Increased Drug ResistanceNCT02708199
Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases and Malaria Antibody Kinetic
An observational study of Increased Drug Resistance and Asymptomatic Infection, run by Department of Medical Research, Lower Myanmar.
Trial summary
Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Increased Drug Resistance, Asymptomatic Infection, Malaria
- How many people
- 1,179 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Shwegyin Township, Bago Region, Myanmar Artemisinin resistance containment Zone I.
Who may be able to join
- Local resident in stud sites
- Who give informed consent
- No known tentative plan to move/ migrant elsewhere within one year
Who cannot join
- Migrant or mobile population
- Less than 6 year
About this study
Official title: Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases in Myanmar Artemisinin Resistance Containment Zones and Malaria Antibody Kinetic Analysis
Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I.
Read the detailed description
This study is longitudinal and observational cohort study to detect the drug resistance molecular markers in asymptomatic malaria infected local residents in study site. Only local residence who are not migrants, are recruited in the study and active and passive surveillance have been carried out within one year observation period. At the time of enrollment, blood film examination, rapid diagnosis test (RDT) testing have been done all together with the collection of the venous blood (about 1-2 mL) that would be used for molecular analysis later. All of the RDT or microscopy positive cases were treated according to the National Malaria Treatment Policy in Myanmar. A total of at least 1000 participants have been recruited in the study. Active case detection has been done in every three months. The venous blood were used for molecular based detection of the asymptomatic malaria infection by using High-throughout pooling strategy. All of the positive samples, (falciparum and vivax), have been checked for drug resistance molecular analaysis compared with the previously collected symptomatic malaria infection cases in the same region.
- Conditions
- Increased Drug Resistance, Asymptomatic Infection, Malaria
- Keywords
- Drug resistance malaria, Myanmar Artemisinin Resistance Containment Zone, Asymptomatic malaria, Serology
- Medical subject headings
- Asymptomatic Infections, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Asymptomatic malaria infection
Number of the asymptomatic malaria infection by molecular method in the sample collected from apparently healthy individuals. It have been done by nested PCR based method. Number of the asymptomatic infection will be finished in March 2016. (up to up to 5 months after last samples collection)
Measured: 2016 March
Secondary outcomes (2)
Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection
K13, Pffd, Pfmdr2 and Pfcrt markers for falciparum and Pvcrt-O, Pvdhps, Pvdhfr and Pvmdr1 for vivax asymptomatic infections.The target sequences will be analysed to detect the specific single nucleotide polymorphism (SNPs). Molecular marker analysis will be done as soon as after asymptomatic infection have been confirmed. It will be finished in 2016 April. (up to 6 months after last sample collection)
Measured: 2016 April
Prevalence of the different Malaria Antibody in local resident in Myanmar
Malaria antibody that against the malaria parasites will be assessed by using high sensitive protein microarray. Total overall prevalence will be assessed and time to time change of the antibody status will be observed. It will be started in April until December 2016.(Up to 14 months after last sample collection)
Measured: 2016 December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Drug ResistanceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Research, Lower Myanmar
- Sponsor type
- University, hospital or other
- Collaborators
- Kangwon National University
- Responsible party
- Principal investigator, Myat Htut Nyunt, Department of Medical Research, Lower Myanmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708199
- Sponsor's protocol ID
- KMRL_01_2016
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The data may be shared after publish.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases in Myanmar Artemisinin Resistance Containment Zones and Malaria Antibody Kinetic Analysis
- ClinicalTrials.gov ID
- NCT02708199
- Acronym / sponsor ID
- KMRL_01_2016
- Conditions
- Increased Drug Resistance, Asymptomatic Infection, Malaria
- Keywords
- Drug resistance malaria, Myanmar Artemisinin Resistance Containment Zone, Asymptomatic malaria, Serology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- Department of Medical Research, Lower MyanmarUniversity, hospital or other
- Collaborators
- Kangwon National University
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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.
Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I.
Detailed description
This study is longitudinal and observational cohort study to detect the drug resistance molecular markers in asymptomatic malaria infected local residents in study site. Only local residence who are not migrants, are recruited in the study and active and passive surveillance have been carried out within one year observation period. At the time of enrollment, blood film examination, rapid diagnosis test (RDT) testing have been done all together with the collection of the venous blood (about 1-2 mL) that would be used for molecular analysis later. All of the RDT or microscopy positive cases were treated according to the National Malaria Treatment Policy in Myanmar. A total of at least 1000 participants have been recruited in the study. Active case detection has been done in every three months. The venous blood were used for molecular based detection of the asymptomatic malaria infection by using High-throughout pooling strategy. All of the positive samples, (falciparum and vivax), have been checked for drug resistance molecular analaysis compared with the previously collected symptomatic malaria infection cases in the same region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Shwegyin Township, Bago Region, Myanmar Artemisinin resistance containment Zone I.
Key inclusion criteria (3 listed)
- Local resident in stud sites
- Who give informed consent
- No known tentative plan to move/ migrant elsewhere within one year
Key exclusion criteria (2 listed)
- Migrant or mobile population
- Less than 6 year
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
Number of the Asymptomatic malaria infection
Time frame: 2016 March
Number of the asymptomatic malaria infection by molecular method in the sample collected from apparently healthy individuals. It have been done by nested PCR based method. Number of the asymptomatic infection will be finished in March 2016. (up to up to 5 months after last samples collection)
2 secondary outcomes
Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection
Time frame: 2016 April
Prevalence of the different Malaria Antibody in local resident in Myanmar
Time frame: 2016 December
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 15 Mar 2016.
- Individual participant dataSharing planned: Undecided. The data may be shared after publish.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Increased Drug Resistance and Asymptomatic Infection, run by Department of Medical Research, Lower Myanmar.
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 3 inclusion and 2 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of the Asymptomatic malaria infection (time frame: 2016 March). 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 15 Mar 2016.