Host Immunity, Plasmodium and Pathogens Co-Infections

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstitut Pasteur

About this trial

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.

Eligibility criteria

Qualifiers

aged between 6 and 60 months

with a febrile episode lasting less than 7 days (axillary temperature >=37.5° Celsius)

whose state of health is compatible with a minimum single blood sample volume of 6.25 ml

aged between 6 and 60 months

Disqualifiers

scheduled caesarean section for current pregnancy

Caesarean section in previous pregnancies

chronic non-infectious pathology during pregnancy (diabetes, hypertension, pre-eclampsia)

Trial design

Treatments tested in this trial

  • Blood sample
  • Urine sample
  • oropharyngeal sample
  • Optionnal : stool sample
  • Optionnal : cerebrospinal fluid
  • placental biopsy

Treatment groups

2,000 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Institut Pasteur

Lead sponsor

Institut de Recherche pour le Developpement

Collaborator