Dynamics of Subclinical Malaria: Preliminary Study

NCT03483571 | Completed

• 1 other identifier: Pro00091895
• Study Type: observational
• Target: 2,970
• Locations: 1 country
• Sites: 1

Brief Summary

This is a short longitudinal preliminary study that aims to describe the dynamics of low-density subclinical malaria to support the final study design of a subsequent matched cohort study. The primary objective is to assess the dynamics of subclinical malaria detected by ultrasensitive PCR over a short duration. The results will be used to guide the design of a matched cohort study of subclinical malaria in Myanmar and along its borders with China and Bangladesh

Conditions

Malaria

Keywords

asymptomatic; submicroscopic; PCR

Outcome Measures

Primary Outcomes (2)

• Proportion of individuals with initially positive usPCR tests that were followed by 1 or more consecutive positive tests on weekly or biweekly testing

  Proportion of individuals with initially positive usPCR

  12 weeks

• Proportion of individuals with initially negative usPCR tests that subsequently had at least one usPCR positive test at a second screening 4 weeks later

  Proportion of individuals with initially negative usPCR tests

  4 weeks

Secondary Outcomes (7)

• Incidence of falciparum malaria infection by RDT

  2 years

• Incidence of vivax malaria infection by RDT

  2 years

• Incidence of mixed falciparum/vivax malaria infection by RDT

  2 years

• Incidence of falciparum malaria infection by usPCR

  2 years

• Incidence of vivax malaria infection by usPCR

  2 years

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sites broadly representative of the range of malaria epidemiologies seen in the region have been identified based on available data on the incidence of clinical malaria and prevalence of subclinical malaria (measured by both standard testing and by usPCR in surveys we have supported). In a staged fashion, initial screening will be undertaken at these sites, starting with the sites in Myanmar, where laboratories proficient in usPCR have been established.

You may qualify if:

• Age 6 months or older at the time of screening; Written informed consent obtained (from the parent/guardian if the subject is less than 18 years old).

You may not qualify if:

• Any condition which in the view of the investigator makes participation not in the best interests of the prospective participant. Any condition that would interfere with study participation or pose risks to participants. Those with clinical malaria infection as diagnosed by positive RDT may be invited to return and be re-screened for study eligibility after treatment and resolution of their illness.

Sponsors & Collaborators

• Duke University: lead
• Ministry of Health and Sports, Myanmar: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• National Institute of Parasitic Diseases, China CDC: collaborator
• Defence Services Medical Research Center, Myanmar: collaborator

Study Sites (1)

Department of Medical Research

Yangon, Burma

Location

Biospecimen

Retention: SAMPLES WITH DNA

dry blood spot collected on filter papers and venous blood frozen

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Christopher V Plowe, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 30, 2018
• Study Start: July 26, 2018
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)