EXULTANT randomised 1,172 adults living with HIV admitted to hospitals in Tanzania and Mozambique. The intervention arm received sputum Xpert MTB/RIF Ultra and urine lipoarabinomannan testing irrespective of symptoms; the control arm received the same tests when symptoms or WHO criteria indicated them. Median CD4 count was 232 cells per microlitre and three-quarters were already on antiretroviral therapy.
Microbiologically confirmed tuberculosis started within 72 hours in 93 of 582 (16.0%) intervention patients and 90 of 590 (15.3%) controls — a difference of 0.7% with an interval from -3.4 to 4.8. Eight-week all-cause mortality was 25.8% against 28.8%, hazard ratio 0.86, interval 0.69 to 1.07. Median time to starting treatment was under a day in both arms.
The control-arm numbers explain the result. Of the 505 control patients eligible for sputum Xpert on symptoms, only 306 — 60.6% — actually produced a sample. Symptom-triggered testing was already reaching nearly everyone it could, and the missing 39% were missing because they could not expectorate, not because nobody asked. Expanding the eligibility criteria does not fix that. A quarter of these patients died within eight weeks either way.
- Hospitalised adults with HIV in a high-burden setting — not outpatient or low-burden screening
- The difference was 0.7%, and the interval spans a 3.4% harm to a 4.8% benefit
- Only 61% of eligible control patients produced sputum, which is the real constraint
- Mortality of about 27% at eight weeks in both arms is the number that should disturb
- A non-sputum diagnostic, not a wider testing rule, is what this points towards
The statistics, in plain English
A difference of 0.7% with an interval from -3.4 to 4.8 means the trial has excluded any large benefit and cannot rule out a small one either way. The mortality hazard ratio of 0.86 crosses 1.0, so no survival benefit was shown — but with 320 deaths this is a reasonably powered null rather than an underpowered one, which makes it more informative than most negative results.
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