NCT06064591

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

September 26, 2023

Last Update Submit

March 9, 2026

Conditions

Uncomplicated MalariaSevere MalariaAsyptomatic Plasmodium Infection

Outcome Measures

Primary Outcomes (1)

  • To validate a Sexual Conversion Estimator tool

    To validate a Sexual Conversion Estimator tool to accurately estimate SC rates and future transmission potential in epidemiological samples. First, the investigators will measure expression levels of SRBs and directly determine SC rates in samples from malaria asymptomatic patients. Second, the investigators will use a machine learning classifier to determine the combination of SRBs that best predicts SC rates; and third, the investigators will measure the predictive value of the Estimator tool for future transmission potential

    2023-2025

Secondary Outcomes (3)

  • To investigate in malaria patients associations between host immune and metabolic factors and P. falciparum sexual conversion and infection potential

    2023-2025

  • To validate associations between sexual conversion and host immune and metabolic factors in vitro

    2024-2026

  • To explore transcriptional mechanisms driving parasite sexual conversion in the host environment during uncomplicated and severe malaria disease

    2024-2026

Study Arms (7)

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 Uncomplicated Malaria Patients

Control non-infected individuals No intervention Venous blood sample (maximum of 6 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 Burkina Faso Severe malaria patients

Severe malaria patients No intervention Venous blood sample (maximum of 6 ml) at 1 time point.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pilot: This study will be performed at the policlinic of ITM, in Antwerp, Belgium. WP1 Recruitment screenings will be organized in Nanoro village, within the catchment area of the existing health demographic surveillance system (HDSS) of Nanoro Health district (NHD), Burkina Faso. WP2 The study will include pediatric patients with uncomplicated and severe malaria (aged ≥ 1 and ≤ 12 years, male and female) visiting Chókwè Rural Hospital, Mozambique, and the peripheral health centers in Chókwè district.

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Tropical Medicine Antwerp

Antwerp, Antwerp, 2000, Belgium

Location

Institut de Recherche en Sciences de la Santé - Clinical Research Unit of Nanoro

Nanoro, Burkina Faso

Location

Instituto Nacional de Saúde (INS)

Maputo, Mozambique

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood sample

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Anna Rosanas-Urgell, Prof

    ITM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

December 13, 2023

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

BE(1)MO(1)BU(1)