Dynamics of Subclinical Malaria: Preliminary Study

NCT ID: NCT03483571

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2970 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2019-09-03

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

Detailed Description

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. In this study, a small number of asymptomatic infections detected by ultrasensitive PCR (usPCR) will be followed and tested intensively for three months to measure the temporal dynamics of these infections. A much larger number of uninfected individuals will be followed for just 2-4 weeks (two visits), providing a comparator group for the infected cohort. The validity of our results in a subsequent matched cohort study depends, in part, on our ability to accurately classify infection status using a single usPCR result. In other words, do the investigators have sufficient confidence in the correct classification of malaria infection positive and negative status using usPCR test at the beginning of the study? While there is no gold standard test more sensitive than usPCR, repeated usPCR testing offers a surrogate. Presumably, in a low transmission setting, someone who is truly uninfected on the first testing should remain negative on multiple consecutive tests, but this remains to be confirmed.

The investigators will enroll study participants in up to six study sites, each with >2 villages, towns, unions, refugee camps or plantations, or a single military base. Alternative and additional sites may be added to ensure enough infected cases. The investigators will screen for eligibility (age at least 0.5 year; able & willing to strictly follow study protocol and to provide written informed consent or assent as appropriate) and enroll and consent eligible individuals. Study procedures are based on test results:

• RDT-positive: one-time enrollment for data and venous blood collection; Refer to and ensure appropriate treatment by care providing team; No study-related follow up
• RDT-negative: Collect data and DBS samples; Return to research clinic in 2-4 weeks
• PCR-negative participants: One follow up visit approximately 2-4 weeks after enrollment
• PCR-positive participants: Five follow up visits at approximately 4, 6, 8, 10, and 12 weeks (for those with total 12 weeks follow up) or 2, 3, 4, 5 and 6 weeks (for those with total 6 weeks follow up) after enrollment
• Finger stick blood sampling with be done for RDT and dried blood spot sampling in all participants at each scheduled and unscheduled visit.
• Venous sampling will be done for participants with RDT+ infections detected at times when study staff trained for venous sampling are present. Blood volumes at any time point are limited to 2 mL for children aged < 3 years, 3 mL for age 3-5 years, and 5 mL for older children and adults.
• Estimated duration of study:18 months

Conditions

Malaria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health and Sports, Myanmar

OTHER_GOV

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

National Institute of Parasitic Diseases, China CDC

UNKNOWN

Sponsor Role: collaborator

Defence Services Medical Research Center, Myanmar

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher V Plowe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Department of Medical Research

Yangon, , Burma

Countries

Burma

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00091895

Identifier Type: -

Identifier Source: org_study_id