LAMP Detection of Malaria in PREGnancy (LAMPREG) Trial

NCT03754322 | Completed

• 1 other identifier: REB17-1335
• Study Type: interventional
• Target: 2,424
• Locations: 2 countries
• Sites: 4

Brief Summary

Objective: The aim of this study is to evaluate the impact of enhanced malaria cases detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design. A pragmatic randomized control diagnostic trial will be conducted from October 2020 until March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic first and early second trimester pregnant women will be included in the study and individually randomized to either standard of care or enhanced cased detection arms using LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing the peak transmission seasons and then followed until delivery. In the standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm, mothers who are symptomatic or asymptomatic will be tested by a commercially available CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated if positive by any test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcome is the proportion of deliveries with low birth weight based on WHO definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and (vi) prematurity in each arm of the study.

Conditions

Malaria; Pregnancy Malaria; Malaria in Pregnancy

Keywords

Plasmodium; Pregnancy; Malaria; LAMP; Asymptomatic infections; Low Birth Weight; Outcomes

Outcome Measures

Primary Outcomes (1)

• Proportion of deliveries with low birth weight

  Birth weight will be considered as low if \< 2500 g

  At the head to toe assessment of the baby within 24 hours of delivery

Secondary Outcomes (5)

• Absolute birth weight

  At the head to toe assessment of the baby within 24 hours of delivery

• Maternal hemoglobin

  During the pregnancy and at delivery

• Neonatal hemoglobin at birth

  At the head to toe assessment of the baby within 24 hours of delivery

• Proportion of fetal loss

  During the study time, for each inclusion until delivery

• Prematurity

  At delivery

Other Outcomes (2)

• Performance of diagnosis methods compared to qRT-PCR as a gold standard

  At the end of the study

• Assessment of the development of placental malaria

  At delivery and post hoc

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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.

Diagnostic Test: Microscopy/RDT

Intervention arm

EXPERIMENTAL

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.

Diagnostic Test: LAMP; Diagnostic Test: Microscopy/RDT

Interventions

LAMP DIAGNOSTIC_TEST

LAMP testing involves taking a blood specimen using venous puncture, extracting DNA and performing a commercial CE-marked LAMP malaria assay to obtain a malaria result (presence/absence of parasite DNA) at the species level

Intervention arm

Microscopy/RDT DIAGNOSTIC_TEST

Standard of care management of malaria in pregnancy relies on microscopy and/or RDT for diagnosis

Intervention arm; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a pregnant woman in the first or second trimester at time of enrollment
• Consent to the study

You may not qualify if:

• Pregnant woman in the third trimester at time of enrollment
• Multiparity
• At risk pregnancy as per Ethiopian guidelines
• Impossibility to date pregnancy

Sponsors & Collaborators

• University of Calgary: lead
• Jimma University: collaborator
• Amhara Public Health Institute, Ethiopia: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator

Study Sites (4)

University of Calgary

Calgary, Alberta, T2L 2K8, Canada

Location

Amhara Public Health Institute

Bahir Dar, Amhara, Ethiopia

Location

Tropical & Infectious Diseases Research Center (TIDRC), Jimma University

Jimma, Oromiya, Ethiopia

Location

Armauer Hansen Research Institute, Ethiopia

Addis Ababa, Ethiopia

Location

Related Publications (1)

• Gebresenbet RF, Kamaliddin C, Bekele ZM, Teferi M, Tegegne B, Yewhalaw D, Bayih AG, Pillai DR; LAMPREG Study Group. Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial-study protocol. BMJ Open. 2022 Jul 18;12(7):e058397. doi: 10.1136/bmjopen-2021-058397.

  PMID: 35851027 DERIVED

MeSH Terms

Conditions

Malaria; Asymptomatic Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dylan Pillai, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: November 27, 2018
• Study Start: June 18, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ET (3); CA (1)