NCT02623556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,090

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 12, 2018

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

December 3, 2015

Last Update Submit

April 10, 2018

Conditions

Tuberculosis

Keywords

diagnosis of tuberculosisESAT6-CFP10skin testdiagnostic test

Outcome Measures

Primary Outcomes (4)

  • 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)

    within 72h after injection

  • 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)

    within 72h after injection

  • 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)

    within 72h after injection

  • 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)

    within 72h after injection

Secondary Outcomes (1)

  • Number of participants with Adverse Events

    within 72h after injection two drug each participant

Study Arms (2)

TB subjects

EXPERIMENTAL

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.

Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armBiological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm

non-TB subjects with lung disease and suspected TB subjects

EXPERIMENTAL

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.

Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armBiological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm

Interventions

ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armBIOLOGICAL

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.

TB subjectsnon-TB subjects with lung disease and suspected TB subjects
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left armBIOLOGICAL

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.

TB subjectsnon-TB subjects with lung disease and suspected TB subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic Criteria for pulmonary tuberculosis;
  • to 65 years old ,no gender limited;
  • Consent and signed informed consent forms (ICF);
  • 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: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.
  • A clear lung disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
  • to 65 years old, no gender limited;
  • Consent and signed informed consent forms (ICF);
  • Comply with follow-up.
  • 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;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wuxi NO.5 People's Hospital

Wuxi, Jiangsu, China

Location

Shanghai Public Health clinical Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

  • 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: 10702486BACKGROUND

  • 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.

    PMID: 15817755BACKGROUND

  • 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.

    PMID: 11696195BACKGROUND

  • 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.

    PMID: 18431468BACKGROUND

  • 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.

    PMID: 17005738BACKGROUND

Related Links

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Shuihua Lu, Bachelor

    Shanghai Public Health Clinical Center

    PRINCIPAL INVESTIGATOR

  • Qi Wu, Master

    Tianjin Haihe Hospital

    PRINCIPAL INVESTIGATOR

  • Weihua Wang, Doctor

    Wuhan Institute for Tuberculosis Control

    PRINCIPAL INVESTIGATOR

  • Naihui Chu, Bachelor

    Beijing Chest Hospital

    PRINCIPAL INVESTIGATOR

  • Qinfang Ou

    Wuxi No.5 People's Hospital

    PRINCIPAL INVESTIGATOR

  • Youlun Li, Doctor

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Xiaohong Chen

    Fuzhou Pulmonary Hospital of fujuan

    PRINCIPAL INVESTIGATOR

  • Hongqiu Pan

    Zhenjiang Third People's Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaodong Mei, Doctor

    Anhui Provincial Hospital

    PRINCIPAL INVESTIGATOR

  • Qunyi Deng, Doctor

    Shenzhen Third People's Hospital

    PRINCIPAL INVESTIGATOR

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

December 3, 2015

First Posted

December 7, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 12, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)