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Dynamics of Subclinical Malaria: Preliminary Study

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ClinicalTrials.gov Identifier: NCT03483571
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Department of Medical Research, Myanmar Ministry of Health
International Centre for Diarrhoeal Disease Research, Bangladesh
National Institute of Parasitic Diseases, China CDC
Defence Services Medical Research Center, Myanmar
Information provided by (Responsible Party):
Duke University

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

Condition or disease
Malaria

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

Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Evaluation of Dynamics of Subclinical Malaria
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. Proportion of individuals with initially positive usPCR tests that were followed by 1 or more consecutive positive tests on weekly or biweekly testing [ Time Frame: 12 weeks ]
  2. Proportion of individuals with initially negative usPCR tests that subsequently had at least one usPCR positive test at a second screening 4 weeks later [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Incidence of falciparum malaria infection by RDT [ Time Frame: 2 years ]
  2. Incidence of vivax malaria infection by RDT [ Time Frame: 2 years ]
  3. Incidence of mixed falciparum/vivax malaria infection by RDT [ Time Frame: 2 years ]
  4. Incidence of falciparum malaria infection by usPCR [ Time Frame: 2 years ]
  5. Incidence of vivax malaria infection by usPCR [ Time Frame: 2 years ]
  6. Incidence of mixed falciparum/vivax malaria infection by usPCR [ Time Frame: 2 years ]
  7. Seroreactivity to polymorphic malaria/mosquito proteins [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
dry blood spot collected on filter papers and venous blood frozen


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483571


Contacts
Contact: Myaing M Nyunt, MD, PhD 9196138058 myaing.nyunt@duke.edu
Contact: Aung P Poe, MBBS, MPH +959261154819 poepaung@gmail.com

Sponsors and Collaborators
Duke University
Department of Medical Research, Myanmar Ministry of Health
International Centre for Diarrhoeal Disease Research, Bangladesh
National Institute of Parasitic Diseases, China CDC
Defence Services Medical Research Center, Myanmar
Investigators
Principal Investigator: Christopher V Plowe, MD, MPH Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] February 12, 2018


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03483571     History of Changes
Other Study ID Numbers: Pro00091895
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: PID will not be shared with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
asymptomatic
submicroscopic
PCR

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases