Randomized, Double-blind Trial Evaluating the Safety and Efficacy of a 3- or 5-Day Course of Levamisole 2.5 mg/kg in Subjects With Loa Loa Microfilaremia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of levamisole given for either 3 or 5 days to treat loiasis, a parasitic disease caused by Loa loa. This trial addresses challenges in managing loiasis microfilaremia, particularly in regions where onchocerciasis and loiasis coexist, by testing levamisole as an alternative treatment to current therapies. The study is a randomized, double-blind clinical trial designed to see if longer levamisole treatment can reduce the parasite load safely and effectively. Participants are randomly assigned to one of three groups: a 3-day treatment of levamisole followed by 2 days of placebo, a 5-day treatment of levamisole, or a 5-day placebo group. Each dose of levamisole is 2.5 mg/kg. The study monitors treatment tolerance during the 5 days of administration and for 2 weeks afterward, while also measuring the effect on Loa loa microfilaremia from day 3 through day 30 after the first dose. During the trial, participants will undergo clinical examinations and complete questionnaires to assess health and safety. Researchers will track the parasite levels and any side effects through this period. The total participation involves treatment and follow-up visits extending up to 30 days post-treatment to evaluate both safety and parasite reduction outcomes.

A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects