Efficacy and Safety of Fixed-Dose Ivermectin Versus Weight-Adjusted Ivermectin in Treating Uncomplicated Strongyloidiasis in Immunocompetent Adults

The primary objective of this study is to assess the **efficacy** in terms of microbiological cure and safety of an 18 mg single fixed dose of **ivermectin** for the treatment of uncomplicated **strongyloidiasis** in immunocompetent adults, compared to a weight-adjusted single dose of ivermectin. This evaluation is clinically relevant as it aims to determine whether a fixed dose can provide a similar therapeutic outcome to a weight-based regimen, potentially simplifying treatment protocols and improving patient compliance.

Secondary objectives include: - Assessing the safety, tolerability, and acceptability of two dosages of ivermectin in adult patients with uncomplicated strongyloidiasis. - Evaluating the usefulness of the LAMP of **S. stercoralis** in stool and urine samples as a diagnostic and follow-up tool after treatment. - Understanding the population pharmacokinetics of ivermectin in a single and fixed dose of 18 mg for the treatment of uncomplicated strongyloidiasis in adult patients.

The clinical trial involves a study population comprising **immunocompetent adults** aged 18 years and older, including both male and female participants. The sponsor has not provided the total number of participants. The trial population was selected based on specific inclusion criteria, such as a confirmed diagnosis of **strongyloidiasis** through direct parasitological methods or serological techniques, and current residence in an area without active transmission of the disease. Participants are expected to be in general good health, without any significant vulnerabilities. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The study does not target a vulnerable population, ensuring a focus on individuals who are not at increased risk due to underlying health conditions or other factors.

The clinical trial is designed as a **randomized**, non-inferiority study to evaluate the efficacy and safety of a single fixed dose of 18 mg **ivermectin** for the treatment of uncomplicated **strongyloidiasis** in immunocompetent adults. The trial will compare this fixed dose to a weight-adjusted single dose of ivermectin. The study is categorized as a Phase 4 trial with a low level of intervention, in accordance with regulatory standards. The trial is expected to commence recruitment on October 27, 2023, and conclude by October 27, 2026.

Participants will be involved in the study for a maximum treatment period of one day, with follow-up assessments extending up to six months to evaluate the primary endpoint, which is the proportion of patients achieving microbiological cure. The trial will include several key visits: an initial **screening** visit to confirm eligibility, follow-up visits to monitor safety and efficacy, and an end-of-study visit to assess the final outcomes. Inclusion criteria require participants to be 18 years or older, provide informed consent, have a confirmed diagnosis of strongyloidiasis, and reside in an area with no active transmission of the disease.

Participants may be terminated early from the study if they withdraw consent, experience adverse events that necessitate discontinuation, or if they do not adhere to the study protocol. The trial is designed to ensure that all procedures are conducted in a **double-blind** manner, maintaining the integrity of the data collected. The study aims to provide valuable insights into the treatment of strongyloidiasis, contributing to the optimization of therapeutic strategies for this condition.

The clinical trial involves the administration of **IVERMECTIN**, an antiparasitic agent, as the experimental medication. The pharmaceutical form of ivermectin is designated as PHF00245MIG. The medication is administered orally, with a single fixed dose of 18 mg being used for the treatment of uncomplicated strongyloidiasis in immunocompetent adults. The maximum daily and total dose is 21 mg, and the treatment period is limited to one day. The active substance, ivermectin, is a mixture, and it is identified by the ATC code P02CF01. The synonyms for ivermectin include L-640471, EQU-001, CD5024, and MK-933. The trial aims to evaluate the efficacy of this fixed dose compared to a weight-adjusted single dose of ivermectin.

In addition to the experimental treatment, the study may involve the use of a comparator treatment, which is a weight-adjusted single dose of ivermectin. This comparator serves as a standard-of-care therapy to assess the non-inferiority of the fixed dose regimen. The trial does not involve the use of a placebo. Participant compliance with the dosing schedule will be monitored to ensure adherence to the treatment protocol. The trial is designed to assess both the microbiological cure and safety of the fixed dose regimen in comparison to the weight-adjusted dose.

The efficacy of the clinical trial will be assessed by evaluating the **microbiological cure** of uncomplicated strongyloidiasis in immunocompetent adults. The primary endpoint for efficacy is the proportion of patients achieving microbiological cure at six months following treatment with a single fixed dose of 18 mg ivermectin. This endpoint will be measured by direct parasitological methods, such as the detection of larvae in coproparasitology or specific Strongyloides culture, or by serological techniques like ELISA with an optical density index greater than or equal to 2. The trial is designed as a randomized non-inferiority study to compare the efficacy of the fixed dose regimen against a weight-adjusted single dose of ivermectin.