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A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis (TESEC-02)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
rdESAT-6 + rCFP-10 (C-Tb)
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring tuberculosis, ESAT-6, CFP-10, skin test, diagnostic test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient:

  1. Has signed an informed consent
  2. Is willing and likely to comply with the trial procedures

  3. Has been diagnosed with active TB and has been in treatment ≤ 60 days at the time of inclusion

    • has 1 documented positive sputum smear microscopy result
    • has positive culture
    • has a positive PCR result for tuberculosis
    • has a compatible clinical picture of TB with the intention to treat
  4. Has a positive T-spot assay or a QuantiFERON®-TB Gold In Tube test
  5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

The patient:

  1. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
  2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. BCG, MMR, yellow fever, oral typhoid vaccines)
  3. Has a known congenital or acquired immune deficiency
  4. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  5. Is infected with HIV
  6. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
  7. Has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  8. Is actively participating in another clinical trial
  9. Is pregnant according to urine pregnancy test at inclusion
  10. Has a condition which in the opinion of the investigator is not suitable for participation in the study

Sites / Locations

  • St George's University of London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0.01µg C-Tb

0.1µg C.Tb

Arm Description

12-24 patients depending on a safety evaluation will receive a low dose of 0.01 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.

12-24 patients depending on a safety evaluation will receive a high dose of 0.1 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.

Outcomes

Primary Outcome Measures

Local and systemic adverse reactions at the injection sites within 28 days after application of the tests (0.01/0.1 µg C-Tb).

Secondary Outcome Measures

Immune response of 2 doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration; the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol and the pain associated with the injection of unpreserved C-Tb and preserved C-Tb

Full Information

First Posted
December 16, 2009
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT01033929
Brief Title
A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis
Acronym
TESEC-02
Official Title
A Safety and Dose Finding Trial of the Diagnostic Test C-Tb, When Given Intradermally by the Mantoux Technique to Adult Patients Recently Diagnosed With Active TB
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL) when administered intradermally by the Mantoux technique to patients in the acute phase of treatment against active TB. The secondary objectives are to assess the immune response of two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).
Detailed Description
This clinical trial is a single centre phase Ib open dose adjustment study with respect to the dose of C-Tb combined with a double blind randomised, split-body comparison of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (each patient receives the unpreserved version in one arm and the preserved version in the other arm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, ESAT-6, CFP-10, skin test, diagnostic test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.01µg C-Tb
Arm Type
Experimental
Arm Description
12-24 patients depending on a safety evaluation will receive a low dose of 0.01 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.
Arm Title
0.1µg C.Tb
Arm Type
Experimental
Arm Description
12-24 patients depending on a safety evaluation will receive a high dose of 0.1 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.
Intervention Type
Biological
Intervention Name(s)
rdESAT-6 + rCFP-10 (C-Tb)
Other Intervention Name(s)
rdESAT-6 + rCFP-10, C-Tb
Intervention Description
rdESAT-6 + rCFP-10 (C-Tb) skin test +/- phenol administered intradermally by the mantoux injection technique. Each patient receives the unpreserved version in one arm and the preserved version in the other arm in double blind manner.
Primary Outcome Measure Information:
Title
Local and systemic adverse reactions at the injection sites within 28 days after application of the tests (0.01/0.1 µg C-Tb).
Time Frame
Within 28 days after the injections
Secondary Outcome Measure Information:
Title
Immune response of 2 doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration; the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol and the pain associated with the injection of unpreserved C-Tb and preserved C-Tb
Time Frame
Within 28 days after the injections

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient: Has signed an informed consent Is willing and likely to comply with the trial procedures Has been diagnosed with active TB and has been in treatment ≤ 60 days at the time of inclusion has 1 documented positive sputum smear microscopy result has positive culture has a positive PCR result for tuberculosis has a compatible clinical picture of TB with the intention to treat Has a positive T-spot assay or a QuantiFERON®-TB Gold In Tube test Is prepared to grant authorized persons access to their medical records Exclusion Criteria: The patient: Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products) Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. BCG, MMR, yellow fever, oral typhoid vaccines) Has a known congenital or acquired immune deficiency Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) Is infected with HIV Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites Has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access Is actively participating in another clinical trial Is pregnant according to urine pregnancy test at inclusion Has a condition which in the opinion of the investigator is not suitable for participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille N Tingskov
Organizational Affiliation
Statens Serum Institut
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David JM Lewis, Professor
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George's University of London
City
London
State/Province
London SW17 0RE
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23691171
Citation
Aggerbeck H, Giemza R, Joshi P, Tingskov PN, Hoff ST, Boyle J, Andersen P, Lewis DJ. Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection. PLoS One. 2013 May 14;8(5):e64215. doi: 10.1371/journal.pone.0064215. Print 2013.
Results Reference
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A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis

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