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Tuberculosis DiagnosisPhase 3NCT03027154

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

A Phase 3 study testing ESAT6-CFP10 in left arm and TB-PPD in right arm and ESAT6-CFP10 in right arm and TB-PPD in left arm in people with Tuberculosis Diagnosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Tuberculosis Diagnosis
What is being tested?
ESAT6-CFP10 in left arm and TB-PPD in right arm and ESAT6-CFP10 in right arm and TB-PPD in left arm
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
4 sitesChina
Study dates
Oct 2016to Mar 2018
Phase
Phase 3
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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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 locations and contacts

4 sites in 1 country.

China4 sites

  • Beijing Children's Hospital

    Beijing

  • Shanghai Public Health Clinical Center

    Shanghai

  • Wuhan Medical Treatment Center

    Wuhan, Hubei

  • Wuhan Institute for Tuberculosis Control

    Wuhan

Other trials in China

About this study

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

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.

Read the 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.

  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.

Being tested
ESAT6-CFP10 in left arm and TB-PPD in right arm, ESAT6-CFP10 in right arm and TB-PPD in left arm
Keywords
diagnostic test, children, diagnosis of tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

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

    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.

Study groups in NCT03027154
Study groupRoleWhat they receive
TB subjects in 5-18 years oldExperimental24 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.
Receives: Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm
non-TB subjects in 5-18 years oldExperimental24 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.
Receives: Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm
TB subjects under 5 years oldExperimental24 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.
Receives: Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm
non-TB subjects under 5 years oldExperimental24 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.
Receives: Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 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.

  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.

    Measured: From injections to 1-3 days after aplication

Secondary outcomes (1)

  1. Number of participants with Adverse Events

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

    Measured: within 72h after injection two drug each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2017
  4. Study completionMar 2018

Resources

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 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03027154
Sponsor's protocol ID
LTao-EC III-children
Status last verified
Oct 2017
First submitted
19 Jan 2017
Last updated
12 Apr 2018
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 10702486

  • 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.

    PubMed 11696195

  • 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.

    PubMed 18431468

  • 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.

    PubMed 17005738

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ESAT6-CFP10 in left arm and TB-PPD in right arm and ESAT6-CFP10 in right arm and TB-PPD in left arm in people with Tuberculosis Diagnosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 4 sites in China.

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 0 inclusion and 19 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 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 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 (time frame: From injections to 1-3 days after aplication). 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 NCT03027154, which also lists 4 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 12 Apr 2018.

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