Baseline Cohort Malaria Morbidity Study

NCT04601714 | Completed

• 1 other identifier: Protocol_BLOOMy study
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Malaria; Cohort; Children; Epidemiology

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

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

  6 months

• Number of new P. falciparum clones acquired over time

  6 months

• Immune responses to malaria candidate vaccines in the consortium portfolio

  6 months

Eligibility Criteria

• Age: 18 Months - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy children aged 1.5 to 12 years

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe de Recherche Action en Sante: lead

Study Sites (1)

Groupe de Recherche Action en Santé

Ouagadougou, Burkina Faso

Location

Related Publications (3)

• 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.

  PMID: 24475198 RESULT

• 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.

  PMID: 26185098 RESULT

• 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.

  PMID: 39695728 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, BA, PhD

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 7, 2020
• Primary Completion: September 28, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

BU (1)