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Trial record 2 of 4 for:    PfRH5

Baseline Cohort Malaria Morbidity Study (BLOOMy)

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ClinicalTrials.gov Identifier: NCT04601714
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sodiomon B.Sirima, Groupe de Recherche Action en Sante

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.


Condition or disease
Malaria

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.

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Study Type : Observational
Estimated Enrollment : 464 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : September 28, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Healthy children aged 1.5 to 12 years
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601714


Contacts
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Contact: Alfred Tiono, MD, PhD +226 70285726 a.tiono@gras.bf
Contact: Alphonse Ouedraogo, MD, PhD +226 70140811 a.ouedraogo@gras.bf

Locations
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Burkina Faso
Groupe de Recherche Action en Santé Recruiting
Ouagadougou, Burkina Faso
Contact: Sodiomon B. Sirima, MD, BA, PhD    +22670200444    s.sirima@gras.bf   
Contact: Alfred B. Tiono, MD, PhD    +22670285726    a.tiono@gras.bf   
Sponsors and Collaborators
Groupe de Recherche Action en Sante
Publications of Results:
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Responsible Party: Sodiomon B.Sirima, MD, BA, PhD, Groupe de Recherche Action en Sante
ClinicalTrials.gov Identifier: NCT04601714    
Other Study ID Numbers: Protocol_BLOOMy study
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sodiomon B.Sirima, Groupe de Recherche Action en Sante:
Malaria
Cohort
Children
Epidemiology
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases