Delamanid is a nitro-dihydro-imidazooxazole derivative that inhibits mycolic acid synthesis and has potent in vitro and in vivo activity against drug-resistant strains of Mycobacterium tuberculosis.
A randomised, placebo-controlled trial in 481 patients with pulmonary multidrug-resistant tuberculosis showed that addition of delamanid 100mg twice daily to background therapy increased the sputum-culture conversion rate (as assessed in liquid broth medium) at 2 months to 45.4%, compared with 29.6% for addition of placebo (p=0.008).
In an observational follow-up study in 421 participants, the rate of favourable outcomes (cure or treatment completion) at 24 months was significantly higher in those who received delamanid for ≥6 months than in those who were treated for ≤2 months (74.5% vs 55%; RR 1.35 [95% CI 1.17–1.56], p<0.001). Mortality rates were also significantly reduced with extended treatment (1.0% vs 8.3%, p<0.001).
The most frequently reported adverse effects of delamanid were nausea, vomiting and dizziness. However, QT interval prolongation was the most notable safety concern.
The recommended dose for adults is 100mg twice daily for 24 weeks.
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