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Blood tests could replace painful spleen sampling for deadly parasite

NCT ID NCT05426577

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Visceral leishmaniasis is a fatal parasitic disease if left untreated, and current methods to check whether treatment worked require invasive sampling of the spleen or bone marrow. Researchers at Gondar University Hospital in Ethiopia are evaluating blood-based immune and molecular tests to predict cure, treatment failure, and relapse. The study enrolls 60 patients with confirmed visceral leishmaniasis, and the test results do not change how patients are treated. The goal is to see whether these less invasive tests can accurately replace the current invasive methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood tests for immune and molecular markers of Leishmania infection
What this could lead to
If the blood tests prove accurate, doctors could check whether visceral leishmaniasis treatment worked without painful spleen or bone marrow sampling.
What could go wrong
The study is small and observational, so the tests may not predict cure or relapse reliably in all patients. Results from Ethiopia may not apply to other regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Primary VL patients, admitted for treatment at the Leishmaniasis Research and Treatment Centre, Gondar University Hospital, with current standard combination therapy in eastern Africa (SSG+PM). A total of 60 VL patients is the target.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis. * Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age (in the case of minors, assent from the children also needs to be obtained as per country regulatory requirements). Exclusion Criteria: VL cases will not be enrolled in the study if any of the following exclusion criteria apply: * Patients who are cases of VL relapse, post- or para-kala-azar dermal leishmaniasis or who have received any anti-leishmanial drugs within the last six months. * Patients not eligible for treatment with SSG+PM: * Patients with severe malnutrition. * Patients with positive HIV diagnosis. * Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments (SSG or PM). * Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG. * Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic), or chronic condition which would preclude evaluation of the patient's response to study medication. * Patients who cannot comply with the planned procedures and scheduled visits of the study protocol.

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Conditions

The condition(s) this trial relates to.

leishmaniasis visceral leishmaniasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Visceral leishmaniasis

Contacts and locations

Locations

  • Leishmaniasis Research and Treatment Centre, Gondar University Hospital

    Gonder, Gondar, PO BOX 196, Ethiopia

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