NCT06769815: HIPPI

Host Immunity, Plasmodium and Pathogens Co-Infections

Not yet recruiting NA Last updated 24 January 2025

What this trial tests

NA trial testing Blood sample in Malaria in 2,000 participants. Not yet recruiting.

Timeline

15 February 2025

Primary endpoint
15 February 2027

15 August 2027

Quick facts

Lead sponsor	Institut Pasteur
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	2,000
Start date	15 February 2025
Primary completion	15 February 2027
Estimated completion	15 August 2027

Drugs / interventions tested

• Blood sample — full drug profile →
• Urine sample — full drug profile →
• oropharyngeal sample
• Optionnal : stool sample
• Optionnal : cerebrospinal fluid
• placental biopsy

Conditions studied

• Malaria — all drugs for Malaria →
• Bacterial Co-infection — all drugs for Bacterial Co-infection →

Sponsor

Institut Pasteur — full company profile →

Who can join

Eligibility, any sex, with Malaria or Bacterial Co-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.