A Trial of the C-Tb Skin Test, When Given Intradermally to Adult Patients Recently Diagnosed With Active Tuberculosis (TB)

NCT01241188 | Completed Phase 2 DMC

• 1 other identifier: TESEC-04
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test is injected just under the skin and will when positive show a redness and/or swelling at the injection site while a negative test will leave no reactions. The aim of this trial is to test the C-Tb skin test in adults diagnosed with TB to determine if a TB infected individual has a truly positive test result (this is called to find the sensitivity of the skin test).

Conditions

Tuberculosis

Keywords

tuberculosis; rdESAT-6; CFP-10; skin test; diagnostic test

Outcome Measures

Primary Outcomes (1)

• The diameter of induration at the injection sites measured transversely to the long axis of the forearm 2-3 days after application of the agents

  From injections to 2-3 days after aplication

Secondary Outcomes (4)

• Injection site adverse reactions within 28 days after application of the agents

  Onset between the injections and 28 days after the injections

• All adverse events occurring within 28 days after application of the agents

  Onset between the injections and 28 days after the injections

• Laboratory safety parameters of haematology and biochemistry

  Onset between the injections and 28 days after the injections

• In vitro IFN-γ response as measured by the QuantiFERON®-TB Gold In Tube assay

  Onset between the injections and 28 days after the injections

Study Arms (2)

0.1 µg/0.1 mL C-Tb

EXPERIMENTAL

The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme

Biological: C-Tb

2 TU Tuberculin PPD RT 23 SSI

ACTIVE COMPARATOR

The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a double blind randomisation scheme

Biological: 2 TU Tuberculin PPD RT 23 SSI

Interventions

C-Tb BIOLOGICAL

The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme

Also known as: rdESAT-6 + rCFP-10

0.1 µg/0.1 mL C-Tb

2 TU Tuberculin PPD RT 23 SSI BIOLOGICAL

The 2 TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme

Also known as: PPD, Tuberculin

2 TU Tuberculin PPD RT 23 SSI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has signed an informed consent
• Aged 18 to 65 years
• Has been diagnosed with active TB:
• has a compatible clinical picture of TB according to South African guidelines with the intention to treat and at least 1 documented positive sputum smear microscopy result or
• has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and a positive culture result
• Is HIV negative confirmed by 2 two rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA))
• Is willing and likely to comply with the trial procedures
• Is prepared to grant authorized persons access to their medical record
• Has signed an informed consent
• Aged 18 to 65 years
• Has a compatible clinical picture of TB according to South African guidelines with the intention to treat
• Is HIV positive confirmed by:
• positive rapid tests (Abbott-DetermineTM HIV-1/2 and Sensa (Seyama Solutions, SA)) or
• positive rapid tests (Abbott-DetermineTM HIV-1/2 or Sensa (Seyama Solutions, SA)) and an additional confirmatory ELISA (Enzygnost anti-HIV-1/2 Plus)
• Is willing and likely to comply with the trial procedures

You may not qualify if:

• Has been in treatment for TB for more than 2 weeks
• Has a known MDR/XDR-TB
• Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
• Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, 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
• Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
• Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
• Is pregnant, breastfeeding or intending to get pregnant
• Has a condition which in the opinion of the investigator is not suitable for participation in the study

Sponsors & Collaborators

• Statens Serum Institut: lead

Study Sites (1)

University of Cape Town Lung Institute (Pty) Ltd

Cape Town, Cape Town, 7925, South Africa

Location

Related Publications (2)

• Hoff ST, Peter JG, Theron G, Pascoe M, Tingskov PN, Aggerbeck H, Kolbus D, Ruhwald M, Andersen P, Dheda K. Sensitivity of C-Tb: a novel RD-1-specific skin test for the diagnosis of tuberculosis infection. Eur Respir J. 2016 Mar;47(3):919-28. doi: 10.1183/13993003.01464-2015. Epub 2015 Dec 17.

  PMID: 26677940 DERIVED

• 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.

  PMID: 23691171 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Birgit Thierry-Carstensen

  Statens Serum Institut Denmark

  STUDY DIRECTOR

• Keertan Dheda, MD

  University of Cape Town Lung Institute (Pty) Ltd, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

ZA (1)