By Dr. Sanchari Sinha Dutta, Ph.D.Dec 4 2022Reviewed by Benedette Cuffari, M.Sc. A multi-center, open-level, phase II/III clinical trial has recently been conducted to evaluate the efficacy and safety of the oral antimicrobial drug acoziborole in patients with human African trypanosomiasis . The findings of the trial have been published in The Lancet Infectious Diseases.
Treatment approaches with HAT depend on the disease stage. At the early-stage disease, an intramuscular injection of pentamidine is given to treat the infection. However, the late-stage disease requires more powerful treatment because of the presence of the parasite in the brain. In the current multi-center, open-level, prospective phase II/III clinical study, scientists determine the therapeutic efficacy and safety of acoziborole in patients with laboratory-confirmed HAT.
Therapeutic efficacy of acoziborole In 159 out of 167 patients with late-stage HAT, the treatment success rate at 18 months was estimated to be 95%. Treatment success was defined as a cure or probable cure, which reflected an absence of trypanosomes and less than 20 white blood cell counts per μL of cerebrospinal fluid.
Safety profile of acoziborole treatment A gradual reduction in symptom frequency was observed from day 15 post-treatment. However, about 75% of treated patients experienced 600 treatment-emergent adversities. Of these side effects, 93% were mild or moderate, and 7% were severe in intensity. The most frequently reported adversities were procedural pain and headache, headache, fever, and malaria.
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