Trial reportPloS one2013
Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
A Phase IIb Sensitivity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Adult Patients Recently Diagnosed With Active TB
Who cites it
24 citing papers in PubMed.
- C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.PloS one · 2018Trial
- Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial.Clinical and vaccine immunology : CVI · 2016Trial
- Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.PLoS neglected tropical diseases · 2014Trial
- Tuberculosis Skin Test for the Diagnosis of Pediatric Tuberculosis: Comparison with Tuberculin Skin Test and Interferon-Gamma Release Assays.Microorganisms · 2026Review
- Diagnostic accuracy and safety of Cy-Tb for detection of tuberculosis infection: A multicentric study from India.The Indian journal of medical research · 2026Observational
- Combination interventions to control the tuberculosis epidemic in the Karamoja subregion of Uganda: A modelling analysis.PLOS global public health · 2026Article
- Advances in the Diagnosis of Latent Tuberculosis Infection.Infection and drug resistance · 2025Review
- Diagnostic Accuracy ofPathogens (Basel, Switzerland) · 2024Article
- Global health 2050: the path to halving premature death by mid-century.Lancet (London, England) · 2024Review
- Overlooked, dismissed, and downplayed: reversion ofEuropean respiratory review : an official journal of the European Respiratory Society · 2024Review
- A Systematic Review on the Safety ofOpen forum infectious diseases · 2023Article
- Advances in TB testing.Advances in clinical chemistry · 2023Article
- Insights into the molecular determinants involved inVirulence · 2021Review
- Safety Evaluation of Recombinant Fusion Protein RP22 as a Skin Test Reagent for Tuberculosis Diagnosis: A Phase I Clinical Trial.Infectious diseases and therapy · 2021Article
- Differential Diagnosis of Latent Tuberculosis Infection and Active Tuberculosis: A Key to a Successful Tuberculosis Control Strategy.Frontiers in microbiology · 2021Review
- Novel Strategies for Efficient Production and Delivery of Live Biotherapeutics and Biotechnological Uses ofFrontiers in bioengineering and biotechnology · 2020Review
- Diagnosis for Latent Tuberculosis Infection: New Alternatives.Frontiers in immunology · 2020Review
- Neutrophil CD64 expression levels in IGRA-positive individuals distinguish latent tuberculosis from active disease.Memorias do Instituto Oswaldo Cruz · 2019Article
- Article
- Role of bacille Calmette-Guérin in preventing tuberculous infection.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTuberculin skin testing is simple and relatively inexpensive, but the specificity of PPD is affected by BCG vaccination.
objectiveDetermine optimal dose and specificity of recombinant ESAT-6 and CFP-10 (C-Tb) produced in Lactococcus lactis for diagnosis of M. tuberculosis infection.
methodsIn a dose finding phase I trial 0.01 or 0.1 µg preserved and unpreserved C-Tb was injected by Mantoux technique in 38 patients with active tuberculosis and induration responses measured. In a phase II specificity trial in 151 uninfected, BCG vaccinated participants 0.1 µg C-Tb was compared to 2 TU PPD.
results0.1 µg C-Tb gave a median induration of 15 mm after 2 days. Phenol preservation did not affect the response. The specificity of C-Tb was 99.3% (95% CI 96-100%) regarding indurations ≥5 mm as a positive outcome. This was higher than the specificity of PPD (63% using a cut-off of 5 mm or 92% using a cut-off of 15 mm to adjust for non-specific BCG responses). Local adverse reactions following C-Tb injection included transient itching and discomfort as expected components of the immune response.
conclusionC-Tb offers a simple and convenient skin test to diagnose M. tuberculosis infection using a single, universal cut-off unaffected by BCG vaccination.
trial registrationClinicalTrials.gov NCT01033929 and NCT01241188.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.