Clinical trial NCT05072613: Monitoring Pregnant Women for Antimalarial Drug Resistance
Official title: Pregnant Women Attending Antenatal Care Services as a Sentinel Population for Antimalarial Drug Resistance Genetic Surveillance in Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Keywords: Antimalarial Drug Resistance
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
name: Wellcome Sanger Institute
First posted: 2021-10-11
Enrollment: 6833
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women of all ages and in any trimester of pregnancy, and children \<14 years old

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children.
timeFrame: 18 months
Secondary outcomes:
measure: Evaluate the acceptability of the intervention
timeFrame: 12 months
measure: Compare malaria prevalence in pregnant women with that of in children throughout the year.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kinsasa
country: Congo, The Democratic Republic of the
facility: Kinshasa Medical Oxford Research Unit
Study officials:
References:
citation: 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.
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.
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.
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.