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Malaria,FalciparumPhase 4INTREPiDNCT05757167

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

A Phase 4 study testing Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) and Artemether-lumefantrine (AL) in people with Malaria,Falciparum and Malaria in Pregnancy, run by Duke University at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth… Read more about this study

Who is it for?
Ages 16 to 40 years, women only
What is being tested?
Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) and Artemether-lumefantrine (AL)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,174 participants
Where
2 sitesin 2 countries
Study dates
6 Nov 2023to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 40 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged between 16 years and 40 years (inclusive)
  • Viable singleton pregnancy with gestational age estimated less than 13 6/7 weeks (inclusive) by ultrasound
  • HIV-uninfected
  • Willing to participate in the study schedule
  • Planning to remain in the study area for the duration of pregnancy and 1 month after delivery
  • Willing to deliver in a study-affiliated health facility

Who cannot join

  • High risk pregnancy that requires referral for specialized care by local guidelines
  • Active medical problem at the time of screening requiring higher level care
  • Antimalarial receipt in the 2 weeks prior to screening
  • Past allergy to Artemether or Lumefantrine or another condition that prohibits the receipt of either drug
  • Current participation in another clinical research study

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Democratic Republic of the Congo1 site

  • Kinshasa School of Public Health

    Kinshasa

Other trials in Democratic Republic of the Congo

Kenya1 site

  • Moi University

    Eldoret

Other trials in Kenya

About this study

Official title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.

Read the detailed description

INTREPiD is a two-arm, open-label, parallel-assignment randomized trial of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test (HS-RDT). Participants will be women of all gravidities presenting to antenatal clinics in the 1st trimester in sites endemic for P. falciparum malaria in Kenya and the Democratic Republic of the Congo.

Following consent and enrollment, women will be allocated 1:1 to either usual antenatal care or to the intervention. The intervention will be a single screening in the 1st trimester for P. falciparum infection in maternal peripheral blood with a HS-RDT. Women who test positive for P. falciparum on HS-RDT testing will be treated with a single course of Artemether-Lumefantrine (AL) and then returned to usual antenatal care.

Participants will be followed through delivery and then through their offspring's first month of life.

The Hypothesis is that, compared to usual antenatal care, screening women in the 1st trimester for P. falciparum and treating them if positive with AL will reduce the risk of an adverse pregnancy outcome.

Being tested
Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
Medical subject headings
Malaria, Falciparum, Stillbirth, Premature Birth

What participants receive

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

  • Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)Diagnostic test

    Also called NxTek™ Eliminate Malaria P.f, 05FK140 (Global), 05FK141 (Global), 05FK142 (Global)

    Detection of Plasmodium falciparum HRP-II antigen1

    Method: Lateral Flow; Time to Result: 20 minutes; Sample Type: Fingerstick Whole Blood; Sample Volume: 5µl; Storage Conditions: 1-30°C; Shelf Life: 12 months; Sensitivity/Specificity: 99.0%/98.6%

  • Artemether-lumefantrine (AL)Drug

    Also called AL

    oral tablets: 6 doses of 80/480 mg over 3 days

Study groups in NCT05757167
Study groupRoleWhat they receive
HS-RDT screening/AL treatmentExperimentalPregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
Receives: Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT); Drug: Artemether-lumefantrine (AL)
Usual antenatal careNo interventionPregnant women will receive usual antenatal care

What is being measured

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

  1. Composite number of adverse pregnancy outcomes

    Adverse pregnancy outcomes defined as low birth weight (<2500 grams) OR preterm (< 37 0/7 weeks) OR small for gestational age (GA) (< 10th percentile weight for GA) OR pregnancy loss, defined as a. spontaneous abortion ( loss < 22 0/7 weeks gestation) OR b. stillbirth (loss ≥ 22 0/7 weeks gestation) OR neonatal death (livebirth with death prior to the 28th day of life).

    Measured: Enrollment to 28 days Post-delivery (including each antenatal care visit)

Secondary outcomes (18)

  1. Birthweight

    Birthweight in grams

    Measured: Delivery

  2. Number of infants with low birthweight

    < 2500 grams, livebirth

    Measured: Delivery

  3. Gestational age (GA)

    GA at delivery in weeks/days, livebirth

    Measured: Delivery

  4. Preterm

    < 37 0/7 weeks, livebirth

    Measured: Delivery

  5. Number of infants that are small for gestational age

    Weight for gestational age < 10th percentile, livebirth

    Measured: Delivery

  6. Number of adverse newborn outcomes

    low birthweight OR preterm OR small for gestational age

    Measured: Delivery

  7. Number of spontaneous abortions

    Pregnancy loss < 22 0/7 weeks gestation

    Measured: Delivery

  8. Number of stillbirths

    Pregnancy loss ≥ 22 0/7 weeks gestation

    Measured: Delivery

  9. Number of early fetal deaths

    Pregnancy loss 22 0/7 - 27 6/7 weeks gestation

    Measured: Delivery

  10. Number of late fetal deaths

    Pregnancy loss ≥ 28 0/7 weeks gestation

    Measured: Delivery

  11. Number of pregnancy losses

    Spontaneous abortion OR stillbirth

    Measured: Delivery

  12. Number of neonatal deaths

    Before the 28th day of life, livebirth

    Measured: Delivery to 28 days Post-delivery

  13. Number of perinatal deaths

    Late fetal death OR Neonatal death

    Measured: Delivery to 28 days Post-delivery

  14. Incidence of clinical malaria during pregnancy

    Maternal symptoms with peripheral malaria parasitemia detected by light microscopy or rapid diagnostic test

    Measured: Enrollment to Delivery (including each antenatal care visit)

  15. Number of mothers with peripheral parasitemia at delivery

    Maternal peripheral parasitemia at delivery by PCR

    Measured: Delivery

  16. Mean maternal hemoglobin concentration

    Maternal hemoglobin (g/dL)

    Measured: Enrollment and Delivery

  17. Number of mothers with anemia at delivery

    Maternal Hb concentration ≤ 11 g/dL

    Measured: Delivery

  18. Number of mothers with severe anemia at delivery

    Maternal Hb concentration ≤ 7 g/dL

    Measured: Delivery

Timeline

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

  1. First posted7 Mar 2023
  2. Study start6 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random assignment to either a) usual antenatal care or b) testing for malaria with a high-sensitivity rapid diagnostic test followed by treatment with artemether-lumefantrine if tested positive
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05757167
Sponsor's protocol ID
Pro00110771
Other IDs
1U01AI162463-01A1, 5U01AI162463-02, 5U01AI162463-03, 5U01AI162463-04
Acronym
INTREPiD
Status last verified
May 2026
First submitted
24 Feb 2023
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19.

    PubMed 24853593

  • Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31.

    PubMed 29396010

  • Lawn JE, Blencowe H, Waiswa P, Amouzou A, Mathers C, Hogan D, Flenady V, Froen JF, Qureshi ZU, Calderwood C, Shiekh S, Jassir FB, You D, McClure EM, Mathai M, Cousens S; Lancet Ending Preventable Stillbirths Series study group; Lancet Stillbirth Epidemiology investigator group. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet. 2016 Feb 6;387(10018):587-603. doi: 10.1016/S0140-6736(15)00837-5. Epub 2016 Jan 19.

    PubMed 26794078

  • van Eijk AM, Larsen DA, Kayentao K, Koshy G, Slaughter DEC, Roper C, Okell LC, Desai M, Gutman J, Khairallah C, Rogerson SJ, Hopkins Sibley C, Meshnick SR, Taylor SM, Ter Kuile FO. Effect of Plasmodium falciparum sulfadoxine-pyrimethamine resistance on the effectiveness of intermittent preventive therapy for malaria in pregnancy in Africa: a systematic review and meta-analysis. Lancet Infect Dis. 2019 May;19(5):546-556. doi: 10.1016/S1473-3099(18)30732-1. Epub 2019 Mar 25.

    PubMed 30922818

  • Gonzalez R, Mombo-Ngoma G, Ouedraogo S, Kakolwa MA, Abdulla S, Accrombessi M, Aponte JJ, Akerey-Diop D, Basra A, Briand V, Capan M, Cot M, Kabanywanyi AM, Kleine C, Kremsner PG, Macete E, Mackanga JR, Massougbodgi A, Mayor A, Nhacolo A, Pahlavan G, Ramharter M, Ruperez M, Sevene E, Vala A, Zoleko-Manego R, Menendez C. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. PLoS Med. 2014 Sep 23;11(9):e1001733. doi: 10.1371/journal.pmed.1001733. eCollection 2014 Sep.

    PubMed 25247709

  • Divala TH, Mungwira RG, Mawindo PM, Nyirenda OM, Kanjala M, Ndaferankhande M, Tsirizani LE, Masonga R, Muwalo F, Boudova S, Potter GE, Kennedy J, Goswami J, Wylie BJ, Muehlenbachs A, Ndovie L, Mvula P, Mbilizi Y, Tomoka T, Laufer MK. Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial. Lancet Infect Dis. 2018 Oct;18(10):1097-1107. doi: 10.1016/S1473-3099(18)30415-8. Epub 2018 Sep 5.

    PubMed 30195996

  • Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.

    PubMed 27326859

  • Tagbor H, Bruce J, Agbo M, Greenwood B, Chandramohan D. Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: a randomised controlled non-inferiority trial. PLoS One. 2010 Dec 28;5(12):e14425. doi: 10.1371/journal.pone.0014425.

    PubMed 21203389

  • Madanitsa M, Kalilani L, Mwapasa V, van Eijk AM, Khairallah C, Ali D, Pace C, Smedley J, Thwai KL, Levitt B, Wang D, Kang'ombe A, Faragher B, Taylor SM, Meshnick S, Ter Kuile FO. Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial. PLoS Med. 2016 Sep 13;13(9):e1002124. doi: 10.1371/journal.pmed.1002124. eCollection 2016 Sep.

    PubMed 27622558

  • Desai M, Gutman J, L'lanziva A, Otieno K, Juma E, Kariuki S, Ouma P, Were V, Laserson K, Katana A, Williamson J, ter Kuile FO. Intermittent screening and treatment or intermittent preventive treatment with dihydroartemisinin-piperaquine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for the control of malaria during pregnancy in western Kenya: an open-label, three-group, randomised controlled superiority trial. Lancet. 2015 Dec 19;386(10012):2507-19. doi: 10.1016/S0140-6736(15)00310-4. Epub 2015 Sep 28.

    PubMed 26429700

  • Kajubi R, Ochieng T, Kakuru A, Jagannathan P, Nakalembe M, Ruel T, Opira B, Ochokoru H, Ategeka J, Nayebare P, Clark TD, Havlir DV, Kamya MR, Dorsey G. Monthly sulfadoxine-pyrimethamine versus dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnancy: a double-blind, randomised, controlled, superiority trial. Lancet. 2019 Apr 6;393(10179):1428-1439. doi: 10.1016/S0140-6736(18)32224-4. Epub 2019 Mar 22.

    PubMed 30910321

  • 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

  • Desai M, Gutman J, Taylor SM, Wiegand RE, Khairallah C, Kayentao K, Ouma P, Coulibaly SO, Kalilani L, Mace KE, Arinaitwe E, Mathanga DP, Doumbo O, Otieno K, Edgar D, Chaluluka E, Kamuliwo M, Ades V, Skarbinski J, Shi YP, Magnussen P, Meshnick S, Ter Kuile FO. Impact of Sulfadoxine-Pyrimethamine Resistance on Effectiveness of Intermittent Preventive Therapy for Malaria in Pregnancy at Clearing Infections and Preventing Low Birth Weight. Clin Infect Dis. 2016 Feb 1;62(3):323-333. doi: 10.1093/cid/civ881. Epub 2015 Oct 20.

    PubMed 26486699

  • Leuba SI, Westreich D, Bose CL, Powers KA, Olshan A, Taylor SM, Tshefu A, Lokangaka A, Carlo WA, Chomba E, Liechty EA, Bucher SL, Esamai F, Jessani S, Saleem S, Goldenberg RL, Moore J, Nolen T, Hemingway-Foday J, McClure EM, Koso-Thomas M, Derman RJ, Hoffman M, Bauserman M. Predictors of Plasmodium falciparum Infection in the First Trimester Among Nulliparous Women From Kenya, Zambia, and the Democratic Republic of the Congo. J Infect Dis. 2022 Jun 1;225(11):2002-2010. doi: 10.1093/infdis/jiab588.

    PubMed 34888658

  • Jafari-Guemouri S, Courtois L, Mama A, Rouas B, Neto Braga G, Accrombessi M, Massougbodji A, Ding XC, Tuikue Ndam N, Fievet N, Briand V. A Genotyping Study in Benin Comparing the Carriage of Plasmodium falciparum Infections Before Pregnancy and in Early Pregnancy: Story of a Persistent Infection. Clin Infect Dis. 2021 Jul 15;73(2):e355-e361. doi: 10.1093/cid/ciaa841.

    PubMed 32569359

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) and Artemether-lumefantrine (AL) in people with Malaria,Falciparum and Malaria in Pregnancy, run by Duke University at 2 sites in 2 countries.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo, Kenya. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Composite number of adverse pregnancy outcomes (time frame: Enrollment to 28 days Post-delivery (including each antenatal care visit)). 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 NCT05757167, which also lists 57 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 Oct 2026.

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