Clinical Trial

Host Immunity, Plasmodium and Pathogens Co-Infections

Study acronym: HIPPI
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-06.
Trial Details
NCT Number NCT06769815
Lead Sponsor Institut Pasteur
Collaborators: Institut de Recherche pour le Developpement
Conditions Malaria, Bacterial Co-infection
Enrollment 2,000 participants
Start Date 2025-02-15
Primary Completion 2027-02-15 (estimated)
Study Completion 2027-08-15 (estimated)
Updated on ClinicalTrials.gov 2025-01-24