MalariaMIRANDANCT05072613
Monitoring Pregnant Women for Antimalarial Drug Resistance
An observational study of Malaria, run by University of Oxford at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Malaria screening
- How many people
- 6,833 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 11 Nov 2021to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women of all ages and in any trimester of pregnancy, and children <14 years old
Who may be able to join
- Pregnancy OR for children age <14 years old and in primary school
Who cannot join
- Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kinshasa Medical Oxford Research Unit
Kinsasa
About this study
Official title: 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.
Read more
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
- Being tested
- Malaria screening
- Keywords
- Antimalarial Drug Resistance
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria screeningOther
Participants are screened for malaria and a dried blood spot is collected from malaria positive cases
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women attending Antenatal Care Services Receives: Other: Malaria screening | |
| School children | Children attending Primary Schools Receives: Other: Malaria screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start11 Nov 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Kinshasa School of Public Health, Wellcome Sanger Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072613
- Sponsor's protocol ID
- 548-21
- Acronym
- MIRANDA
- Status last verified
- May 2023
- First submitted
- 27 Sep 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31752889Mayor 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.
PubMed 31395496van 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.
PubMed 26296450Willilo 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.
PubMed 27473039Onyamboko 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.
PubMed 40021306
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women Attending Antenatal Care Services as a Sentinel Population for Antimalarial Drug Resistance Genetic Surveillance in Africa
- ClinicalTrials.gov ID
- NCT05072613
- Acronym / sponsor ID
- MIRANDA / 548-21
- Conditions
- Malaria
- Keywords
- Antimalarial Drug Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,833 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Kinshasa School of Public Health, Wellcome Sanger Institute
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Malaria screeningPregnant women attending Antenatal Care Services |
| School children | – | Other: Malaria screeningChildren attending Primary Schools |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women of all ages and in any trimester of pregnancy, and children <14 years old
Key inclusion criteria (1 listed)
- Pregnancy OR for children age <14 years old and in primary school
Key exclusion criteria (1 listed)
- Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malaria screeningParticipants are screened for malaria and a dried blood spot is collected from malaria positive cases | Other | Pregnant women, School children |
Primary outcome
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.
2 secondary outcomes
Evaluate the acceptability of the intervention
Time frame: 12 months
Compare malaria prevalence in pregnant women with that of in children throughout the year.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 31752889Brunner 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.
- Background: PubMed 31395496Mayor 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.
- Background: PubMed 26296450van 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.
- Background: PubMed 27473039Willilo 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.
- Derived from this study: PubMed 40021306Onyamboko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by University of Oxford at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072613, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.