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Molecular Testing
LAMP Testing for Malaria in Pregnancy (LAMPREG Trial)
N/A
Recruiting
Led By Dylan Pillai, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery and post hoc
Awards & highlights
LAMPREG Trial Summary
This trial will test whether using a molecular test to detect malaria cases can reduce maternal and infant morbidity and mortality.
Who is the study for?
The LAMPREG trial is for pregnant women in Ethiopia who are in their first or early second trimester. They must consent to participate and not have a high-risk pregnancy, severe malaria, multiple previous births (multiparity), undatable pregnancy, or be in the third trimester.Check my eligibility
What is being tested?
This study compares standard malaria detection by microscopy with an enhanced method using LAMP testing on maternal and infant health outcomes. Pregnant women will either receive usual care or additional LAMP tests regardless of symptoms and treated if positive.See study design
What are the potential side effects?
There may not be direct side effects from the diagnostic interventions themselves; however, treatments following a positive test result could include quinine or ACTs which can have side effects like nausea, dizziness, or allergic reactions.
LAMPREG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Obstetric Delivery
Secondary outcome measures
Absolute birth weight
Maternal hemoglobin
Neonatal hemoglobin at birth
+2 moreOther outcome measures
Assessment of the development of placental malaria
Performance of diagnosis methods compared to qRT-PCR as a gold standard
LAMPREG Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment2 Interventions
The remaining two-thirds of participants will be actively screened (symptomatic and asymptomatic) for Plasmodium infection at each antenatal visit, using both LAMP and conventional techniques (microscopy and RDT). If either is positive, participants will be treated with antimalarial therapy according to Ethiopian Ministry of Health guidelines. If both are negative then they receive no treatment.
Group II: Standard of careActive Control1 Intervention
One third of individuals get allocated to the standard of care arm. At each antenatal visit as per Ethiopian guidelines, pregnant women enrolled in the study will be submitted to the standard of care for malaria in pregnancy. If the pregnant mothers are symptomatic for malaria, they receive microscopy (blood smear for Plasmodium detection) and then are treated with anti-malarial therapy if microscopy is positive for Plasmodium. If it is negative they receive no treatment. If they are asymptomatic, they do not receive any further investigations or treatment in relation to malaria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LAMP
2020
N/A
~30
Find a Location
Who is running the clinical trial?
Armauer Hansen Research Institute, EthiopiaOTHER
22 Previous Clinical Trials
87,543 Total Patients Enrolled
2 Trials studying Malaria
48,960 Patients Enrolled for Malaria
Amhara Public Health Institute, EthiopiaUNKNOWN
University of CalgaryLead Sponsor
792 Previous Clinical Trials
866,571 Total Patients Enrolled
1 Trials studying Malaria
4,071 Patients Enrolled for Malaria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had multiple pregnancies.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care
- Group 2: Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join this clinical experiment at the moment?
"As per information posted on clinicaltrials.gov, this research endeavour is actively seeking participants. The trial was initially made public on June 18th 2021 and the latest alteration to its listing occurred on June 24th 2022."
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