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

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ClinicalTrials.gov Identifier: NCT05757167
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : January 24, 2024
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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 weight, small for gestational age, preterm, fetal loss, or neonatal death.

Condition or disease Intervention/treatment Phase
Malaria,Falciparum Malaria in Pregnancy Malaria in Childbirth Pregnancy Neonatal Health Low Birthweight Stillbirth Gestational Age and Weight Conditions Preterm Birth Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
Actual Study Start Date : November 6, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HS-RDT screening/AL treatment
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
 Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)

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%

Other Names:
  • NxTek™ Eliminate Malaria P.f
  • 05FK140 (Global)
  • 05FK141 (Global)
  • 05FK142 (Global)
  • 05FK143 (Global)
  • Alere Malaria Ag P.f

Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet
oral tablets: 6 doses of 80/480 mg over 3 days
Other Names:
  • AL
  • Coartem
No Intervention: Usual antenatal care
Pregnant women will receive usual antenatal care


Outcome Measures
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Primary Outcome Measures :
  1. Composite number of adverse pregnancy outcomes [ Time Frame: Enrollment to 28 days Post-delivery (including each antenatal care visit) ]
    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).


Secondary Outcome Measures :
  1. Birthweight [ Time Frame: Delivery ]
    Birthweight in grams

  2. Number of infants with low birthweight [ Time Frame: Delivery ]
    < 2500 grams, livebirth

  3. Gestational age (GA) [ Time Frame: Delivery ]
    GA at delivery in weeks/days, livebirth

  4. Preterm [ Time Frame: Delivery ]
    < 37 0/7 weeks, livebirth

  5. Number of infants that are small for gestational age [ Time Frame: Delivery ]
    Weight for gestational age < 10th percentile, livebirth

  6. Number of adverse newborn outcomes [ Time Frame: Delivery ]
    low birthweight OR preterm OR small for gestational age

  7. Number of spontaneous abortions [ Time Frame: Delivery ]
    Pregnancy loss < 22 0/7 weeks gestation

  8. Number of stillbirths [ Time Frame: Delivery ]
    Pregnancy loss ≥ 22 0/7 weeks gestation

  9. Number of early fetal deaths [ Time Frame: Delivery ]
    Pregnancy loss 22 0/7 - 27 6/7 weeks gestation

  10. Number of late fetal deaths [ Time Frame: Delivery ]
    Pregnancy loss ≥ 28 0/7 weeks gestation

  11. Number of pregnancy losses [ Time Frame: Delivery ]
    Spontaneous abortion OR stillbirth

  12. Number of neonatal deaths [ Time Frame: Delivery to 28 days Post-delivery ]
    Before the 28th day of life, livebirth

  13. Number of perinatal deaths [ Time Frame: Delivery to 28 days Post-delivery ]
    Late fetal death OR Neonatal death

  14. Incidence of clinical malaria during pregnancy [ Time Frame: Enrollment to Delivery (including each antenatal care visit) ]
    Maternal symptoms with peripheral malaria parasitemia detected by light microscopy or rapid diagnostic test

  15. Number of mothers with peripheral parasitemia at delivery [ Time Frame: Delivery ]
    Maternal peripheral parasitemia at delivery by PCR

  16. Mean maternal hemoglobin concentration [ Time Frame: Enrollment and Delivery ]
    Maternal hemoglobin (g/dL)

  17. Number of mothers with anemia at delivery [ Time Frame: Delivery ]
    Maternal Hb concentration ≤ 11 g/dL

  18. Number of mothers with severe anemia at delivery [ Time Frame: Delivery ]
    Maternal Hb concentration ≤ 7 g/dL


Other Outcome Measures:
  1. Number of maternal serious adverse events [ Time Frame: Enrollment to 28 days Post-delivery ]
    Serious adverse events in the mothers

  2. Number of infants with congenital malformations [ Time Frame: Delivery to 28 days Post-delivery ]
    Congenital malformations identified within the first 28 days of birth

  3. Number of offspring with the need for hospitalization or acute medical evaluation [ Time Frame: Delivery to 28 days Post-delivery ]
    Hospitalization or acute medical evaluation within the first 28 days of life


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757167


Contacts
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Contact: Stephen James, MPH 919-668-0420 stephen.james@duke.edu
Contact: Irene Okumu 919-660-6321 irene.okumu@duke.edu

Locations
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Congo, The Democratic Republic of the
Kinshasa School of Public Health Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Antoinette Tshefu, MD, PhD, MPH    +243998551185    antotshe@yahoo.com   
Contact: Jean Okitawutshu, MD       jeanokitawutshu@gmail.com   
Principal Investigator: Antoinette Tshefu, MD, PhD, MPH         
Kenya
Moi University Recruiting
Eldoret, Kenya
Contact: Jeremiah Laktabai, MBChB, MMED    +254532033235    jklaktabai@gmail.com   
Contact: Joseph Kipkoech    +254720393547    josepheddykipkoech@gmail.com   
Principal Investigator: Jeremiah Laktabai, MBChB, MMED         
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Steve M Taylor, MD, MPH Duke University
More Information
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Additional Information:

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05757167    
Other Study ID Numbers: Pro00110771
1U01AI162463-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Premature Birth
Stillbirth
Birth Weight
Protozoan Infections
Parasitic Diseases
Infections
Mosquito-Borne Diseases
Vector Borne Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Fetal Death
Death
Pathologic Processes
Body Weight
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents