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

NCT01033929 | Completed Phase 1 DMC

• 2 other identifiers: TESEC-022009-012984-33
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Within 28 days after the injections

Secondary Outcomes (1)

• 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

  Within 28 days after the injections

Study Arms (2)

0.01µg C-Tb

EXPERIMENTAL

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.

Biological: rdESAT-6 + rCFP-10 (C-Tb)

0.1µg C.Tb

EXPERIMENTAL

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.

Biological: rdESAT-6 + rCFP-10 (C-Tb)

Interventions

rdESAT-6 + rCFP-10 (C-Tb) BIOLOGICAL

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.

Also known as: rdESAT-6 + rCFP-10, C-Tb

0.01µg C-Tb; 0.1µg C.Tb

Eligibility Criteria

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

You may qualify if:

• The patient:
• Has signed an informed consent
• Is willing and likely to comply with the trial procedures
• 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

You may not qualify if:

• The patient:
• 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
• 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)

St George's University of London

London, London SW17 0RE, SW17 0RE, United Kingdom

Location

Related Publications (1)

• 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernille N Tingskov

  Statens Serum Institut

  STUDY DIRECTOR

• David JM Lewis, Professor

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 16, 2009
• First Posted: December 17, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

GB (1)