title: Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial.
abstract: METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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. sizulu.moyo@uct.ac.za
authors.forename: S
authors.initials: S
authors.lastname: Moyo
authors.forename: S
authors.initials: S
authors.lastname: Verver
authors.forename: A
authors.initials: A
authors.lastname: Hawkridge
authors.forename: L
authors.initials: L
authors.lastname: Geiter
authors.forename: M
authors.initials: M
authors.lastname: Hatherill
authors.forename: L
authors.initials: L
authors.lastname: Workman
authors.forename: C
authors.initials: C
authors.lastname: Ontong
authors.forename: W
authors.initials: W
authors.lastname: Msemburi
authors.forename: M
authors.initials: M
authors.lastname: Tameris
authors.forename: H
authors.initials: H
authors.lastname: Geldenhuys
authors.forename: H
authors.initials: H
authors.lastname: Mulenga
authors.forename: M A
authors.initials: MA
authors.lastname: Snowden
authors.forename: W A
authors.initials: WA
authors.lastname: Hanekom
authors.forename: G
authors.initials: G
authors.lastname: Hussey
authors.forename: H
authors.initials: H
authors.lastname: Mahomed
mesh_terms: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006792:House Calls / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008403:Mass Screening / Q000379:methods*; D018579:Patient Selection; D012189:Retrospective Studies; D012424:Rural Population / Q000706:statistics & numerical data*; D013019:South Africa / Q000453:epidemiology; D011795:Surveys and Questionnaires; D014376:Tuberculosis / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine