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NCT Number: NCT04601714

Baseline Cohort Malaria Morbidity Study

The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved.

Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment.

Participants will be followed for a minimum of six months throughout the malaria peak transmission season.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

About this study

The BLOOMy study has two co-Primary objectives:

  • To assess the incidence of clinical malaria meeting the primary case definition in children aged 1.5 to 12 years living in the study area over the main transmission season
  • To assess the occurrence of reinfection following the radical cure of existing parasitemia.

The secondary objectives are:

  • To assess the incidence of clinical malaria meeting various secondary cases definition in children aged 1.5 to 12 years living in the study area over the main transmission season
  • To measure the immune responses (humoral and cell-mediated) to a panel of malaria vaccine candidate antigens
  • To assess the molecular force of infection
  • To pilot and standardize malaria morbidity assessment in three phase 2 malaria vaccine testing sites.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children aged 1.5 to 12 years
  • Residence in the study area or surroundings for the period of the study
  • Written informed consent from parents/legally acceptable representatives and an assent for children

Exclusion criteria

  • Complicated symptomatic malaria (defined according to standard World Health Organization criteria)
  • Anaemia (Hb<8g/dL),
  • Any (chronic) illness that requires immediate clinical care.
  • Family history of sudden death or of congenital or clinical conditions known to prolong QTcB or QTcF interval or e.g. family history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or severe cardiac disease
  • Any treatment which can induce a lengthening of QT interval
  • Known history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolones
  • Receipt of any blood transfusion or immunoglobulins within 3 months
  • Known history of hypersensitivity or allergic reactions to artesunate
  • Severe malnutrition (weight-for-height being below -3 standard deviation or less than 70% of median of the World Health Organization (WHO) normalized reference values).
  • Weight below 5 kg
  • Current or previous participation in malaria vaccine trials
  • Current active participation in any trial involving administration of investigational drug.

Treatment and study plan

Primary outcomes

  1. Number of clinical malaria episodes per child-year at risk meeting the primary case definition

    Time frame: 6 months

    The primary case definition: Positive P. falciparum parasitemia at a density > 0 detected by microscopy associated with measured fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non-contact infrared thermometer))

  2. Time to P. falciparum infection detected by positive thick blood smear within 6 months after the enrolment in African children under natural exposure to P. falciparum by treatment group

    Time frame: 6 months

Secondary outcomes

  1. Number of clinical malaria episodes per child-year at risk meeting the following secondary cases definition

    Time frame: 6 months

    Second Secondary case definition: Measured fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non-contact infrared thermometer) AND parasitemia of >5,000 parasites (p) / μl

  2. Number of new P. falciparum clones acquired over time

    Time frame: 6 months

  3. Immune responses to malaria candidate vaccines in the consortium portfolio

    Time frame: 6 months

    Panel of malaria vaccine candidate's antigens such as PfSPZ CVAC, ME-TRAP, R21 (Pre erythrocytic stage antigens) and PfRH5, NPC-SE36 (Blood stage antigens) will be used to assess antibody responses at day 0 and 28 of confirmed episodes of clinical malaria.

Sponsors and collaborators

Lead sponsor

Groupe de Recherche Action en Sante

Other

Registry information

Official study title

Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites

Acronym: BLOOMy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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