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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will estimate sexual conversion rates in natural infections.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: t
View:

⁃ 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:

‣ Impaired consciousness: A Blantyre coma score \< 3 (when patients are ≤ 6 years) or Glasgow coma score \< 10 (when patients are ≥ 6 years).

‣ Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.

‣ Multiple convulsions: More than two episodes within 24 hours.

‣ Clinical manifestation of respiratory distress (e.g., rapid, deep and labored breathing).

‣ 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.

Locations
Other Locations
Belgium
Institute of Tropical Medicine Antwerp
RECRUITING
Antwerp
Burkina Faso
Institut de Recherche en Sciences de la Santé - Clinical Research Unit of Nanoro
NOT_YET_RECRUITING
Nanoro
Mozambique
Instituto Nacional de Saúde (INS)
NOT_YET_RECRUITING
Maputo
Contact Information
Primary
Vera EA Kühne, PhD
vkuhne@itg.be
+32(0)33455833
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2026-12
Participants
Target number of participants: 430
Treatments
Pilot study Belgium Patients
Patients (P. falciparum-infected)~No intervention 6 ml of venous blood sampled at one time point
Pilot study Belgium Controls
Control non-infected individuals No intervention 6 ml of venous blood sampled at one time point
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.
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.
Work package 1 Burkina Faso Controls
Control non-infected individuals No intervention Venous blood sample (maximum of 8 ml) at 1 time point.
Work package 2 Mozambique Uncomplicated malaria patients
Uncomplicated malaria patients No intervention Venous blood sample (maximum of 6 ml) at 1 time point.
Work package 2 Mozambique Severe malaria patients
Severe malaria patients No intervention Venous blood sample (maximum of 6 ml) at 1 time point.
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Research Unit of Nanoro (CRUN), Burkina Faso, Barcelona Institute for Global Health, Instituto Nacional de Saúde, Mozambique, KU Leuven, Leiden University Medical Center
Leads: Institute of Tropical Medicine, Belgium

This content was sourced from clinicaltrials.gov