Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children
For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 Dose Certain Phase III Clinical Research in Children Under the Age of 18 Years Old
1 other identifier
interventional
96
1 country
4
Brief Summary
In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases non-TB participants with lung disease 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 in order to assess the safety of drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 12, 2018
October 1, 2017
1 year
January 19, 2017
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The diameter of induration or redness at the injection sites measured transversely to the long axis of the forearm 24 hours、48 hours and 72 hours after application of the agents
After skin test 1-3d,subjects's injection site may appear inuration or redness .The diameters of induration or redness are measured and recorded.The number of diameter of induration or redness\<5mm，the result is negtive.If the number of diameter are not lower than 5mm,the result is positive.
From injections to 1-3 days after aplication
Secondary Outcomes (1)
Number of participants with Adverse Events
within 72h after injection two drug each participant
Study Arms (4)
TB subjects in 5-18 years old
EXPERIMENTAL24 cases TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 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.
non-TB subjects in 5-18 years old
EXPERIMENTAL24 cases non-TB subjects in 5-18 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 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.
TB subjects under 5 years old
EXPERIMENTAL24 cases TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 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.
non-TB subjects under 5 years old
EXPERIMENTAL24 cases non-TB subjects under 5 years old are injected ESAT6-CFP10 in left arm and TB-PPD in right arm or ESAT6-CFP10 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.
Interventions
All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
Eligibility Criteria
You may qualify if:
- judge the pulmonary tuberculosis patient ,according to Chinese Medical Association branch of pediatrics breathing group: Tuberculosis Clinical Diagnostic Criteria and Treatment Programs for Child (trial) ;
- less than 18 years old ,no gender limited;
- Consent and signed informed consent forms (ICF) by the subject or the guardian;
- The subject or with the help of guardian(s) 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;
You may not qualify if:
- Accompanied by the following severe illness: cancer, acute/progressive liver disease or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases, other chronic diseases;
- Taking part in other clinical or within three months involved in any other clinical;
- Severe allergic constitution or familial history of allergy:allergic to two or more drugs;
- in pregnancy or lactation;
- in a mental illness;
- Any conditions affect the trial evaluation by investigator's judgement.
- A clear respiratory disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
- less than 18 years old ,no gender limited;
- Consent and signed informed consent forms (ICF) by the subject or the guardian;
- The subject or with the help of guardian(s) comply with follow-up.
- Accompanied by the following severe illness: cancer, acute/progressive liver disease or kidney disease,autoimmune disease，diabetes, primary immunodeficiency diseases, other chronic diseases， ect;
- Taking part in other clinical or within three months involved in any other clinical;
- Severe allergic constitution or familial history of allergy: allergic to two or more drugs;
- in pregnancy or lactation;
- in a mental illness;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Wuhan Medical Treatment Center
Wuhan, Hubei, China
Beijing Children's Hospital
Beijing, China
Shanghai Public Health Clinical Center
Shanghai, China
Wuhan Institute for Tuberculosis Control
Wuhan, China
Related Publications (4)
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.
PMID: 10702486BACKGROUNDBrusasca 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.
PMID: 11696195BACKGROUNDWeldingh 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.
PMID: 18431468BACKGROUNDAagaard 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.
PMID: 17005738BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Shuihua Lu, BBachelor
Shanghai Public Health Clinical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2017
First Posted
January 23, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
March 1, 2018
Last Updated
April 12, 2018
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share