MalariaBLOOMyNCT04601714
Baseline Cohort Malaria Morbidity Study
An observational study of Malaria, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months to 12 years
- Conditions the study is for
- Malaria
- How many people
- 459 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 7 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 12 years
- All sexes
- Child
Study population: Healthy children aged 1.5 to 12 years
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites
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.
Read the detailed description
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.
- Conditions
- Malaria
- Keywords
- Malaria, Cohort, Children, Epidemiology
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
Number of new P. falciparum clones acquired over time
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start7 Sep 2020
- Primary completion28 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe de Recherche Action en Sante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiomon B.Sirima, Groupe de Recherche Action en Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601714
- Sponsor's protocol ID
- Protocol_BLOOMy study
- Acronym
- BLOOMy
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24475198Guyant 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.
PubMed 26185098Ouedraogo 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.
PubMed 39695728
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites
- ClinicalTrials.gov ID
- NCT04601714
- Acronym / sponsor ID
- BLOOMy / Protocol_BLOOMy study
- Conditions
- Malaria
- Keywords
- Malaria, Cohort, Children, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Groupe de Recherche Action en SanteUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Healthy children aged 1.5 to 12 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
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
3 secondary outcomes
Number of clinical malaria episodes per child-year at risk meeting the following secondary cases definition
Time frame: 6 months
Number of new P. falciparum clones acquired over time
Time frame: 6 months
Immune responses to malaria candidate vaccines in the consortium portfolio
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Results publication: PubMed 24475198Tiono 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.
- Results publication: PubMed 26185098Guyant 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.
- Derived from this study: PubMed 39695728Ouedraogo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Groupe de Recherche Action en Sante at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical malaria episodes per child-year at risk meeting the primary case definition (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04601714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.