THE TREATMENT OF KALA-AZAR IN THE SUDAN WITH SODIUM STIBOGLUCONATE - A RANDOMIZED TRIAL OF 3 DOSAGE REGIMENS

In a randomized study in the Sudan, 3 different regimens of sodium sti bogluconate were compared in patients with parasitologically confirmed kala-azar (visceral leishmaniasis): 10 mg/kg for 30 d (38 patients), 20 mg/kg for 30 d (29 patients), and 20 mg/kg for 15 d (37 patients). Treatment failures were defined as death, partial response, relapse, o r the development of post-kala-azar dermal leishmaniasis. The hazard r atio for failure of 20 mg/kg for 30 d vs. 10 mg/kg for 30 d was 2.1 (9 5% confidence interval [CI]=0.6, 7.6) and for 20 mg/kg for 15 d vs. 10 mg/kg for 30 d it was 1.7 (95% CI=0.5, 6.1). No significant differenc e was detected between the 3 regimens in the rate of return to normal of haematological criteria, regression of spleen size, or weight gain. After 15 d treatment parasite clearance with 20 mg/kg for 30 d and 20 mg/kg for 15 d was more profound than with 10 mg/kg for 30 d (P<0.05) , but the difference was no longer present at the end of treatment. Fu rther investigation of the effectiveness of short, intensive treatment regimens in the treatment of kala-azar is warranted.