Incidence of tuberculosis and the influence of surveillance strategy on tuberculosis case-finding and all-cause mortality: a cluster randomised trial in Indian neonates vaccinated with BCG. Issue 1 (9th October 2018)

• Record Type: Journal Article
• Authors: Jenum, Synne; Selvam, Sumithra; Jesuraj, Nelson; Ritz, Christian; Hesseling, Anneke C; Cardenas, Vicky; Lau, Esther; Doherty, T Mark; Grewal, Harleen M S; Vaz, Mario
• Other Names: author non-byline.; Jacob A author non-byline.; Jahnsen F author non-byline.; D'Souza G author non-byline.; Kurpad A V author non-byline.; Lindtjorn B author non-byline.; Macaden R author non-byline.
• Is Part Of: BMJ open respiratory research. Volume 5:Issue 1(2018)
• Publication Date: 2018-10-09
• Subjects: tuberculosis -- respiratory infection -- clinical epidemiology -- paediatric lung disease; Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Diseases -- Treatment -- Periodicals; Respiratory therapy -- Periodicals; 616.2005
• DOI: 10.1136/bmjresp-2018-000304
• Languages: English
• ISSNs: 2052-4439

Abstract

Abstract : Introduction: Accurate tuberculosis (TB) incidence and optimal surveillance strategies are pertinent to TB vaccine trial design. Infants are a targeted population for new TB vaccines, but data from India, with the highest global burden of TB cases, is limited. Methods: In a population-based prospective trial conducted between November 2006 and July 2008, BCG-vaccinated neonates in South India were enrolled and cluster-randomised to active or passive surveillance. We assessed the influence of surveillance strategy on TB incidence, case-finding rates and all-cause mortality. Predefined criteria were used to diagnose TB. All deaths were evaluated using a verbal autopsy. Results: 4382 children contributed to 8164 person-years (py) of follow-up (loss to follow-up 6.9%); 749 children were admitted for TB evaluation (active surveillance: 641; passive surveillance: 108). The TB incidence was 159.2/100 000 py and the overall case-finding rate was 3.19 per 100 py (95% CI 0.82 to 18.1). Whereas, the case-finding rate for definite TB was similar using active or passive case finding, the case-finding rate for probable TB was 1.92/100 py (95% CI 0.83 to 3.78) with active surveillance, significantly higher than 0.3/100 py (95% CI 0.01 to 1.39, p=0.02) with passive surveillance. Compared to passive surveillance, children with active surveillance had decreased risk of dying (OR 0.68, 95%CI 0.47 to 0.98) which was mostly attributable to reduction of death from pneumonia/respiratory infections (OR 0.34, 95%CI 0.14 to 0.80). Conclusion: We provide reliable estimates of TB incidence in South Indian children <2 years of age. Active surveillance increased the case-finding rates for probable TB and was associated with reduced all-cause mortality.