NCT03172221

Brief Summary

This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs \[loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)\], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

May 29, 2017

Last Update Submit

November 29, 2023

Conditions

Plasmodium FalciparumPregnancy MalariaDiagnoses Disease

Keywords

malariapregnancydiagnosislow-transmissionPlasmodium falciparumrapid diagnostic test

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.

    1 year

Interventions

HS-RDTDIAGNOSTIC_TEST

A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.

Also known as: ultrasensitive RDT

Eligibility Criteria

Age15 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will include pregnant women
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive pregnant women self-presenting at the selected health care facilities and meeting the eligibility criteria will be invited to participate in the study. After study staff provides full information about the study, pregnant women willing to participate will be asked to sign the informed consent form. They will consent to be interviewed and to provide finger-prick blood. For women younger than 18 years old, additional approval from the parent or legal guardian will be needed if required by local Institutional Review Board (IRB). Participants will be invited to participate at any visit at any trimester.

You may qualify if:

  • Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
  • Resident for at least 1 year in the study site
  • Age ≥ 15
  • Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age \< 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
  • Willingness to provide finger-prick blood sample at enrolment

You may not qualify if:

  • Past history of malaria and/or antimalarial drugs in the last three months
  • Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
  • Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
  • Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Salud el Reposo

Quibdó, Colombia

Location

Hospital Divino Nino

Tumaco, Colombia

Location

Related Publications (1)

  • Vasquez AM, Velez G, Medina A, Serra-Casas E, Campillo A, Gonzalez IJ, Murphy SC, Seilie AM, Ding XC, Tobon Castano A. Evaluation of highly sensitive diagnostic tools for the detection of P. falciparum in pregnant women attending antenatal care visits in Colombia. BMC Pregnancy Childbirth. 2020 Jul 31;20(1):440. doi: 10.1186/s12884-020-03114-4.

    PMID: 32736543DERIVED

MeSH Terms

Conditions

Malaria, FalciparumMalariaDisease

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

July 25, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)