Background: In 2007, WHO released revised recommendations and an algorithm for the diagnosis and treatment of smear-negative pulmonary tuberculosis in seriously ill people living with HIV/AIDS. We aimed to assess the effect of the recommendations on clinical outcome in patients in South Africa.
Methods: We enrolled seriously ill patients (aged ≥15 years) with HIV infection and suspected smear-negative pulmonary tuberculosis from three hospitals in KwaZulu-Natal, South Africa. Patients were consecutively enrolled into two cohorts: the first cohort was managed according to standard practice, and the second according to the WHO-recommended algorithm. The primary endpoints were rates of continued stay in hospital at 7 days after admission and survival at 8 weeks after admission.
Findings: 338 patients were enrolled in the standard practice cohort between August, 2008, and February, 2009, and 187 were enrolled in the algorithm cohort between March, 2009, and December, 2009. 7 days after hospital admission, 27% (n=50) of patients in the algorithm cohort were still in hospital, compared with 38% (n=130) in the standard practice cohort (rate ratio 0·70, 95% CI 0·53-0·91; p=0·009). 8 weeks after admission, 83% (n=156) of patients in the algorithm cohort were alive, compared with 68% (n=230) in the standard practice cohort (1·23, 1·11-1·35; p=0·0001), with effect modified by hospital location.
Interpretation: In seriously ill patients with HIV infection and suspected smear-negative pulmonary tuberculosis, early antituberculosis treatment according to the WHO algorithm could significantly reduce mortality in South Africa.
Funding: US President's Emergency Plan for AIDS Relief.
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