Monitoring Pregnant Women for Antimalarial Drug Resistance (MIRANDA)

December 5, 2023 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6833

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women of all ages and in any trimester of pregnancy, and children <14 years old

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Kinshasa School of Public Health
Wellcome Sanger Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 548-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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