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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.
The BLOOMy study has two co-Primary objectives:
The secondary objectives are:
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| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical malaria episodes per child-year at risk meeting the primary case definition | 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)) | 6 months |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical malaria episodes per child-year at risk meeting the following secondary cases definition | 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy children aged 1.5 to 12 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe de Recherche Action en Santé | Ouagadougou | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24475198 | Result | Tiono AB, Kangoye DT, Rehman AM, Kargougou DG, Kabore Y, Diarra A, Ouedraogo E, Nebie I, Ouedraogo A, Okech B, Milligan P, Sirima SB. Malaria incidence in children in South-West Burkina Faso: comparison of active and passive case detection methods. PLoS One. 2014 Jan 24;9(1):e86936. doi: 10.1371/journal.pone.0086936. eCollection 2014. | |
| 26185098 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2026 | |
| Reset | Mar 23, 2026 | |
| Release | Mar 31, 2026 | |
| Reset | Apr 20, 2026 | |
| Release | May 22, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2026 | Mar 23, 2026 | |||
| Mar 31, 2026 |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Number of new P. falciparum clones acquired over time |
| 6 months |
| Immune responses to malaria candidate vaccines in the consortium portfolio | 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. | 6 months |
| Guyant P, Corbel V, Guerin PJ, Lautissier A, Nosten F, Boyer S, Coosemans M, Dondorp AM, Sinou V, Yeung S, White N. Past and new challenges for malaria control and elimination: the role of operational research for innovation in designing interventions. Malar J. 2015 Jul 17;14:279. doi: 10.1186/s12936-015-0802-4. |
| 39695728 | Derived | Ouedraogo A, Ouattara D, Ouattara SM, Diarra A, Badoum ES, Hema A, Ouedraogo AZ, Hien D, Bougouma EC, Nebie I, Bocquet V, Vaillant M, Tiono AB, Sirima SB. Evaluating artesunate monotherapy and dihydroartemisinin-piperaquine as potential antimalarial options for prevaccination radical cures during future malaria vaccine field efficacy trials. Malar J. 2024 Dec 18;23(1):377. doi: 10.1186/s12936-024-05198-1. |
| Apr 20, 2026 |
| May 22, 2026 | Jun 17, 2026 |
| Jun 26, 2026 |
| D000079426 |
| Vector Borne Diseases |