Monitoring Pregnant Women for Antimalarial Drug Resistance

Malaria Clinical Trial

— MIRANDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072613
• Other study ID #: 548-21
• Status: Completed
• Start date: November 11, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6833
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Kinshasa Medical Oxford Research Unit	Kinsasa

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Kinshasa School of Public Health, Wellcome Sanger Institute

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

References & Publications (4)

Brunner NC, Chacky F, Mandike R, Mohamed A, Runge M, Thawer SG, Ross A, Vounatsou P, Lengeler C, Molteni F, Hetzel MW. The potential of pregnant women as a sentinel population for malaria surveillance. Malar J. 2019 Nov 21;18(1):370. doi: 10.1186/s12936-019-2999-0. — View Citation

Mayor A, Menendez C, Walker PGT. Targeting Pregnant Women for Malaria Surveillance. Trends Parasitol. 2019 Sep;35(9):677-686. doi: 10.1016/j.pt.2019.07.005. Epub 2019 Aug 5. — View Citation

van Eijk AM, Hill J, Noor AM, Snow RW, ter Kuile FO. Prevalence of malaria infection in pregnant women compared with children for tracking malaria transmission in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Glob Health. 2015 Oct;3(10):e617-28. doi: 10.1016/S2214-109X(15)00049-2. Epub 2015 Aug 19. — View Citation

Willilo RA, Molteni F, Mandike R, Mugalura FE, Mutafungwa A, Thadeo A, Benedictor E, Kafuko JM, Kaspar N, Ramsan MM, Mwaipape O, McElroy PD, Gutman J, Colaco R, Reithinger R, Ngondi JM. Pregnant women and infants as sentinel populations to monitor prevalence of malaria: results of pilot study in Lake Zone of Tanzania. Malar J. 2016 Jul 29;15(1):392. doi: 10.1186/s12936-016-1441-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children.	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	Evaluate the acceptability of the intervention	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
Secondary	Compare malaria prevalence in pregnant women with that of in children throughout the year.	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