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Study on Ivermectin for Treating Strongyloidiasis in Adults with Normal Immune Function

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of strongyloidiasis, a disease caused by a parasite commonly found in tropical and subtropical regions. Many people with strongyloidiasis do not show symptoms or have mild issues like stomach problems, breathing difficulties, and skin rashes. However, in individuals with weakened immune systems, such as those taking certain medications or who have had organ transplants, the disease can lead to serious complications.

The trial will use a medication called ivermectin, which is an antiparasitic agent. The study aims to evaluate the effectiveness and safety of a single fixed dose of 18 mg ivermectin compared to a dose adjusted based on the patient's weight. The goal is to determine if both dosing methods provide the same response in treating uncomplicated strongyloidiasis in adults with healthy immune systems.

Participants in the study will receive either the fixed dose or the weight-adjusted dose of ivermectin. The trial will monitor the participants over a period to assess the microbiological cure, which means checking if the parasite is eliminated from the body, and to ensure the treatment is safe. The study will help understand the best way to use ivermectin for treating strongyloidiasis effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing the informed consent form, confirming understanding and agreement to participate in the study.

    Eligibility is confirmed based on age (18 years or older), diagnosis of strongyloidiasis, and current residence in an area without active transmission of the disease.

  2. Step 2

    Initial assessment

    An initial health assessment is conducted to ensure suitability for the trial. This includes confirming the diagnosis of strongyloidiasis through specific tests.

  3. Step 3

    Medication administration

    A single fixed dose of 18 mg ivermectin is administered orally. This medication is used to treat uncomplicated strongyloidiasis.

    The aim is to evaluate the effectiveness of this fixed dose compared to a weight-adjusted dose.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor health and assess the response to treatment.

    The primary goal is to determine the proportion of patients achieving a microbiological cure at 6 months after treatment.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by October 27, 2026, with final assessments conducted to evaluate the overall outcomes and safety of the treatment.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Must sign the **informed consent**, which is a document that explains the study and confirms your agreement to participate.
  • Must have a **diagnosis of strongyloidiasis**, which is an infection caused by a parasite. This can be confirmed by:
    • Finding the parasite's larvae in stool tests or specific cultures.
    • Testing positive in a **serological test** called ELISA, which checks for antibodies in your blood, with a result index of 2 or higher.
    • Must currently live in an area where there is **no active transmission** of strongyloidiasis, meaning the infection is not currently spreading in that area.

Who cannot join the trial?

6 criteria

  • Patients who have a weakened immune system, which means their body's defense system is not strong enough to fight infections.
  • Patients who are currently taking medications called corticosteroids, which are drugs that reduce inflammation in the body.
  • Patients who have had an organ transplant, which is a medical procedure where a damaged organ is replaced with a healthy one from a donor.
  • Patients who are pregnant or breastfeeding, as the safety of the treatment for these individuals is not established.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or instructions for any reason.
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Investigated drugs

Ivermectin: This medication is used in the trial to treat uncomplicated strongyloidiasis, a type of parasitic infection. The trial is comparing the effectiveness and safety of a single fixed dose of ivermectin to a weight-adjusted single dose. Ivermectin works by paralyzing and killing the parasites, helping to clear the infection from the body.

What is already known about the treatment

Ivermectin – Ivermectin is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating uncomplicated strongyloidiasis, a parasitic infection. The main therapeutic use of ivermectin is to eliminate parasitic infections, particularly those caused by roundworms. At the molecular level, ivermectin works by binding to specific channels in the nerve and muscle cells of parasites, leading to paralysis and death of the parasite. It is classified as an antiparasitic medication.

Investigated diseases

Strongyloidiasis – Strongyloidiasis is an infection caused by a parasitic worm, primarily found in tropical and subtropical regions. Many individuals with this condition do not exhibit symptoms, but some may experience mild gastrointestinal issues, respiratory symptoms, and skin rashes. The disease can become more severe in individuals with weakened immune systems, such as those undergoing corticosteroid treatment or organ transplant recipients. In such cases, the infection can lead to serious complications. The parasite can persist in the body for many years, often without causing noticeable symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515968-32-00Protocol codeSTRONG-FIXEstimated enrolment276 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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