Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children

Anhui Zhifei Longcom

Status and phase: Completed; Phase 3

Conditions: Tuberculosis Diagnosis

Treatments: Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03027154

LTao-EC III-children

Details and patient eligibility

About

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.

Full description

In this clinical research,we make sure of the safety in the crowd 5-18 years old firstly,then carry out the crowd of under 5 years old(including 5).

Firstly, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung disease who are all 5-18 years old and meet the standard respectively are divided into different groups through a randomized and blind method.

1. ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm
2. ESAT6-CFP10(10ug/ml) in right arm and TB-PPD in left 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, 24 cases TB (Tuberculosis) participants and 24 cases non-TB participants with lung disease who are all less than 5 years old are divided into two different groups and the procedure are as the same as 5-18 years old.

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.

Enrollment: 96 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects:

• 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.

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: 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.

Inclusion Criteria of non-TB participants with lung disease:

• 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.

Exclusion Criteria of non-TB participants with lung disease:

• 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;
• active tuberculosis close contactor;
• Any conditions affect the trial evaluation by investigator's judgement.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 4 patient groups

TB subjects in 5-18 years old

Experimental group

Description:

24 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.

Treatment:

Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm

Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm

non-TB subjects in 5-18 years old

Experimental group

Description:

24 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.

Treatment:

Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm

Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm

TB subjects under 5 years old

Experimental group

Description:

24 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.

Treatment:

Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm

Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm

non-TB subjects under 5 years old

Experimental group

Description:

24 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.

Treatment:

Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm

Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm