-TB participants with lung disease:
- 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.
Exclusion Criteria of non-TB participants with lung disease:
- 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.
Inclusion Criteria of suspected TB participants with lung disease:
- 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 of suspected TB participants with lung disease:
- 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.
Sites / Locations
- Wuxi NO.5 People's Hospital
- Shanghai Public Health clinical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TB subjects
non-TB subjects with lung disease and suspected TB subjects
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Secondary Outcome Measures
Number of participants with Adverse Events
Full Information
NCT ID
NCT02623556
First Posted
December 3, 2015
Last Updated
April 10, 2018
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Air Force Military Medical University, China, Proswell Medical Corporation, Wuhan Institute for Tuberculosis Control, Beijing Chest Hospital, Wuxi Hospital for Infectious Diseases, First Affiliated Hospital of Chongqing Medical University, Fuzhou Pulmonary Hospital of Fujian, Zhenjiang Third People's Hospital, Anhui Provincial Hospital, Shenzhen Third People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02623556
Brief Title
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
Official Title
For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Air Force Military Medical University, China, Proswell Medical Corporation, Wuhan Institute for Tuberculosis Control, Beijing Chest Hospital, Wuxi Hospital for Infectious Diseases, First Affiliated Hospital of Chongqing Medical University, Fuzhou Pulmonary Hospital of Fujian, Zhenjiang Third People's Hospital, Anhui Provincial Hospital, Shenzhen Third People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.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 all kind of adverse events.
Detailed Description
Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are divided into different groups through a randomized and blind method.
ESAT6-CFP10(10ug/ml) in left arm
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
diagnosis of tuberculosis, ESAT6-CFP10, skin test, diagnostic test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1090 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TB subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
non-TB subjects with lung disease and suspected TB subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
Description
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Time Frame
within 72h after injection
Title
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
Description
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Time Frame
within 72h after injection
Title
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
Description
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Time Frame
within 72h after injection
Title
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
Description
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Time Frame
within 72h after injection
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
within 72h after injection two drug each participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects:
judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic Criteria for pulmonary tuberculosis;
18 to 65 years old ,no gender limited;
Consent and signed informed consent forms (ICF);
Comply with follow-up.
Inclusion Criteria of extra pulmonary tuberculosis subjects:
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;
Exclusion Criteria of TB (tuberculosis) subjects:
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;
Any conditions affect the trial evaluation by investigator's judgement.
Inclusion Criteria of non-TB participants with lung disease:
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.
Exclusion Criteria of non-TB participants with lung disease:
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.
Inclusion Criteria of suspected TB participants with lung disease:
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 of suspected TB participants with lung disease:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuihua Lu, Bachelor
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qi Wu, Master
Organizational Affiliation
Tianjin Haihe Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weihua Wang, Doctor
Organizational Affiliation
Wuhan Institute for Tuberculosis Control
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naihui Chu, Bachelor
Organizational Affiliation
Beijing Chest Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinfang Ou
Organizational Affiliation
Wuxi No.5 People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youlun Li, Doctor
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaohong Chen
Organizational Affiliation
Fuzhou Pulmonary Hospital of fujuan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongqiu Pan
Organizational Affiliation
Zhenjiang Third People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaodong Mei, Doctor
Organizational Affiliation
Anhui Provincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qunyi Deng, Doctor
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuxi NO.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Shanghai Public Health clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10702486
Citation
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.
Results Reference
background
PubMed Identifier
15817755
Citation
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.
Results Reference
background
PubMed Identifier
11696195
Citation
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.
Results Reference
background
PubMed Identifier
18431468
Citation
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.
Results Reference
background
PubMed Identifier
17005738
Citation
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.
Results Reference
background
Links:
URL
http://www.cde.org.cn/
Description
Center for drug evaluation, CFDA, China
URL
http://www.chinadrugtrials.org.cn/
Description
Chinese Clinical Trial Registry
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Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
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