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

Synne Jenum; Sumithra Selvam; Nelson Jesuraj; Christian Ritz; Anneke C Hesseling; Vicky Cardenas; Esther Lau; Mark T Doherty; Harleen M S Grewal; Mario Vaz; TB Trials Study Group

doi:10.1136/bmjresp-2018-000304

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

Synne Jenum, Sumithra Selvam, Nelson Jesuraj, Christian Ritz, Anneke C Hesseling, Vicky Cardenas, Esther Lau, Mark T Doherty, Harleen M S Grewal, Mario Vaz, TB Trials Study Group

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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.

Originalsprog	Engelsk
Artikelnummer	e000304
Tidsskrift	B M J Open Respiratory Research
Vol/bind	5
Udgave nummer	1
Antal sider	9
ISSN	2052-4439
DOI	https://doi.org/10.1136/bmjresp-2018-000304
Status	Udgivet - 2018

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10.1136/bmjresp-2018-000304Licens: CC BY-NC

Jenum et al_B M J Open Respiratory Research_2018_Vol 5_e000304Forlagets udgivne version, 810 KBLicens: CC BY-NC

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Jenum, S., Selvam, S., Jesuraj, N., Ritz, C., Hesseling, A. C., Cardenas, V., Lau, E., Doherty, M. T., Grewal, H. M. S., Vaz, M., & TB Trials Study Group (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. B M J Open Respiratory Research, 5(1), [e000304]. https://doi.org/10.1136/bmjresp-2018-000304

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. / Jenum, Synne; Selvam, Sumithra; Jesuraj, Nelson et al.

I: B M J Open Respiratory Research, Bind 5, Nr. 1, e000304, 2018.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Jenum, S, Selvam, S, Jesuraj, N, Ritz, C, Hesseling, AC, Cardenas, V, Lau, E, Doherty, MT, Grewal, HMS, Vaz, M & TB Trials Study Group 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', B M J Open Respiratory Research, bind 5, nr. 1, e000304. https://doi.org/10.1136/bmjresp-2018-000304

@article{a26a09e26f454a04bafb820c2031122f,

title = "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",

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.",

keywords = "Clinical epidemiology, Paediatric lung disease, Respiratory infection, Tuberculosis (TB), Infants, India",

author = "Synne Jenum and Sumithra Selvam and Nelson Jesuraj and Christian Ritz and Hesseling, {Anneke C} and Vicky Cardenas and Esther Lau and Doherty, {Mark T} and Grewal, {Harleen M S} and Mario Vaz and {TB Trials Study Group}",

note = "CURIS 2018 NEXS 366",

year = "2018",

doi = "10.1136/bmjresp-2018-000304",

language = "English",

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journal = "B M J Open Respiratory Research",

issn = "2052-4439",

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TY - JOUR

T1 - Incidence of tuberculosis and the influence of surveillance strategy on tuberculosis case-finding and all-cause mortality

T2 - A cluster randomised trial in Indian neonates vaccinated with BCG

AU - Jenum, Synne

AU - Selvam, Sumithra

AU - Jesuraj, Nelson

AU - Ritz, Christian

AU - Hesseling, Anneke C

AU - Cardenas, Vicky

AU - Lau, Esther

AU - Doherty, Mark T

AU - Grewal, Harleen M S

AU - Vaz, Mario

AU - TB Trials Study Group

N1 - CURIS 2018 NEXS 366

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - Clinical epidemiology

KW - Paediatric lung disease

KW - Respiratory infection

KW - Tuberculosis (TB)

KW - Infants

KW - India

U2 - 10.1136/bmjresp-2018-000304

DO - 10.1136/bmjresp-2018-000304

M3 - Journal article

C2 - 30397482

AN - SCOPUS:85054709084

SN - 2052-4439

VL - 5

JO - B M J Open Respiratory Research

JF - B M J Open Respiratory Research

IS - 1

M1 - e000304

ER -

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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