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Malaria Birth Cohort (MBC)

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ClinicalTrials.gov Identifier: NCT04050566
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Kwame Nkrumah University of Science and Technology
Kumasi Centre for Collaborative Research (KCCR)
Heidelberg University
KEMRI-Wellcome Trust Collaborative Research Program
Agogo Presbyterian Hospital
Information provided by (Responsible Party):
Dr. Jürgen May, Bernhard Nocht Institute for Tropical Medicine

Brief Summary:

Aim od the study is the investigation of immunity development against malaria with regards to parasite, human, and socio-economic factors.

In detail, the objectives are as follows:

  • Analysis of temporal changes of immune cell phenotypes, their correlation with protection and pathology
  • Analysis of temporal changes of humoral immune responses, their correlation with protection and pathology, and analysis of protective antibody responses over time
  • Analysis of malaria specific autoantibody profiles at time of birth (T=0) compared to after completion of first year of life and their association with disease outcome
  • Analysis of parasite diversity during different malaria episodes in the first year of life
  • Analysis of the influence of malaria infection on human endothelial activation
  • Analysis of development, composition, diversity, and richness of intestinal microbiota from birth to 12 months and its relationship to occurrence and severity of malaria
  • Analysis of behavioural, socio-economic and environmental factors and pathways associated with malaria in children

The study is planned as a prospective birth cohort. Pregnant women will be recruited in the study hospital during antenatal care visits over a period of twelve months to account for seasonal fluctuations in disease prevalence. Children will be passively followed for 12 months at regular vaccination visits in the frame of the EPI schedule (WHO Expanded Program of Immunization), which are organised by the health facilities in the district according to a fixed schedule. The participant's household will be visited within the first six weeks after birth to conduct questionnaires and record residential GPS coordinates. An additional visit is scheduled for 12 months after birth for a last follow-up visit. Parents and primary caregivers are encouraged to bring their child to the study hospital in case of a fever episode for an examination and treatment.


Condition or disease
Malaria

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Anti-malarial Immunity Development, Parasite Diversity, Endothelial Cell Activation, the Influence of Microbiota, and Behavioural and Socio-economic Risk Factors in Early Life
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. First severe malaria episode [ Time Frame: First year of life ]
    Severe Malaria episode as defined by the WHO measured by microscopy and PCR



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women during the third trimester of pregnancy visiting Agogo Prespyterian Hospital (APH) for their antenatel care visit.
Criteria

Inclusion Criteria:

  • Catchment area of the EPI (Expanded Program of Immunization) centres with good accessibility to Agogo Prespyterian Hospital (APH)
  • Willingness and able to give informed consent

Exclusion Criteria:

  • Maternal age <18 years
  • Positive HIV status of mother
  • Refusal or withdrawal of informed consent

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): NCT04050566


Contacts
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Contact: Daniel Eibach, MD +49 40 42818-0 ext 504 eibach@bnitm.de
Contact: Eva Mertens, PhD +49 40 42818-0 ext 243 mertens@bnitm.de

Locations
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Germany
Bernhard Nocht Institute for Tropical Medicine Recruiting
Hamburg, Germany, 20359
Ghana
Kwame Nkrumah University of Science and Technology Recruiting
Kumasi, Ghana
Contact: John Amuasi, Dr       amuasi@kccr.de   
Contact: Oumou Maige-Ascofaré, PhD       maiga@bnitm.de   
Sponsors and Collaborators
Bernhard Nocht Institute for Tropical Medicine
Kwame Nkrumah University of Science and Technology
Kumasi Centre for Collaborative Research (KCCR)
Heidelberg University
KEMRI-Wellcome Trust Collaborative Research Program
Agogo Presbyterian Hospital
Investigators
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Principal Investigator: Jürgen May, Prof Bernhard Nocht Institute for Tropical Medicine
Publications:

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Responsible Party: Dr. Jürgen May, Professor, Department Head, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier: NCT04050566    
Other Study ID Numbers: PV5940
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Dr. Jürgen May, Bernhard Nocht Institute for Tropical Medicine:
Malaria
Immunity development
Plasmodium diversity
Microbiota
Endothelial cell activation
Poverty
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases