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Monitoring Pregnant Women for Antimalarial Drug Resistance

Pregnant Women Attending Antenatal Care Services as a Sentinel Population for Antimalarial Drug Resistance Genetic Surveillance in Africa

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05072613
Acronym
MIRANDA
Enrollment
6833
Registered
2021-10-11
Start date
2021-11-11
Completion date
2023-05-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Antimalarial Drug Resistance

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.

Interventions

OTHERMalaria screening

Participants are screened for malaria and a dried blood spot is collected from malaria positive cases

Sponsors

Kinshasa School of Public Health
CollaboratorOTHER
Wellcome Sanger Institute
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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)

Design outcomes

Primary

MeasureTime frameDescription
Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children.18 monthsPlasmodium 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

MeasureTime frameDescription
Evaluate the acceptability of the intervention12 monthsAcceptability 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.
Compare malaria prevalence in pregnant women with that of in children throughout the year.12 monthsMalaria 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.

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026