Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX

Launched by INSTITUTE OF TROPICAL MEDICINE, BELGIUM · Sep 26, 2023

Keywords

ClinConnect Summary

The IMMETASEX clinical trial is investigating how malaria parasites change into their sexual forms, which is important for stopping the spread of malaria. Researchers have created a new tool that looks for specific markers in the blood to estimate how often these sexual conversions happen in people who are infected with the malaria parasite. This study is currently recruiting participants who are at least one year old, including those with severe malaria, uncomplicated malaria, or asymptomatic infections.

To participate, individuals must be willing to provide consent (or have their parents or guardians provide consent for minors) and meet certain health criteria. For example, participants with severe malaria may show symptoms like confusion, extreme weakness, or difficulty breathing, while those with uncomplicated malaria might have a fever but no severe symptoms. Participants can expect to undergo tests to determine their malaria status and will be monitored throughout the study. It's important to note that individuals with certain health issues, recent malaria treatments, or those who have recently traveled to malaria-prone areas may not be eligible.

Gender

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Eligibility 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