Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX
NCT ID: NCT06064591
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
430 participants
OBSERVATIONAL
2023-12-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pilot study Belgium Patients
Patients (P. falciparum-infected)
No intervention 6 ml of venous blood sampled at one time point
No interventions assigned to this group
Pilot study Belgium Controls
Control non-infected individuals No intervention 6 ml of venous blood sampled at one time point
No interventions assigned to this group
Work package 1 Burkina Faso Asymptomatic
Asymptomatic (P. falciparum-infected) No intervention Venous blood sample (maximum of 8 ml) at 1 time point. 300µl of finger prick blood at four follow-up visits 24, and 48 and 72h and day 10 after the enrollment.
No interventions assigned to this group
Work package 1 Burkina Faso uncomplicated patients
uncomplicated patients (P. falciparum-infected) No intervention Venous blood sample (maximum of 8 ml) at 1 time point.
No interventions assigned to this group
Work package 1 Burkina Faso Controls
Control non-infected individuals No intervention Venous blood sample (maximum of 8 ml) at 1 time point.
No interventions assigned to this group
Work package 2 Mozambique Uncomplicated malaria patients
Uncomplicated malaria patients No intervention Venous blood sample (maximum of 6 ml) at 1 time point.
No interventions assigned to this group
Work package 2 Mozambique Severe malaria patients
Severe malaria patients No intervention Venous blood sample (maximum of 6 ml) at 1 time point.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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
1 Year
ALL
Yes
Sponsors
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Instituto Nacional de Saúde, Mozambique
OTHER_GOV
Clinical Research Unit of Nanoro (CRUN), Burkina Faso
UNKNOWN
Barcelona Institute for Global Health
OTHER
Leiden University Medical Center
OTHER
KU Leuven
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Anna Rosanas-Urgell, Prof
Role: PRINCIPAL_INVESTIGATOR
ITM
Locations
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Institute of Tropical Medicine Antwerp
Antwerp, , Belgium
Institut de Recherche en Sciences de la Santé - Clinical Research Unit of Nanoro
Nanoro, , Burkina Faso
Instituto Nacional de Saúde (INS)
Maputo, , Mozambique
Countries
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Central Contacts
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Facility Contacts
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Vera Kühne, PhD
Role: primary
Hamtandi M NATAMA, Prof
Role: primary
Paulo Arnaldo, PhD
Role: primary
Other Identifiers
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G067823N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IMMETASEX 1704/23
Identifier Type: -
Identifier Source: org_study_id
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