Brief Summary

Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. However, no study has documented infectious sites other than the blood compartment, considered viruses and parasites as possible causes of infection in addition to bacteria, and used molecular diagnostic methods based on PCRs, which are more sensitive. Thus, the prevalence of these co-infections and the spectrum of pathogens involved are probably underestimated, as is the impact of these co-infections on mortality. Furthermore, it has been shown that malaria infections can condition the immune cells of naturally exposed individuals, potentially leading to greater susceptibility to all types of infection. But these mechanisms have never been documented in the context of co-infections. The WHO recommends the use of broad-spectrum antibiotics in cases of severe malaria, in addition to antimalarial drugs, as it can be difficult to differentiate clinically between severe malaria and severe bacterial infection (bacteremia, pneumonia and meningitis). Yet this empirical use of antibiotics could be contributing to an increase in antibiotic resistance. Identifying the determinants of co-infection with malaria and severe bacterial infection would enable this treatment to be better targeted. These determinants remain undetermined as no study has considered other causes of severe bacterial infection other than bacteremia, used appropriate statistical methodology (univariate analysis only) and explored important determinants, notably the capacity of children's innate immunity to respond to severe bacterial infection.

Trial Health

Monitor

Trial Health Score

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

Enrollment

2,000

participants targeted

Target at P75+ for not_applicable

Timeline

15mo left

Started Feb 2025

Typical duration for not_applicable

Status

not yet recruiting

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

2.5 years study duration

Study Progress49%

Feb 2025Aug 2027

First Submitted

Initial submission to the registry

January 6, 2025

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 6, 2025

Last Update Submit

January 21, 2025

Conditions

Malaria Bacterial Co-infection

Keywords

malariaco-infectionimmune responseepigenetic mechanismschildrenTogo

Outcome Measures

Primary Outcomes (1)

Determine the extent and microbiological spectrum of malaria co-infections in children under 5.
the number of malaria co-infection events in febrile children.
3 years

Secondary Outcomes (5)

Assess the impact of malaria co-infections on mortality
2 years
Identify the underlying immunological mechanisms mediating malaria co-infections
2 years
Identify epigenetic and transcriptomic modifications in infant, maternal and placental blood cells mediating malaria co-infections
2 years
Identify molecules associated with epigenetic modifications (metabolome, proteome).
2 years
Identify determinants of malaria co-infections and severe bacterial infections.
2 years

Study Arms (1)

Febrile and non febrile children, pregnant women and new borns

OTHER

The study population is composed of children under the age of 5, which is also the population most at risk of malaria, living in the endemic areas of Lomé and Tsévié in Togo.

Other: Blood sampleOther: Urine sampleOther: oropharyngeal sampleOther: Optionnal : stool sampleOther: Optionnal : cerebrospinal fluidOther: placental biopsy

Interventions

Blood sampleOTHER

For febrile children at the time of inclusion : 6.25 ml to 8.25 ml of blood ; For non febrile children at the time of inclusion : 4 ml of blood ; For pregnant women at the time of inclusion : 5 ml of peripheral blood, 5 ml of placental blood, 20 to 40 ml of umbilical cord blood ; For new borns : drop of blood on child's heel each month and 5 ml of blood the 12th and last month.