Day-3 Positive of ParasitaemiaNCT02198573
Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar
An observational study of Day-3 Positive of Parasitaemia and Prevalence of Drug Resistance Gene Mutation, run by Myat Htut Nyunt at 1 site in Burma.
Trial summary
Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010. It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar. So, day-3 surveillance study have been conducted. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Day-3 Positive of Parasitaemia, Prevalence of Drug Resistance Gene Mutation
- How many people
- 91 participants
- Where
- 1 siteBurma
- Study dates
- Jul 2013to Jun 2014
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All of the malaria suspected cases were invited to participated in this study from Myanmar-Thailand border and Myanmar-Bangladesh border.
Who may be able to join
- confirmed uncomplicated falciparum malaria patients.
- age >2 years
- box sex
- given informed consent
Who cannot join
- severe malaria
- did not give informed consent
- others diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Assessment of Artemisinin Resistance Markers, K13 Kelch Propeller and Multi-drug Resistant Gene Polymorphism in Eastern and Western Border Areas of Myanmar
- Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010.
- It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar.
- So, day-3 surveillance study have been conducted.
- Recently artemisinin resistant molecular marker, K13 have been identified and it was used as a tool in this study.
- Keywords
- malaria, K13, pfmrp1, Myanmar
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
day-3 parasite positivity
All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.
Measured: 3 days
Secondary outcomes (1)
Prevalence of the drug resistance marker
By using the dried blood spots, drug resistance markers were detected by molecular method.
Measured: up to day-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Day-3 Positive of ParasitaemiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myat Htut Nyunt
- Sponsor type
- University, hospital or other
- Collaborators
- Kangwon National University
- Responsible party
- Sponsor-investigator, Myat Htut Nyunt, Department of Medical Research, Lower Myanmar
- Investigators
- Myat P Kyaw, PhD, Study director, Department of Medical Research, Lower Myanmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198573
- Sponsor's protocol ID
- WHO_3DF_2013_day3
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
Stepniewska K, Ashley E, Lee SJ, Anstey N, Barnes KI, Binh TQ, D'Alessandro U, Day NP, de Vries PJ, Dorsey G, Guthmann JP, Mayxay M, Newton PN, Olliaro P, Osorio L, Price RN, Rowland M, Smithuis F, Taylor WR, Nosten F, White NJ. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis. 2010 Feb 15;201(4):570-9. doi: 10.1086/650301.
PubMed 20085495Ariey F, Witkowski B, Amaratunga C, Beghain J, Langlois AC, Khim N, Kim S, Duru V, Bouchier C, Ma L, Lim P, Leang R, Duong S, Sreng S, Suon S, Chuor CM, Bout DM, Menard S, Rogers WO, Genton B, Fandeur T, Miotto O, Ringwald P, Le Bras J, Berry A, Barale JC, Fairhurst RM, Benoit-Vical F, Mercereau-Puijalon O, Menard D. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria. Nature. 2014 Jan 2;505(7481):50-5. doi: 10.1038/nature12876. Epub 2013 Dec 18.
PubMed 24352242Singh B, Bobogare A, Cox-Singh J, Snounou G, Abdullah MS, Rahman HA. A genus- and species-specific nested polymerase chain reaction malaria detection assay for epidemiologic studies. Am J Trop Med Hyg. 1999 Apr;60(4):687-92. doi: 10.4269/ajtmh.1999.60.687.
PubMed 10348249Kyaw MP, Nyunt MH, Chit K, Aye MM, Aye KH, Aye MM, Lindegardh N, Tarning J, Imwong M, Jacob CG, Rasmussen C, Perin J, Ringwald P, Nyunt MM. Reduced susceptibility of Plasmodium falciparum to artesunate in southern Myanmar. PLoS One. 2013;8(3):e57689. doi: 10.1371/journal.pone.0057689. Epub 2013 Mar 8.
PubMed 23520478
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Assessment of Artemisinin Resistance Markers, K13 Kelch Propeller and Multi-drug Resistant Gene Polymorphism in Eastern and Western Border Areas of Myanmar
- ClinicalTrials.gov ID
- NCT02198573
- Acronym / sponsor ID
- WHO_3DF_2013_day3
- Keywords
- malaria, K13, pfmrp1, Myanmar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Myat Htut NyuntUniversity, hospital or other
- Collaborators
- Kangwon National University
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Jul 2014 (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.
- Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010.
- It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar.
- So, day-3 surveillance study have been conducted.
- Recently artemisinin resistant molecular marker, K13 have been identified and it was used as a tool in this study.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All of the malaria suspected cases were invited to participated in this study from Myanmar-Thailand border and Myanmar-Bangladesh border.
Key inclusion criteria (4 listed)
- confirmed uncomplicated falciparum malaria patients.
- age >2 years
- box sex
- given informed consent
Key exclusion criteria (3 listed)
- severe malaria
- did not give informed consent
- others diseases
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
day-3 parasite positivity
Time frame: 3 days
All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.
1 secondary outcome
Prevalence of the drug resistance marker
Time frame: up to day-3
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 23 Jul 2014.
- BackgroundWorld Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
- BackgroundWorld Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
- Background: PubMed 20085495Stepniewska K, Ashley E, Lee SJ, Anstey N, Barnes KI, Binh TQ, D'Alessandro U, Day NP, de Vries PJ, Dorsey G, Guthmann JP, Mayxay M, Newton PN, Olliaro P, Osorio L, Price RN, Rowland M, Smithuis F, Taylor WR, Nosten F, White NJ. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis. 2010 Feb 15;201(4):570-9. doi: 10.1086/650301.
- Background: PubMed 24352242Ariey F, Witkowski B, Amaratunga C, Beghain J, Langlois AC, Khim N, Kim S, Duru V, Bouchier C, Ma L, Lim P, Leang R, Duong S, Sreng S, Suon S, Chuor CM, Bout DM, Menard S, Rogers WO, Genton B, Fandeur T, Miotto O, Ringwald P, Le Bras J, Berry A, Barale JC, Fairhurst RM, Benoit-Vical F, Mercereau-Puijalon O, Menard D. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria. Nature. 2014 Jan 2;505(7481):50-5. doi: 10.1038/nature12876. Epub 2013 Dec 18.
- Background: PubMed 10348249Singh B, Bobogare A, Cox-Singh J, Snounou G, Abdullah MS, Rahman HA. A genus- and species-specific nested polymerase chain reaction malaria detection assay for epidemiologic studies. Am J Trop Med Hyg. 1999 Apr;60(4):687-92. doi: 10.4269/ajtmh.1999.60.687.
- Results publication: PubMed 23520478Kyaw MP, Nyunt MH, Chit K, Aye MM, Aye KH, Aye MM, Lindegardh N, Tarning J, Imwong M, Jacob CG, Rasmussen C, Perin J, Ringwald P, Nyunt MM. Reduced susceptibility of Plasmodium falciparum to artesunate in southern Myanmar. PLoS One. 2013;8(3):e57689. doi: 10.1371/journal.pone.0057689. Epub 2013 Mar 8.
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 P Kyaw, PhD study director
Department of Medical Research, Lower Myanmar
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 Day-3 Positive of Parasitaemia and Prevalence of Drug Resistance Gene Mutation, run by Myat Htut Nyunt 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 23 Jul 2014. 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?
day-3 parasite positivity (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02198573, which also lists 6 linked publications.
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 23 Jul 2014.