Clinical trial NCT01033929: A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: tuberculosis
ESAT-6
CFP-10
skin test
diagnostic test
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Local and systemic adverse reactions at the injection sites within 28 days after application of the tests (0.01/0.1 µg C-Tb).
timeFrame: Within 28 days after the injections
Secondary outcomes:
measure: 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
timeFrame: Within 28 days after the injections
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University of London
state: London SW17 0RE
Study officials:
affiliation: Statens Serum Institut
name: Pernille N Tingskov
role: STUDY_DIRECTOR
affiliation: St George's, University of London
name: David JM Lewis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.