Table 2

Inclusion and exclusion criteria at the enrolment sites

Study siteRio de Janeiro (Brazil)Lambaréné (Gabon)Karonga (Malawi)
CriteriaInclusionExclusionInclusionExclusionInclusionExclusion
Acute feverHistory of fever, last 7 daysHistory of fever, more than 7 days previously*History of fever, last 7 daysHistory of fever, more than 7 days previously*On presentation†More than 7 days*
Age (years)2–652–17‡2–65
Patient conditionOutpatient onlyCritical conditionOutpatient onlyCritical conditionOutpatient onlyCritical condition
Informed consent/assentYesYesYes
Prepared to have follow-up at 2 weeksYesYesYes
PregnantNo exclusionNo exclusionYes §
  • *Exclusion of patients with a history of fever of more than 7 days excludes the majority of presumptive tuberculosis cases, who usually present with a fever that has lasted for over 2 weeks.

  • †In Malawi, patients were unlikely to self-medicate with antipyretics prior to their clinic visit, as was the case in Brazil and Gabon, and therefore history of fever was not added to the inclusion criteria.

  • ‡Children only, due to the setting and to counter the lower rates of child enrolment experienced in Brazil.

  • §National Health Science Research Committee (NHSRC) requirement. Women of childbearing age were asked about the possibility of pregnancy and offered a urine-based pregnancy test for confirmation.