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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

Tracking Information
First Submitted Date  ICMJE February 24, 2023
First Posted Date  ICMJE March 7, 2023
Last Update Posted Date January 24, 2024
Actual Study Start Date  ICMJE November 6, 2023
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2023)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2023)
  • Birthweight [ Time Frame: Delivery ]
    Birthweight in grams
  • Number of infants with low birthweight [ Time Frame: Delivery ]
    < 2500 grams, livebirth
  • Gestational age (GA) [ Time Frame: Delivery ]
    GA at delivery in weeks/days, livebirth
  • Preterm [ Time Frame: Delivery ]
    < 37 0/7 weeks, livebirth
  • Number of infants that are small for gestational age [ Time Frame: Delivery ]
    Weight for gestational age < 10th percentile, livebirth
  • Number of adverse newborn outcomes [ Time Frame: Delivery ]
    low birthweight OR preterm OR small for gestational age
  • Number of spontaneous abortions [ Time Frame: Delivery ]
    Pregnancy loss < 22 0/7 weeks gestation
  • Number of stillbirths [ Time Frame: Delivery ]
    Pregnancy loss ≥ 22 0/7 weeks gestation
  • Number of early fetal deaths [ Time Frame: Delivery ]
    Pregnancy loss 22 0/7 - 27 6/7 weeks gestation
  • Number of late fetal deaths [ Time Frame: Delivery ]
    Pregnancy loss ≥ 28 0/7 weeks gestation
  • Number of pregnancy losses [ Time Frame: Delivery ]
    Spontaneous abortion OR stillbirth
  • Number of neonatal deaths [ Time Frame: Delivery to 28 days Post-delivery ]
    Before the 28th day of life, livebirth
  • Number of perinatal deaths [ Time Frame: Delivery to 28 days Post-delivery ]
    Late fetal death OR Neonatal death
  • 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
  • Number of mothers with peripheral parasitemia at delivery [ Time Frame: Delivery ]
    Maternal peripheral parasitemia at delivery by PCR
  • Mean maternal hemoglobin concentration [ Time Frame: Enrollment and Delivery ]
    Maternal hemoglobin (g/dL)
  • Number of mothers with anemia at delivery [ Time Frame: Delivery ]
    Maternal Hb concentration ≤ 11 g/dL
  • Number of mothers with severe anemia at delivery [ Time Frame: Delivery ]
    Maternal Hb concentration ≤ 7 g/dL
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2023)
  • Number of maternal serious adverse events [ Time Frame: Enrollment to 28 days Post-delivery ]
    Serious adverse events in the mothers
  • Number of infants with congenital malformations [ Time Frame: Delivery to 28 days Post-delivery ]
    Congenital malformations identified within the first 28 days of birth
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Official Title  ICMJE Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Malaria,Falciparum
  • Malaria in Pregnancy
  • Malaria in Childbirth
  • Pregnancy
  • Neonatal Health
  • Low Birthweight
  • Stillbirth
  • Gestational Age and Weight Conditions
  • Preterm Birth
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: HS-RDT screening/AL treatment
    Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
    Interventions:
    • Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)
    • Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet
  • No Intervention: Usual antenatal care
    Pregnant women will receive usual antenatal care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2023)		 2500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen James, MPH 919-668-0420 stephen.james@duke.edu
Contact: Irene Okumu 919-660-6321 irene.okumu@duke.edu
Listed Location Countries  ICMJE Congo, The Democratic Republic of the,   Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05757167
Other Study ID Numbers  ICMJE Pro00110771
1U01AI162463-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Steve M Taylor, MD, MPH Duke University
PRS Account Duke University
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP