Host Immunity, Plasmodium and Pathogens Co-Infections

NCT06769815 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Blood sample

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.

OTHER

Urine sample

For febrile children : 10 ml of urine

OTHER

oropharyngeal sample

For febrile children : oropharyngeal swab sampling

OTHER

Optionnal : stool sample

For febrile children (only as part of the care of the child) : 5g stool

OTHER

Optionnal : cerebrospinal fluid

For febrile children (only as part of the care of the child in case of suspected meningitis) : 4 additional drops of cerebrospinal fluid

OTHER

placental biopsy

For pregnant women : placental biopsy the size of 2 rice grains

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement

    collaborator OTHER_GOV
  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Bich-Tram Huynh, PhD · Institut Pasteur

  • Luc Douti, MD · CHU-Campus de Lomé

  • Serge Ekoué Gbadoe, MD · Hôpital de district Polyclinique de Zio-Tsévié

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2027-02-15
Completion
2027-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769815 on ClinicalTrials.gov