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OpenTrials
Completed

NCT Number: NCT05072613

Monitoring Pregnant Women for Antimalarial Drug Resistance

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinshasa Medical Oxford Research Unit

Kinsasa, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Malaria screening

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Evaluate the acceptability of the intervention

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Kinshasa School of Public Health
  • Wellcome Sanger Institute

Registry information

Official study title

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

Acronym: MIRANDA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2021
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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