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BMJ Open Respir Res. 2018 Oct 9;5(1):e000304. doi: 10.1136/bmjresp-2018-000304. eCollection 2018.

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.

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Department of Clinical Science, University of Bergen, Bergen N-5021, Norway.
Department of Infectious Diseases, Oslo University Hospital, Oslo, Norway.
Division of Epidemiology, Biostatistics and Population Health, St. John's Research Institute, Bangalore, Koramangala, India.
St. John's Research Institute, Bangalore, Koramangala, India.
Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.
Desmond Tutu TB Center, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
Aeras, Rockville, Maryland, USA (Present affiliation: Aurum Institute, Rockville, Maryland, USA).
Aeras, Rockville, Maryland, USA.
Vaccines, GlaxSmitKline Vaccines, Wavre, Belgium.
Department of Microbiology, Haukeland University Hospital, Bergen, Norway.
Division of Health and Humanities, St. John's Research Institute, Bangalore, Koramangala, India.



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.


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.


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).


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.


clinical epidemiology; paediatric lung disease; respiratory infection; tuberculosis

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