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

Primary Purpose

Tuberculosis Diagnosis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional diagnostic trial for Tuberculosis Diagnosis focused on measuring diagnostic test, children, diagnosis of tuberculosis

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wuhan Medical Treatment Center
Beijing Children's Hospital
Shanghai Public Health Clinical Center
Wuhan Institute for Tuberculosis Control

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

TB subjects in 5-18 years old

non-TB subjects in 5-18 years old

TB subjects under 5 years old

non-TB subjects under 5 years old

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with Adverse Events

Any AE of every subject appeared is recorded and traced after signing ICF,until remission of AE.

Full Information

NCT ID

NCT03027154

First Posted

January 19, 2017

Last Updated

April 10, 2018

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Collaborators

Shanghai Public Health Clinical Center, Beijing Children's Hospital, Wuhan Institute for Tuberculosis Control, Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT03027154

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

October 2017 (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, Beijing Children's Hospital, Wuhan Institute for Tuberculosis Control, Wuhan Union Hospital, China

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis Diagnosis

Keywords

diagnostic test, children, diagnosis of tuberculosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TB subjects in 5-18 years old

Arm Type

Experimental

Arm Description

Arm Title

non-TB subjects in 5-18 years old

Arm Type

Experimental

Arm Description

Arm Title

TB subjects under 5 years old

Arm Type

Experimental

Arm Description

Arm Title

non-TB subjects under 5 years old

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From injections to 1-3 days after aplication

Secondary Outcome Measure Information:

Title

Number of participants with Adverse Events

Description

Any AE of every subject appeared is recorded and traced after signing ICF,until remission of AE.

Time Frame

within 72h after injection two drug each participant

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuihua Lu, BBachelor

Organizational Affiliation

Shanghai Public Health Clinical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wuhan Medical Treatment Center

City

Wuhan

State/Province

Hubei

Country

China

Facility Name

Beijing Children's Hospital

City

Beijing

Country

China

Facility Name

Shanghai Public Health Clinical Center

City

Shanghai

Country

China

Facility Name

Wuhan Institute for Tuberculosis Control

City

Wuhan

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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

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

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