Clinical trial with ivermectin to treat strongyloidiasis with the aim of demonstrating that both the independent and weight-dependent dose of the patient have the same response.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Parasitic Diseases [C03]

Trial duration

8 Apr 2025 → ongoing

Decision date (initial)

2024-07-22

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III

External identifiers

EU CT number

2024-515968-32-00

EudraCT number

2022-004143-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Efficacy, Therapy, Safety, Pharmacokinetic

To assess the efficacy in terms of microbiological cure and safety of 18 mg single fixed dose ivermectin for the treatment of uncomplicated strongyloidiasis in immunocompetent adults compared to weight-adjusted single dose ivermectin.

Secondary objectives 3

1. To assess the safety, tolerability and acceptability of the two dosages of ivermectin in adult patients with uncomplicated strongyloidiasis.
2. To evaluate the usefulness of the LAMP of S. stercoralis in stool and urine samples as a tool in the diagnosis and follow-up after treatment of uncomplicated strongyloidiasis.
3. To know the population pharmacokinetics of ivermectin in a single and fixed dose of 18 mg for the treatment of uncomplicated strongyloidiasis in adult patients.

Conditions and MedDRA coding

Strongyloidiasis is caused by a parasite that is globally distributed in tropical and sub-tropical areas. Most patients with strongyloidiasis are asymptomatic or have mild symptoms with gastrointestinal disturbances, respiratory symptoms, and skin lesions. In situations of low defenses (patients under treatment with corticosteroids, organ transplant recipients or other situations) they can present serious complications with high mortality.

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age equal to or greater than 18 years.
2. Signature of the informed consent.
3. Diagnosis of strongyloidiasis either by direct parasitological methods (detection of larvae in coproparasitology or in the specific Strongyloides culture) or by positivity of a serological technique (ELISA) with an optical density index (OD) greater than or equal to 2.
4. Current residence in an area with no evidence of active transmission of strongyloidiasis.

Exclusion criteria 8

1. Pregnancy or lactation
2. Intolerance or allergy to ivermectin.
3. Presence of any condition that implies immunosuppression (both due to drugs and underlying disease): treatment with corticosteroids at a dose greater than or equal to 20 mg/day for more than 14 days, treatment with cytotoxic or antimetabolites, bone marrow transplantation or Solid organ failure, biologic drugs, active solid or hematologic neoplasm, hypogammaglobulinemia, HIV infection with a CD4 count less than 200 cells/mm3.
4. Kidney failure (glomerular filtration rate equal to or less than 30 ml/min) or advanced liver disease (Medical history and liver function profile).
5. Loa loa co-infection (due to risk of encephalopathy when administering ivermectin).
6. Complicated strongyloidiasis: Hyperinfestation syndrome due to Strongyloides (disease limited to the lungs and intestinal tract, but with severe symptoms due to the high number of larvae) or disseminated strongyloidiasis (larvae found in organs outside the lungs and intestinal tract).
7. Planned travel to an area with evidence of active strongyloidiasis transmission in the next 6 months (to prevent possible reinfections).
8. Previous treatment with ivermectin (in the last year from the inclusion date).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with microbiological cure at 6 months of treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Sponsor organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Address

Passeig De La Vall D'Hebron 119-129

City

Barcelona

Postcode

08035

Country

Spain

Scientific contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Fernando Salvador

Public contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Fernando Salvador

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications