MIRANDA: Monitoring Pregnant Women for Antimalarial Drug Resistance

Sponsor
University of Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072613
Collaborator
Kinshasa School of Public Health (Other), Wellcome Sanger Institute (Other)
7,080
1
19.6
361.6

Study Details

Study Description

Brief Summary

Annually, malaria affects an estimated 229 million people, causing 409,000 deaths (WHO 2019) mostly in Africa. Despite a substantial decline in malaria-related maternal and child deaths in recent years, progress in controlling malaria has been slower than anticipated and uneven across countries. COVID-19-related disruption of malaria control activities will likely further slow the pace and lead to an even greater burden in the near future.

One of the greatest challenges delaying progress in malaria elimination is antimalarial drug resistance. Recent reports of the emergence of artemisinin-resistant parasites in parts of Africa are the cause of even greater concern, since the loss of frontline treatment efficacy could bring about a dramatic reversal of progress.

Large-scale genetic surveillance of Plasmodium is an effective tool for rapid detection of changes in drug efficacy, enabling countries to switch to effective preventive and curative treatments when necessary. The implementation of genetic surveillance has proven very successful in small, low malaria burden countries. However, in large, high malaria burden countries such implementation is operationally and economically more complex.

Screening pregnant women attending Antenatal Care (ANC) services can be a practical and economical strategy for estimating malariometric parameters, with fewer limitations and challenges than conventional survey methodologies in children. The present study aims to demonstrate that this is also true for the genetic surveillance of antimalarial drug resistance.

Condition or Disease Intervention/Treatment Phase
  • Other: Malaria screening

Study Design

Study Type:
Observational
Anticipated Enrollment :
7080 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pregnant Women Attending Antenatal Care Services as a Sentinel Population for Antimalarial Drug Resistance Genetic Surveillance in Africa
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Pregnant women

Pregnant women attending Antenatal Care Services

Other: Malaria screening
Participants are screened for malaria and a dried blood spot is collected from malaria positive cases

School children

Children attending Primary Schools

Other: Malaria screening
Participants are screened for malaria and a dried blood spot is collected from malaria positive cases

Outcome Measures

Primary Outcome Measures

  1. Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children. [18 months]

    Plasmodium falciparum from infected individuals will be sequenced and the frequency of antimalarial drug resistance mutations in pregnant women will be compared with that of children.

Secondary Outcome Measures

  1. Evaluate the acceptability of the intervention [12 months]

    Acceptability will be measured as: 1) the number of women who agree to be tested for malaria, over the number of women who attend the ANC service and 2) via a specially designed questionnaire.

  2. Compare malaria prevalence in pregnant women with that of in children throughout the year. [12 months]

    Malaria prevalence will be measured by Rapid Diagnostic Test and standard malaria microscopy in both populations (pregnant women and children) for a period of 12 months and results compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnancy OR for children age <14 years old and in primary school
Exclusion Criteria:
  • Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kinshasa Medical Oxford Research Unit Kinsasa Congo, The Democratic Republic of the

Sponsors and Collaborators

  • University of Oxford
  • Kinshasa School of Public Health
  • Wellcome Sanger Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT05072613
Other Study ID Numbers:
  • 548-21
First Posted:
Oct 11, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Oxford
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021