Trial reportPloS one2018
C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642888 (A Phase III Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Phase III Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI (PPD)
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Screening tests for active pulmonary tuberculosis in children.The Cochrane database of systematic reviews · 2021Pooled it
- Accuracy of ESAT6-CFP10 skin test compared with tuberculin skin test in a healthy population: a randomized, blind, parallel controlled phase III clinical study.BMC infectious diseases · 2024Trial
- Performance of TB Antigen-Based Skin Tests Amongst Healthcare Workers-Sevagram, India, 2023-2024.Open forum infectious diseases · 2026Article
- 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
- miRNA in Diagnosis and Therapeutics of Tuberculosis: Importance in Latent and Brain Associated Pathologies.Current pharmaceutical design · 2026Review
- Reliable, accessible, cost-effective, & easy (RACE) diagnostic modality: A key for elimination of tuberculosis.The Indian journal of medical research · 2025Review
- Prevalence, Conversion and Reversion of Tuberculosis Infection Among Healthcare Workers of Tertiary Care Centres in Puducherry, India: A Prospective Cohort Study.Tropical medicine and infectious disease · 2025Article
- Evaluating the cost-effectiveness of Cy-Tb for LTBI in India: a comprehensive economic modelling analysis.International health · 2025Article
- Advancing tuberculosis elimination in India: A qualitative review of current strategies and areas for improvement in tuberculosis preventive treatment.IJID regions · 2025Review
- Diagnostic Accuracy ofPathogens (Basel, Switzerland) · 2024Article
- Effect of CD4 count on Mycobacterium tuberculosis infection rates in people living with HIV: a comparative study in prison and community.Scientific reports · 2024Article
- Article
- An Effective Health System Approach to End TB: Implementing the Double X Strategy in Vietnam.Global health, science and practice · 2024Article
- Capturing RecentTropical medicine and infectious disease · 2024Article
- Diagnosis and Management of Latent Tuberculosis Infection: Updates.Infectious disorders drug targets · 2024Review
- Observational
- Tuberculin skin testing and QuantiFERON™-TB Gold Plus positivity among household contacts in Vietnam.Public health action · 2023Article
- Pulmonary Tuberculosis in Children: A Forgotten Disease?Microorganisms · 2023Review
- ESAT-6 a Major Virulence Factor ofBiomolecules · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundC-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons.
methodsAsymptomatic South African contacts <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres. C-Tb and TST were allocated to either forearm double blinded. Samples for QFT were collected in parallel, and test-positivity rates were compared.
resultsIn participants with microbiologically confirmed TB (n = 75; 45% HIV-infected) sensitivity of C-Tb, TST and QFT were similar (72% versus 75% versus 73%; p>0.5). All 3 tests had similar positivity rates in HIV-infected participants with active TB, however, positivity rates were reduced when CD4 counts were <100 cells/μL. In participants where active TB was excluded (n = 920), C-Tb (41%), TST (43%), and QFT (44%) also had similar test-positivity rates. Among asymptomatic contacts aged below five, 32% (28/87) tested positive with C-Tb and 32% (28/87) with TST (concordance 89%). Overall, C-Tb and TST showed a similar safety profile.
conclusionC-Tb was safe and showed similar test-positivity rates, compared to TST and QFT, in children and HIV-infected persons with active or latent M. tuberculosis infection. These data inform the utility of C-Tb in clinical practice.
trial registrationClinicalTrials.gov NCT01642888. EudraCT 2011-005078-40.
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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.