A safety and dose finding trial of the diagnostic test C-Tb

• Research type

  Research Study

• Full 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.

• IRAS ID

  25542

• Contact name

  David JM Lewis

• Sponsor organisation

  Statens Serum Institut

• Eudract number

  2009-012984-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a safety and dose finding trial of the diagnostic test "C-Tb", given as an injection just under the skin to adult patients recently diagnosed with active Tuberculosis (TB).Tuberculosis continues to be a major cause of illness and death throughout the World. The majority of TB patients are still diagnosed with tools developed over half a centuary ago such as the injected Tuberculin Skin Test (TST) using Purified Protein Derivative (PPD), and sputum microscopy. To control the disease, fast and accurate diagnosis is very important. The new diagnostic tool to be investigated in this phase I clinical trial is a traditional skin test but with two new components: rdESAT-6 and rCFP-10, as the active ingredients. C-Tb was tested in 2008/2009 in healthy adult volunteers and found to be safe. This clinical trial is the first trial with C-Tb in patients diagnosed with tuberculosis. In this study, each patient will receive a single injection containing the same dose of C-Tb (0.01 æg/0.1 mL or 0.1 æg/0.1 mL) into each arm, but one arm will receive C-Tb in 0.5 % phenol preservative, and the other C-Tb without preservative. The purpose of skin tests is to raise a small area of inflammation which represents TB immunity. We will record the inflammation raised by C-Tb with and without phenol.The trial will be conducted at St George??s University of London, Cranmer Terrace, London, under the responsibility of principal investigator David JM Lewis. 12-36 patients will be recruited from TB clinics in South West London. The study is a single centre trial at St George??s University of London, and will continue for approximately one year. Each patient in the study will be participating for approximately 1 month in total.The trial is funded by Statens Serum Institut (SSI), Denmark.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/90

• Date of REC Opinion

  1 Dec 2009

• REC opinion

  Favourable Opinion