A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects

الملخص EN

Background.

Considering the promising results of Phase I clinical trials with herbal medicine CoBaT-Y017, a Phase II study was conducted with Plasmodium falciparum malaria-infected patients, for efficacy and safety evaluation of CoBaT-Y017 compared with Artemether-Lumefantrine used as a positive control.

Methods.

A single-blind randomized trial was conducted on 25 eligible males aged 18–40 years randomly assigned to two treatment groups: CoBaT-Y017 or Artemether-Lumefantrine.

The first group received 35 ml of CoBaT-Y017 in 1.5 L mineral water administered daily for four consecutive days; the second group received oral Artemether-Lumefantrine, using WHO-recommended therapeutic dose regimens.

For both drugs, efficacy for parasite clearance and safety were evaluated clinically, haematologically, and biochemically on days 1–4, 7, 14, 21, and 28.

Clinical- and laboratory-adverse events (AEs) were recorded until day 28.

Results.

13 and 12 patients were randomized into CoBaT-Y017 arm and Artemether-Lumefantrine arm, respectively.

In all patients, parasitaemia was adequately neutralized with CoBaT-Y017 group patients’ parasite clearance lagging slightly behind that of Artemether-Lumefantrine’s group, but without a statistically significant difference (HR = 1.08, 95% CI 0.47–2.51, P=0.85).

Physical and laboratory examinations did not show any significant changes in vital signs, biochemical, and haematological parameters.

In the Artemether-Lumefantrine arm, 100% (12/12) of patients experienced, at least, one adverse event versus 61.5% (8/13) in the CoBaT-Y017 arm.

Conclusion.

CoBaT-Y017 exhibited similar antimalarial efficacy against P.

falciparum to that of Artemether-Lumefantrine, with good tolerability and safety.