Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial
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.
Document Type: Research Article
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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