MalariaNCT03483571
Dynamics of Subclinical Malaria: Preliminary Study
An observational study of Malaria, run by Duke University at 1 site in Burma.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 2,970 participants
- Where
- 1 siteBurma
- Study dates
- 26 Jul 2018to 3 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Evaluation of Dynamics of Subclinical Malaria
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
Read the 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
- Keywords
- asymptomatic, submicroscopic, PCR
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Secondary outcomes (7)
Incidence of falciparum malaria infection by RDT
Incidence of falciparum malaria infection by RDT
Measured: 2 years
Incidence of vivax malaria infection by RDT
Incidence of vivax malaria infection by RDT
Measured: 2 years
Incidence of mixed falciparum/vivax malaria infection by RDT
Incidence of mixed falciparum/vivax malaria infection by RDT
Measured: 2 years
Incidence of falciparum malaria infection by usPCR
Incidence of falciparum malaria infection by usPCR
Measured: 2 years
Incidence of vivax malaria infection by usPCR
Incidence of vivax malaria infection by usPCR
Measured: 2 years
Incidence of mixed falciparum/vivax malaria infection by usPCR
Incidence of mixed falciparum/vivax malaria infection by usPCR
Measured: 2 years
Seroreactivity to polymorphic malaria/mosquito proteins
Seroreactivity to polymorphic malaria/mosquito proteins
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start26 Jul 2018
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Sports, Myanmar, International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Parasitic Diseases, China CDC, Defence Services Medical Research Center, Myanmar
- Responsible party
- Sponsor
- Investigators
- Christopher V Plowe, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483571
- Sponsor's protocol ID
- Pro00091895
- Status last verified
- May 2021
- First submitted
- 15 Mar 2018
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PID will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of Dynamics of Subclinical Malaria
- ClinicalTrials.gov ID
- NCT03483571
- Acronym / sponsor ID
- Pro00091895
- Conditions
- Malaria
- Keywords
- asymptomatic, submicroscopic, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,970 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Sports, Myanmar, International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Parasitic Diseases, China CDC, Defence Services Medical Research Center, Myanmar
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Proportion of individuals with initially positive usPCR
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
Proportion of individuals with initially negative usPCR tests
7 secondary outcomes
Incidence of falciparum malaria infection by RDT
Time frame: 2 years
Incidence of vivax malaria infection by RDT
Time frame: 2 years
Incidence of mixed falciparum/vivax malaria infection by RDT
Time frame: 2 years
Incidence of falciparum malaria infection by usPCR
Time frame: 2 years
Incidence of vivax malaria infection by usPCR
Time frame: 2 years
Incidence of mixed falciparum/vivax malaria infection by usPCR
Time frame: 2 years
Seroreactivity to polymorphic malaria/mosquito proteins
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No. PID will not be shared with other researchers
Related trials for Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher V Plowe, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Duke University at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.