NCT01631266

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. We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD), the C-Tb test is injected just under the skin and will, when positive, show 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 volunteers. The volunteers are divided into four groups:

  • Negative control group: Must have no history of exposure to a person with tuberculosis disease.
  • Occasional contact: Must be in contact with a person with tuberculosis disease between 6 hours/week and 6 hours/day
  • Close contact: Must be in close contact with a person with tuberculosis disease for more than 6 hours/day for at least five days
  • Positive control group: Must have a confirmed tuberculosis disease within the last 3 years. The goals of this clinical trial are:
  • To compare the C-Tb test to a blood test, the QuantiFERON test.
  • To compare the C-Tb test to the PPD test that is currently being used.
  • To assess the safety of the C-Tb test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
979

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

June 28, 2012

Last Update Submit

April 16, 2015

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm

    Onset between the injections and 28 days after the injections

Secondary Outcomes (19)

  • To demonstrate a significantly lower response rate of C-Tb as compared to that of PPD RT23 SSI in the BCG vaccinated participants in the negative control group, with response defined as any induration (> 1mm) for both agents

    Onset between the injections and 28 days after the injections

  • To evaluate a possible trend in C-Tb induration diameters across the four pre-specified MTb infection risk sub-groups

    Onset between the injections and 28 days after the injections

  • To evaluate a possible trend in PPD RT23 SSI induration diameters across the four pre-specified MTb infection risk sub-groups

    Onset between the injections and 28 days after the injections

  • To evaluate a possible trend in QuantiFERON Gold In-Tube results across four pre-specified MTb infection risk sub-groups

    On the day of the injections

  • To evaluate a possible trend in PPD RT23 SSI test positivity across four pre-specified MTb infection risk sub-groups

    Onset between the injections and 28 days after the injections

  • +14 more secondary outcomes

Study Arms (2)

0.1 µg/0.1 mL C-Tb

EXPERIMENTAL

The C-Tb and 2 T.U. 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 T.U. Tuberculin PPD RT 23 SSI

ACTIVE COMPARATOR

The C-Tb and 2 T.U. 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 T.U. Tuberculin PPD RT 23 SSI

Interventions

C-TbBIOLOGICAL

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

0.1 µg/0.1 mL C-Tb
2 T.U. Tuberculin PPD RT 23 SSIBIOLOGICAL

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

2 T.U. Tuberculin PPD RT 23 SSI

Eligibility Criteria

Age6 Weeks - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Can comply with one of the following groups:
  • Negative control group: Must have no history of exposure to a TB index case, and have no signs or symptoms of TB
  • Positive control group: Confirmed TB disease within the last 3 years by sputum smear microscopy and/or Culture, Gene Xpert or PCR
  • Close contact group: Must be in close contact with a pulmonary smear positive TB index case for more than 6 hours/day for at least five days
  • Occasional contact group: Must be in contact with a pulmonary sputum smear positive TB index case between 6 hours/week and 6 hours/day
  • Is between 6 weeks - 65 years of age
  • Participant, parent or legal guardian has provided signed informed consent
  • Is willing and likely to comply with the trial procedures
  • Is prepared to grant authorized persons access to their medical records

You may not qualify if:

  • Is pregnant, breastfeeding or intending to get pregnant within the trial period
  • Is a female of child bearing potential (12 years of age or older having had their first menstruation) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period
  • 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 C-Tb and Tuberculin PPD RT23 SSI 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 participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  • Current participation in another clinical trial with an investigational or non investigational drug or device, which in the opinion of investigator may interfere with this trial drug
  • Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens
  • Has a condition which in the opinion of the investigator is not suitable for participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital Universitario de Cruces

Barakaldo, Basque Country, 48903, Spain

Location

CAP Drassanes, Unitat de Prevenció i Control de Tuberculosi

Barcelona, Catalonia, 08001, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Public Health Agency of Barcelona

Barcelona, Catalonia, 08023, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Mutua de Terrassa

Barcelona, Catalonia, 08221, Spain

Location

Hospital San Joan De Deu

Barcelona, Catalonia, 08950, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27004, Spain

Location

Complexo Hospitalario de Pontevedra

Pontevedra, Galicia, 36071, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Complexo Hospitalario Universitario de Vigo

Vigo, Galicia, +34 981 950 036, Spain

Location

Related Publications (1)

  • Ruhwald M, Aggerbeck H, Gallardo RV, Hoff ST, Villate JI, Borregaard B, Martinez JA, Kromann I, Penas A, Anibarro LL, de Souza-Galvao ML, Sanchez F, Rodrigo-Pendas JA, Noguera-Julian A, Martinez-Lacasa X, Tunez MV, Fernandez VL, Millet JP, Moreno A, Cobos N, Miro JM, Roldan L, Orcau A, Andersen P, Cayla JA; TESEC Working Group. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon gamma release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial. Lancet Respir Med. 2017 Apr;5(4):259-268. doi: 10.1016/S2213-2600(16)30436-2. Epub 2017 Feb 1.

    PMID: 28159608DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Joan Cayla, MD

    Public Health Agency of Barcelona

    PRINCIPAL INVESTIGATOR

  • Henrik Aggerbeck, M. Sc.

    Statens Serum Institut

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
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

June 28, 2012

First Posted

June 29, 2012

Study Start

July 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

ES(13)