Free Content Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial

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Abstract:

SETTING: A high tuberculosis (TB) burden rural area in South Africa.

OBJECTIVE: To compare TB case yield and disease profile among bacille Calmette-Guérin (BCG) vaccinated children using two case-finding strategies from birth until 2 years of age.

DESIGN: BCG-vaccinated infants were enrolled within 2 weeks of birth and randomised to 3-monthly home visits for questionnaire-based TB screening plus record surveillance of TB registers, hospital admission and X-ray lists at health facilities for TB suspects and cases (Group 1), or record surveillance (as above) only (Group 2). Both groups received a close-out visit after 2 years. Participants were evaluated for suspected TB disease using standardised investigations.

RESULTS: A total of 4786 infants were enrolled: 2392 were randomised to Group 1 and 2394 to Group 2. The case-finding rate was significantly greater in Group 1 (2.2/100 py) than in Group 2 (0.8/100 py), with a case-finding rate ratio of 2.6 (95%CI 1.8–4.0, P < 0.001). Although the proportion of cases with bacteriological confirmation was lower in Group 1, this difference did not reach statistical significance. There was also no significant difference in the proportions with TB symptoms and signs.

CONCLUSION: Home visits combined with record surveillance detected significantly more cases than record surveillance with a single study-end visit. The TB case profile did not differ significantly between the two groups.

Keywords: case profile; home visits; record surveillance

Document Type: Research Article

DOI: http://dx.doi.org/10.5588/ijtld.11.0348

Affiliations: 1: South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine & School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa 2: KNCV Tuberculosis Foundation, The Hague, The Netherlands; CINIMA, Academic Medical Centre, Amsterdam, The Netherlands 3: Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa 4: Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, USA; Aeras Global Tuberculosis Vaccine Foundation, Rockville, Maryland, USA 5: Pharmacology Department, University of Cape Town, Cape Town, South Africa 6: Aeras Global Tuberculosis Vaccine Foundation, Rockville, Maryland, USA

Publication date: February 1, 2012

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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