Drug Resistant MalariaNCT03648411
Drug Resistance Among Asymptomatic Infection
An observational study of Drug Resistant Malaria and Asymptomatic Infections, run by Department of Medical Research, Lower Myanmar at 1 site in Burma.
Trial summary
A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Resistant Malaria, Asymptomatic Infections, Migrant Workers
- What is being tested?
- Drug resistance molecular markers
- How many people
- 765 participants
- Where
- 1 siteBurma
- Study dates
- 12 Jan 2019to 20 May 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The activity will cover the migrant population of the Shwegyin Township (Bago Region) and Pinlebu Township (Sagaing Region).
Who may be able to join
- Age above 6 year
- Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
- Both sex
- Participant who give informed-consent to participate the study
Who cannot join
- Known clinical malaria cases regardless of the species detected
- Patients with clinical symptoms of malaria at the time of examination
- Known history of malaria within 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar
A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.
Read the detailed description
Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.
In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.
- Being tested
- Drug resistance molecular markers
- Keywords
- malaria, falciparum, vivax, Myanmar, migrant workers, asymptomatic infection, drug resistance
- Medical subject headings
- Asymptomatic Infections, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug resistance molecular markersGenetic
Proportion of the drug resistance molecular markers will be found-out and compared.
| Study group | Role | What they receive |
|---|---|---|
| Shwegyin | Shwehyin is a Township in Bago Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared. Receives: Genetic: Drug resistance molecular markers | |
| Pinlebu | Pinlebu is a township in Sagaing Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared. Receives: Genetic: Drug resistance molecular markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the asymptomatic infection among the study population
Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)
Measured: 1 week
Proportion of the drug resistance molecular markers among asymptomatic infections
Among the asymptomatic cases, molecular markers will be analyzed (K13 and pfmdr1 copy number for falciparum and pvcrt-o, pvmdr1, pvdhps and pvdhfr gene analysis for vivax cases by Sanger Sequencing.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start12 Jan 2019
- Primary completion30 Dec 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant MalariaStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Research, Lower Myanmar
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Program, Myanmar
- Responsible party
- Principal investigator, Myat Htut Nyunt, Department of Medical Research, Lower Myanmar
- Investigators
- Myat H Nyunt, PhD, Principal investigator, Department of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648411
- Sponsor's protocol ID
- DMR_2018-108
- Status last verified
- Jul 2020
- First submitted
- 23 Aug 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar
- ClinicalTrials.gov ID
- NCT03648411
- Acronym / sponsor ID
- DMR_2018-108
- Keywords
- malaria, falciparum, vivax, Myanmar, migrant workers, asymptomatic infection, drug resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Department of Medical Research, Lower MyanmarUniversity, hospital or other
- Collaborators
- National Malaria Control Program, Myanmar
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 27 Aug 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.
A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.
Detailed description
Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.
In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shwegyin | – | Genetic: Drug resistance molecular markersShwehyin is a Township in Bago Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared. |
| Pinlebu | – | Genetic: Drug resistance molecular markersPinlebu is a township in Sagaing Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The activity will cover the migrant population of the Shwegyin Township (Bago Region) and Pinlebu Township (Sagaing Region).
Key inclusion criteria (4 listed)
- Age above 6 year
- Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
- Both sex
- Participant who give informed-consent to participate the study
Key exclusion criteria (3 listed)
- Known clinical malaria cases regardless of the species detected
- Patients with clinical symptoms of malaria at the time of examination
- Known history of malaria within 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug resistance molecular markersProportion of the drug resistance molecular markers will be found-out and compared. | Genetic | Pinlebu, Shwegyin |
Primary outcome
Prevalence of the asymptomatic infection among the study population
Time frame: 1 week
Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)
Proportion of the drug resistance molecular markers among asymptomatic infections
Time frame: 3 months
Among the asymptomatic cases, molecular markers will be analyzed (K13 and pfmdr1 copy number for falciparum and pvcrt-o, pvmdr1, pvdhps and pvdhfr gene analysis for vivax cases by Sanger Sequencing.
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 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Myat H Nyunt, PhD principal investigator
Department of Medical Research
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 Drug Resistant Malaria and Asymptomatic Infections, run by Department of Medical Research, Lower Myanmar 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 4 inclusion and 3 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 22 Jul 2020. 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?
Prevalence of the asymptomatic infection among the study population (time frame: 1 week). 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 22 Jul 2020.