Table 2.
Inclusion and exclusion criteria at the enrolment sites
Study site | Rio de Janeiro (Brazil) | Lambaréné (Gabon) | Karonga (Malawi) | |||
Criteria | Inclusion | Exclusion | Inclusion | Exclusion | Inclusion | Exclusion |
Acute fever | History of fever, last 7 days | History of fever, more than 7 days previously* | History of fever, last 7 days | History of fever, more than 7 days previously* | On presentation† | More than 7 days* |
Age (years) | 2–65 | 2–17‡ | 2–65 | |||
Patient condition | Outpatient only | Critical condition | Outpatient only | Critical condition | Outpatient only | Critical condition |
Informed consent/assent | Yes | Yes | Yes | |||
Prepared to have follow-up at 2 weeks | Yes | Yes | Yes | |||
Pregnant | No exclusion | No exclusion | Yes § |
*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.