Monitoring Pregnant Women for Antimalarial Drug Resistance

NCT05072613 | Completed

• 1 other identifier: 548-21
• Study Type: observational
• Target: 6,833
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Antimalarial Drug Resistance

Outcome Measures

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.

  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 Outcomes (2)

• Evaluate the acceptability of the intervention

  12 months

• Compare malaria prevalence in pregnant women with that of in children throughout the year.

  12 months

Study Arms (2)

Pregnant women

Pregnant women attending Antenatal Care Services

Other: Malaria screening

School children

Children attending Primary Schools

Other: Malaria screening

Interventions

Malaria screening OTHER

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

Pregnant women; School children

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Pregnancy OR for children age \<14 years old and in primary school

You may not qualify if:

• Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)

Sponsors & Collaborators

• University of Oxford: lead
• Kinshasa School of Public Health: collaborator
• Wellcome Sanger Institute: collaborator

Study Sites (1)

Kinshasa Medical Oxford Research Unit

Kinsasa, Democratic Republic of the Congo

Location

Related Publications (5)

• 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.

  PMID: 31752889 BACKGROUND

• 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.

  PMID: 31395496 BACKGROUND

• 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.

  PMID: 26296450 BACKGROUND

• 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.

  PMID: 27473039 BACKGROUND

• Onyamboko M, Wasakul V, Bakomba SB, Kayembe DK, Nzambiwishe BK, Ekombolo PE, Badjanga BB, Maindombe JM, Ngavuka JN, Lwadi BN, Drury E, Ariani C, Goncalves S, Chamsukhee V, Waithira N, Verschuuren TD, Lee SJ, Miotto O, Fanello C. Pregnant women as a sentinel population for genomic surveillance of malaria in the Democratic Republic of the Congo: a population-based study. Lancet Glob Health. 2025 Mar;13(3):e479-e487. doi: 10.1016/S2214-109X(24)00497-2.

  PMID: 40021306 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Dried Blood Spot. Only Plasmodium DNA will be analyzed.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 11, 2021
• Study Start: November 11, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)