Nifurtimox-Eflornithine Combination Therapy for Second-Stage <i>Trypanosoma brucei gambiense</i> Sleeping Sickness: A Randomized Clinical Trial in Congo.
Abstract
Background: Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second바카라 사이트恠tage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox바카라 사이트恊flornithine drug combination with the standard eflornithine regimen for the treatment of second바카라 사이트恠tage disease. Methods: A randomized, open바카라 사이트恖abel, active바카라 사이트恈ontrol, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by M茅decins Sans Fronti猫res, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. Results: A total of 103 patients with second바카라 사이트恠tage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox바카라 사이트恊flornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox바카라 사이트恊flornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox바카라 사이트恊flornithine arm. Conclusions: The nifurtimox바카라 사이트恊flornithine combination appears to be a promising first바카라 사이트恖ine therapy for second바카라 사이트恠tage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox바카라 사이트恊flornithine combination therapy will mark a major and multifaceted advance over current therapies.
Citation
Clinical Infectious Diseases (2007) 45 (11) 1435바카라 사이트�1442 [DOI: 10.1086/522982]