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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario De Valencia Valencia Spain
Fmckvlnkf Pznk Lv Imsdgqvvewwyr Bvqcdrzvy Dhf Hiljtrrm Ufgbvulnzhozs Lk Plv Madrid Spain
Hgwmknfw Unbuqcrdtqcik Hliuuiog Ttjib y Psuegb Icbaxzei Clkfte dcczxzeykafpauwxh (zfes Badalona Spain
Hbrfvplf Vett drfovqnn Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
27.10.2023

Trial locations

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.

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 ID:
2024-515968-32-00
Protocol code:
STRONG-FIX
Trial Phase:
Therapeutic exploratory (Phase II)

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