TuberculosisPhase 2NCT02336542
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
A Phase 2 study testing 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm and 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
Trial summary
96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm and 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2015
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis TB ;
- 18 to 65 years ;
- Consent and signed informed consent forms(ICF) ;
- Comply with follow-up .
Who cannot join
- advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
- Taking part in other clinical or within 3 months involved in any other clinical;
- histories of allergy ;
- in pregnancy or lactation;
- In a mental illness ;
- Any conditions affect the trial evaluation.
Show all 18Show fewer
- Inclusion Criteria of Non-tuberculosis subjects with lung disease :
- Diagnosis non-tuberculosis subjects with lung disease ;
- 18 to 65 years ;
- Consent and signed signed informed consent forms(ICF) ;
- Comply with follow-up .
- Exclusion Criteria of Non-tuberculosis subjects with lung disease :
- advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
- Taking part in other clinical or within 3 months involved in any other clinical;
- histories of allergy;
- in pregnancy or lactation;
- In a mental illness ;
- Any conditions may affect the trial evaluation.
About this study
Official title: For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research
96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.
Read the detailed description
Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods.
- ESAT6-CFP10 （5μg/ml）in left arm；
- ESAT6-CFP10 （5μg/ml）in right arm；
- ESAT6-CFP10 （10μg/ml）in left arm；
- ESAT6-CFP10 （10μg/ml）in right arm； Inject intradermally ESAT6-CFP10 and TB-PPD(tuberculin purified protein derivative ) in different arms of the same subject.For each of the participants in this clinical research, this study uniform that left arm inject a drug(ESAT6-CFP10 or TB - PPD) first, observe 30 min and no no obvious adverse reaction ,then another drug(ESAT6-CFP10 or TB - PPD) inject in right arm. We need draw blood to detect specific γ- IFN before the injection.Observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 96 non-TB subjects with lung disease are divided into different groups and the procedure are as the same as 96 TB subjects above .
Finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the TB patients and non-tuberculosis patients with lung diseases,determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of ESAT6-CFP10 for the clinical auxiliary diagnosis of tuberculosis .
- Conditions
- Tuberculosis
- Being tested
- 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm, 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm
- Keywords
- diagnosis of Tuberculosis, ESAT6, CFP10, skin test, diagnostic test
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological
TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.
5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armBiological
TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.
10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological
TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.
10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armBiological
TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.
| Study group | Role | What they receive |
|---|---|---|
| TB subjects | Experimental | 96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. Receives: Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm; Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm |
| non-TB subjects with lung disease | Active comparator | 96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. Receives: Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm; Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients
we measure the size 15min,24h,48h,72h after administered intradermally ESAT6-CFP10
Measured: within 72h after injection
the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Measured: within 72h after injection
Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Measured: within 72h after injection
The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease
Measured: before administered intradermally
the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Measured: within 72h after injection
Secondary outcomes (4)
the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease
Measured: within 72h after injection two drugs
the consistency between ESAT6-CFP10 and TB-PPD in TB subjects and non-TB subjects with lung disease
Measured: within 72h after injection
the consistency between ESAT6-CFP10 and γ-IFN in TB subjects and non-TB subjects with lung disease
Measured: within 72h after injection
the consistency between TB-PPD and γ-IFN in TB subjects and non-TB subjects with lung disease
Measured: within 72h after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Wuhan Institute for Tuberculosis Control, Proswell Medical Corporation, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Shuihua Lu, Bachelor, Principal investigator, Shanghai Public Health Clinical CenterQi Wu, Master, Principal investigator, Tianjin Haihe HospitalWeihua Wang, Doctor, Principal investigator, Wuhan Insititute for Tuberculosis Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336542
- Sponsor's protocol ID
- LTao-IIb-patient
- Status last verified
- Sep 2015
- First submitted
- 24 Dec 2014
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 10702486Ravn 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.
PubMed 15817755Brusasca 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.
PubMed 11696195Weldingh 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.
PubMed 18431468Aagaard 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.
PubMed 17005738Xu M, Lu W, Li T, Li J, Du W, Wu Q, Liu Q, Yuan B, Lu J, Ding X, Li F, Liu M, Chen B, Pu J, Zhang R, Xi X, Zhou R, Mei Z, Du R, Tao L, Martinez L, Lu S, Wang G, Zhu F. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis. 2022 Mar 1;74(4):668-677. doi: 10.1093/cid/ciab472.
PubMed 34021314
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research
- ClinicalTrials.gov ID
- NCT02336542
- Acronym / sponsor ID
- LTao-IIb-patient
- Conditions
- Tuberculosis
- Keywords
- diagnosis of Tuberculosis, ESAT6, CFP10, skin test, diagnostic test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Wuhan Institute for Tuberculosis Control, Proswell Medical Corporation, Air Force Military Medical University, China
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.
Detailed description
Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods.
- ESAT6-CFP10 （5μg/ml）in left arm；
- ESAT6-CFP10 （5μg/ml）in right arm；
- ESAT6-CFP10 （10μg/ml）in left arm；
- ESAT6-CFP10 （10μg/ml）in right arm； Inject intradermally ESAT6-CFP10 and TB-PPD(tuberculin purified protein derivative ) in different arms of the same subject.For each of the participants in this clinical research, this study uniform that left arm inject a drug(ESAT6-CFP10 or TB - PPD) first, observe 30 min and no no obvious adverse reaction ,then another drug(ESAT6-CFP10 or TB - PPD) inject in right arm. We need draw blood to detect specific γ- IFN before the injection.Observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 96 non-TB subjects with lung disease are divided into different groups and the procedure are as the same as 96 TB subjects above .
Finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the TB patients and non-tuberculosis patients with lung diseases,determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of ESAT6-CFP10 for the clinical auxiliary diagnosis of tuberculosis .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB subjects | Experimental | Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm, Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. |
| non-TB subjects with lung disease | Active comparator | Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm, Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis TB ;
- 18 to 65 years ;
- Consent and signed informed consent forms(ICF) ;
- Comply with follow-up .
Key exclusion criteria (18 listed)
- advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ;
- Taking part in other clinical or within 3 months involved in any other clinical;
- histories of allergy ;
- in pregnancy or lactation;
- In a mental illness ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armTB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm. | Biological | TB subjects, non-TB subjects with lung disease |
| 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armTB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm. | Biological | TB subjects, non-TB subjects with lung disease |
| 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armTB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm. | Biological | TB subjects, non-TB subjects with lung disease |
| 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armTB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm. | Biological | TB subjects, non-TB subjects with lung disease |
Primary outcome
the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients
Time frame: within 72h after injection
we measure the size 15min,24h,48h,72h after administered intradermally ESAT6-CFP10
the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient
Time frame: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases
Time frame: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease
Time frame: before administered intradermally
the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases
Time frame: within 72h after injection
we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
4 secondary outcomes
the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease
Time frame: within 72h after injection two drugs
the consistency between ESAT6-CFP10 and TB-PPD in TB subjects and non-TB subjects with lung disease
Time frame: within 72h after injection
the consistency between ESAT6-CFP10 and γ-IFN in TB subjects and non-TB subjects with lung disease
Time frame: within 72h after injection
the consistency between TB-PPD and γ-IFN in TB subjects and non-TB subjects with lung disease
Time frame: within 72h after injection
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 23 Mar 2017.
- Background: PubMed 10702486van 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.
- Background: PubMed 15817755Ravn 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.
- Background: PubMed 11696195Brusasca 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.
- Background: PubMed 18431468Weldingh 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.
- Background: PubMed 17005738Aagaard 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.
- Derived from this study: PubMed 34021314Xu M, Lu W, Li T, Li J, Du W, Wu Q, Liu Q, Yuan B, Lu J, Ding X, Li F, Liu M, Chen B, Pu J, Zhang R, Xi X, Zhou R, Mei Z, Du R, Tao L, Martinez L, Lu S, Wang G, Zhu F. Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials. Clin Infect Dis. 2022 Mar 1;74(4):668-677. doi: 10.1093/cid/ciab472.
- Center for drug evaluation, CFDA ,ChinaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shuihua Lu, Bachelor principal investigator
Shanghai Public Health Clinical Center
Qi Wu, Master principal investigator
Tianjin Haihe Hospital
Weihua Wang, Doctor principal investigator
Wuhan Insititute for Tuberculosis Control
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm and 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
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 4 inclusion and 18 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients (time frame: within 72h after injection). The study lists 5 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 NCT02336542, which also lists 6 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 23 Mar 2017.