Understanding how malaria parasites convert to sexual forms
Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX
This study is trying to understand what helps malaria parasites change into their sexual form so that we can find better ways to stop the spread of malaria.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 430 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 3 sites (Antwerp and 2 other locations) |
| Trial ID | NCT06064591 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the factors influencing the sexual conversion of Plasmodium parasites, which is crucial for interrupting malaria transmission. Researchers will develop a new tool to estimate sexual conversion rates based on the expression analysis of sexual stage biomarkers in natural infections. The study will explore how host immune and metabolic changes during malaria infection affect these conversion rates, utilizing single-cell RNA sequencing to uncover the underlying transcriptional mechanisms. The ultimate goal is to identify immune factors and metabolites that promote sexual conversion, potentially leading to novel strategies for malaria transmission control.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals aged 1 year and older who are symptomatic for Plasmodium falciparum or residents of malaria-endemic areas.
Not a fit: Patients who are not infected with Plasmodium falciparum or those who do not meet the age and symptomatic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new methods for interrupting malaria transmission, ultimately reducing the burden of malaria on affected populations.
How similar studies have performed: While the approach of studying sexual conversion in malaria parasites is critical, it is a novel area of investigation with limited prior studies demonstrating success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 1 year * Willing and able to provide written informed consent (or assent for minors with written informed consent by parent(s) and/or guardian(s). Pilot: -symptomatic for P. falciparum -/Travel to P. falciparum endemic area within the last month WP1: * Resident in Nanoro district * non-symptomatic individuals WP2: * Positive for P. falciparum infection via Rapid Diagnostic Tests (RDT) * Age: ≥ 1 and ≤ 12 years * Patients are included when suspected of the following conditions: I. Severe malaria by infection with P. falciparum is defined in the presence of P. falciparum asexual parasitemia, and as one or more of the following: 1. Impaired consciousness: A Blantyre coma score \< 3 (when patients are ≤ 6 years) or Glasgow coma score \< 10 (when patients are ≥ 6 years). 2. Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance. 3. Multiple convulsions: More than two episodes within 24 hours. 4. Clinical manifestation of respiratory distress (e.g., rapid, deep and labored breathing). 5. Diagnosis through exclusion: absence of an identified alternative cause. II. Uncomplicated malaria by infection with P. falciparum is defined as a patient who presents with lethargic profile (e.g. fever) and a positive parasitological test for P. falciparum, but with no features of severe malaria. Exclusion Criteria: * Delayed developmental status or history of chronic illness * Participation in another study * Previous malaria treatment or prophylaxis in the last week * Inability or unwillingness of the parents or guardians to provide informed consent WP1: * Symptoms of malaria, as defined by presence of fever (body temperature \>37.5 °C or history of fever during the past 48 hours) with a positive RDT (RDT are performed always when there is presence of fever) * Any plans to leave the study are in the coming 10 days WP2: * Severe anemia (will be determined via clinical examination), since blood samples can hardly be withdrawn, co-morbidities. * A questionnaire will be used during the clinical assessment that addresses following exclusion criteria: x Antimalarial drug treatment or other medication during the past week x If the patient had a meal within 4 hours before admission x Patients with acute meningitis (as clinically evaluated according to the local guidelines) x Patients with developmental delay or history of chronic illness x Vaccination during the past week
Where this trial is running
Antwerp and 2 other locations
- Institute of Tropical Medicine Antwerp — Antwerp, Belgium (Recruiting)
- Institut de Recherche en Sciences de la Santé - Clinical Research Unit of Nanoro — Nanoro, Burkina Faso (Not_yet_recruiting)
- Instituto Nacional de Saúde (INS) — Maputo, Mozambique (Not_yet_recruiting)
Study contacts
- Principal investigator: Anna Rosanas-Urgell, Prof — Itm
- Study coordinator: Vera EA Kühne, PhD
- Email: vkuhne@itg.be
- Phone: +32(0)33455833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.