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Plasmodium Falciparum MalariaPhase 3ASSERMalariaNCT04147546

Additional Screening With Sensitives RDTs and Malaria

A Phase 3 study testing Additional screening using ultra sensitive RDTs, Dihydroartemisinin-piperaquin and Reminders in people with Plasmodium Falciparum Malaria and Malaria Diagnosis, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in… Read more about this study

Who is it for?
Ages 16 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Additional screening using ultra sensitive RDTs, Dihydroartemisinin-piperaquin and Reminders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
1 siteBurkina Faso
Study dates
31 Aug 2020to 31 Dec 2021
Phase
Phase 3
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 16 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Gestational age of 16 to 24 weeks at their first booking
  • At least (≥) 16 years old
  • Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery
  • Willing to deliver at the health facility
  • Willing to provide biological samples as and when required during the study period (blood and placental biopsy)
  • Ability to provide written informed consent

Who cannot join

  • A history of sensitivity to sulphonamides or to any of the study drugs;
  • History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
  • History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
  • Any significant illness at the time of screening that requires hospitalization, including severe malaria;
  • Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
  • Prior enrolment in the study or concurrent enrolment in another study.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro

    Ouagadougou, Kadiogo, 218 CMS 11

Other trials in Burkina Faso

About this study

Official title: Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For the latter, 3 or more doses are recommended by the national malaria control program (NMCP) but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by perceptions, acceptability and contextual factors that need to be understood and therefore improve the effectiveness of this health interventions. In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many malaria cases are missed in pregnant women due to the power performance of recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT could improve the outcome of the pregnancy in addition to IPTp-SP.

Read the detailed description

MiP remains a major public health issue in Burkina Faso, which would compromise the achievement of Sustainable Development Goals for maternal and child health (22). Malaria control program have been implemented by the Burkinabe Ministry of Health (MoH) since 2000; nevertheless, lower coverage and delays in implementation of these programs may have reduced their effectiveness.

In Burkina Faso, recommended preventions strategies for malaria imply the administration of at least 3 doses of IPTp during ANCs and before delivery (23). IPTp have been proven to have a great impact on PM, LBW and peripheral malaria infection at delivery so increasing the number of IPTp doses given is a priority. Strategies to increase the number of IPTp doses and the coverage using reminders could improve this health intervention effectiveness. This can be considered as follow up of the Cosmic study (24) recommendations.

However with increasing drug resistance, there is a progressively diminished efficacy of IPTp-SP in clearing existing infections and a shortening of the post-treatment prophylaxis period (25). Moreover, pregnant women can generally be infected with low parasites densities between ANCs compromising the outcome of the pregnancy (26). Therefore, additional screening with HS-RDTs between ANCs and treatment using ACTs with long Post-treatment prophylaxis effect in addition to IPTp-SP could have a great impact both for the mothers and their offspring's.

This proposal aims to determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on placental malaria (PM) and low birth weight (LBW) in a context of IPTp-SP, in rural central Burkina Faso. The findings obtained from this study will help to assist the MoH in the implementation of the appropriate interventions in this group at risk.

Objectives

General objective

  • To determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in in Burkina Faso

Specific objectives are the following:

  • To determine the gain of additional screening with HS-RDTs and treatment with DP against PM, LBW and peripheral malaria infection at delivery
  • To assess the determinants of the poor coverage and improve the number of IPTp doses received using phone call or SMS as a reminder
Being tested
Additional screening using ultra sensitive RDTs, Dihydroartemisinin-piperaquin, Reminders
Medical subject headings
Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional screening using ultra sensitive RDTsDiagnostic test

    Also called Malaria Ag Pf ultra-sensitive RDT

    At each ANC visit, study nurses will perform an HS-RDT for participants in the intervention arm

  • Dihydroartemisinin-piperaquinDrug

    All pregnant women with a positive HS-RDT will be treated with a full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home

  • RemindersOther

    Before each scheduled ANC visit, reminders using SMS or phone call will be used. This is order to increase ANC attendance

Study groups in NCT04147546
Study groupRoleWhat they receive
Intervention armExperimentalA full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home. At each ANC visit, study nurses will perform an HS-RDT for participants in this arm. Reminders will be sent in this group in order to improve IPTp-SP uptake
Receives: Diagnostic Test: Additional screening using ultra sensitive RDTs; Drug: Dihydroartemisinin-piperaquin; Other: Reminders
Control armNo interventionA full course of artemether-lumefantrine (AL) over 3 days. The first dose of AL will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home. At each ANC visit, study nurses will perform a conventional RDT for participants in this arm if the participant have symptoms suggestive of malaria. No reminder will be sent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placental malaria prevalence

    The prevalence of placental malaria infection will be determined in the two arms. Placentas will be identified as not infected (no evidence of parasite or pigment); active infection (presence of parasites and pigment) and chronic infection (absence of parasites and presence of pigment)

    Measured: 36 months

  2. Low birthweight prevalence

    The prevalence of low birthweight (defined as birth weight less than 2,500 g) will be compared between the two arms.

    Measured: 36 months

  3. Peripheral maternal malaria infection prevalence

    At delivery, malaria will be diagnosed using peripheral thick smears. Parasite density will be estimated by counting the number of asexual parasites per 200 leukocytes in the thick blood film and assuming white blood cells (WBC) count of 8,000/μl

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start31 Aug 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147546
Sponsor's protocol ID
NCT04147546
Acronym
ASSERMalaria
Status last verified
Mar 2023
First submitted
14 Oct 2019
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: In accordance to the EDCTP2 grant agreement, all data generated through this study will be shared in order to allow for third parties to access, mine, exploit, reproduce and disseminate, free of charge

Publications

  • Dellicour S, Tatem AJ, Guerra CA, Snow RW, ter Kuile FO. Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study. PLoS Med. 2010 Jan 26;7(1):e1000221. doi: 10.1371/journal.pmed.1000221.

    PubMed 20126256

  • Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, Newman RD. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):93-104. doi: 10.1016/S1473-3099(07)70021-X.

    PubMed 17251080

  • COSMIC Consortium. Community-based Malaria Screening and Treatment for Pregnant Women Receiving Standard Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: A Multicenter (The Gambia, Burkina Faso, and Benin) Cluster-randomized Controlled Trial. Clin Infect Dis. 2019 Feb 1;68(4):586-596. doi: 10.1093/cid/ciy522.

    PubMed 29961848

  • Radeva-Petrova D, Kayentao K, ter Kuile FO, Sinclair D, Garner P. Drugs for preventing malaria in pregnant women in endemic areas: any drug regimen versus placebo or no treatment. Cochrane Database Syst Rev. 2014 Oct 10;2014(10):CD000169. doi: 10.1002/14651858.CD000169.pub3.

    PubMed 25300703

  • van Eijk AM, Hill J, Larsen DA, Webster J, Steketee RW, Eisele TP, ter Kuile FO. Coverage of intermittent preventive treatment and insecticide-treated nets for the control of malaria during pregnancy in sub-Saharan Africa: a synthesis and meta-analysis of national survey data, 2009-11. Lancet Infect Dis. 2013 Dec;13(12):1029-42. doi: 10.1016/S1473-3099(13)70199-3. Epub 2013 Sep 18.

    PubMed 24054085

  • Gutman J, Kalilani L, Taylor S, Zhou Z, Wiegand RE, Thwai KL, Mwandama D, Khairallah C, Madanitsa M, Chaluluka E, Dzinjalamala F, Ali D, Mathanga DP, Skarbinski J, Shi YP, Meshnick S, ter Kuile FO. The A581G Mutation in the Gene Encoding Plasmodium falciparum Dihydropteroate Synthetase Reduces the Effectiveness of Sulfadoxine-Pyrimethamine Preventive Therapy in Malawian Pregnant Women. J Infect Dis. 2015 Jun 15;211(12):1997-2005. doi: 10.1093/infdis/jiu836. Epub 2015 Jan 6.

    PubMed 25564249

  • Ruizendaal E, Tahita MC, Geskus RB, Versteeg I, Scott S, d'Alessandro U, Lompo P, Derra K, Traore-Coulibaly M, de Jong MD, Schallig HDFH, Tinto H, Mens PF. Increase in the prevalence of mutations associated with sulfadoxine-pyrimethamine resistance in Plasmodium falciparum isolates collected from early to late pregnancy in Nanoro, Burkina Faso. Malar J. 2017 Apr 28;16(1):179. doi: 10.1186/s12936-017-1831-y.

    PubMed 28454537

  • Kakuru A, Jagannathan P, Muhindo MK, Natureeba P, Awori P, Nakalembe M, Opira B, Olwoch P, Ategeka J, Nayebare P, Clark TD, Feeney ME, Charlebois ED, Rizzuto G, Muehlenbachs A, Havlir DV, Kamya MR, Dorsey G. Dihydroartemisinin-Piperaquine for the Prevention of Malaria in Pregnancy. N Engl J Med. 2016 Mar 10;374(10):928-39. doi: 10.1056/NEJMoa1509150.

    PubMed 26962728

  • Hofmann NE, Gruenberg M, Nate E, Ura A, Rodriguez-Rodriguez D, Salib M, Mueller I, Smith TA, Laman M, Robinson LJ, Felger I. Assessment of ultra-sensitive malaria diagnosis versus standard molecular diagnostics for malaria elimination: an in-depth molecular community cross-sectional study. Lancet Infect Dis. 2018 Oct;18(10):1108-1116. doi: 10.1016/S1473-3099(18)30411-0. Epub 2018 Aug 28.

    PubMed 30170986

  • Das S, Jang IK, Barney B, Peck R, Rek JC, Arinaitwe E, Adrama H, Murphy M, Imwong M, Ling CL, Proux S, Haohankhunnatham W, Rist M, Seilie AM, Hanron A, Daza G, Chang M, Nakamura T, Kalnoky M, Labarre P, Murphy SC, McCarthy JS, Nosten F, Greenhouse B, Allauzen S, Domingo GJ. Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections. Am J Trop Med Hyg. 2017 Nov;97(5):1540-1550. doi: 10.4269/ajtmh.17-0245. Epub 2017 Aug 18.

    PubMed 28820709

  • Vasquez AM, Medina AC, Tobon-Castano A, Posada M, Velez GJ, Campillo A, Gonzalez IJ, Ding X. Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia. PLoS One. 2018 Aug 2;13(8):e0201769. doi: 10.1371/journal.pone.0201769. eCollection 2018.

    PubMed 30071004

  • Tahita MC, Sondo P, Kabore B, Ilboudo H, Rouamba T, Sanou H, Ouedraogo K, Compaore A, Lompo P, Ouedraogo F, Sawadogo S, Derra K, Sawadogo YE, Some AM, Nana M, Sorgho H, Traore-Coulibaly M, Bassat Q, Tinto H. Impact and operational feasibility of adding malaria infection screening using an ultrasensitive RDT for placental and fetal outcomes in an area of high IPTP-SP coverage in Burkina Faso: the ASSER MALARIA pilot study protocol. Pilot Feasibility Stud. 2022 Oct 1;8(1):221. doi: 10.1186/s40814-022-01181-2.

    PubMed 36183100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Additional screening using ultra sensitive RDTs, Dihydroartemisinin-piperaquin and Reminders in people with Plasmodium Falciparum Malaria and Malaria Diagnosis, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.

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 6 inclusion and 6 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 30 Mar 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 Burkina Faso. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Placental malaria prevalence (time frame: 36 months). The study lists 3 primary outcomes in all. 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 NCT04147546, which also lists 12 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 30 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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