Serological Screen and Treat Trial for Plasmodium Vivax

NCT04223674 | Unknown DMC

• 1 other identifier: 19-09-1129
• Study Type: interventional
• Target: 1,133
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to evaluate the efficacy of serological screening vs. routine care for the prevention of recurrent P. vivax infections. A total of 960 schoolchildren will be randomized into the interventional or control arm.

Conditions

Malaria, Vivax

Keywords

serology; screen; treat; recurrent; vivax

Outcome Measures

Primary Outcomes (1)

• Incidence reduction

  Difference of P. vivax incidence by PCR between children serologically screened and those receiving routine care.

  9 month of follow up

Secondary Outcomes (10)

• Time-to recur

  9 month

• Recurrence number

  9 month

• Recurrent symptomatic P. vivax

  9 month

• Seroconversion rate

  9 month

• point-of-care assay performance

  one month

Study Arms (2)

Serological screen and treat

EXPERIMENTAL

Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided for those with Pv seropositive regardless of their symptoms and symptomatic children with microscopic Pv/Po positive.

Diagnostic Test: Serological screen and treat

Routine care

NO INTERVENTION

Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided only for symptomatic children with microscopic Pv/Po positive.

Interventions

Serological screen and treat DIAGNOSTIC_TEST

Multi-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment

Serological screen and treat

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• resident of study area and attending selected elementary school in Grade 1-5 or middle school Grade 1-3
• no evidence of health condition that would interfere with study participation
• assent of child and documented parental informed consent

You may not qualify if:

• G6PD deficiency as determined by SD Biosensor quantitative determination of \<70% G6PD activity (\<6 U/g Hb).
• Haemoglobin \< 9 g/dL

Sponsors & Collaborators

• Indonesia University: lead
• Eijkman Institute for Molecular Biology: collaborator
• Oxford University Clinical Research Unit Indonesia: collaborator
• Walter and Eliza Hall Institute of Medical Research: collaborator
• Rumah Sakit Umum Daerah Mimika: collaborator
• Universitas Sumatera Utara: collaborator

Study Sites (1)

Tanjung Tiram Primary Health Center

Tanjung Tiram, Batubara, 21253, Indonesia

Location

MeSH Terms

Conditions

Malaria, Vivax; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Inge Sutanto, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study evaluates an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. 960 children living in western Indonesia will be individually randomised to the experimental serologic test or routine care. Children in the serological diagnosis arm will be screened for the presence of antibodies to a previously validated panel of malaria antigens optimized for sensitivity to infection during the prior 9 months. Furthermore, they also will be screened by microscopy. If positive by either test, they will be treated for that malaria infection. Children assigned to routine care will be screened by microscopic examination and treated when they show or have history of symptoms in the last 3 days. After initial screening and treating according to diagnostic technique, all children will be actively followed for 9 months with PCR detection every 4 weeks.

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 10, 2020
• Study Start: February 9, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: No end date
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research

Locations

ID (1)