Drug ResistanceNCT02792816
Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar
An observational study of Drug Resistance and Plasmodium Falciparum Malaria, run by Department of Medical Research, Lower Myanmar at 1 site in Burma.
Trial summary
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis Read more about this study
- Who is it for?
- Ages 3 months to 69 years
- Conditions the study is for
- Drug Resistance, Plasmodium Falciparum Malaria
- What is being tested?
- First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
- How many people
- 550 participants
- Where
- 1 siteBurma
- Study dates
- Jun 2009to May 2016
- 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 3 months to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar
Who may be able to join
- Plasmodium falciparum mono infection by microscopy
- Presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours
- Ability to swallow oral medication
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
- Informed consent from the patient or from a parent or guardian in the case of children
Who cannot join
- Presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (WHO)
- Mixed or mono-infection with another Plasmodium species detected by microscopy
- Presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm)
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (AIDS)
- Regular medication, which may interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
- A positive pregnancy test or breastfeeding
- Unable to or unwilling to take a pregnancy test or contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis
Read the detailed description
The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).
- Conditions
- Drug Resistance, Plasmodium Falciparum Malaria
- Being tested
- First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)Drug
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
| Study group | Role | What they receive |
|---|---|---|
| Kawthaung Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Kawthaung is one of the sentinel site and located at the Southern Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | |
| Myawaddy Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Myawaddy is one of the sentinel site and located at the northern part of the Southern Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | |
| Thanbyuzayat Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Thanbyuzayat is one of the sentinel site and located at the northern part of the Southern Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | |
| Shwegyin Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Shwegyin is one of the sentinel site and located at the southern part of the central Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | |
| Magway Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Magway is one of the sentinel site and located at the middle part of the central Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | |
| Rakhine Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Rakhine is one of the sentinel site and located at the western Myanmar. Receives: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adequate clinical and parasitological response (ACPR)
For artesunate-mefloquine or dihydroartemisinin-piperaquine, 42 days follow-ups and for artemether-lumefrantrine combinations, 28 days followe-ups
Measured: day 28 or day 42 after initial dose of ACT
Secondary outcomes (3)
Proportion of the day-3 parasite positivity after ACT by microscopy
72 hr after ACT is one of the indicator for delayed clearance of parasitaemia in falciparum malaria
Measured: 3rd day after initial dose of ACT
Treatment failure rate
Early Treatment Failure (ETF), Late Clinical Failure (LCF), Late Parasitological Failure (LPF) based on the WHO standard protocol and definitions
Measured: anytime within observation period (28/42 days after treatment with one of ACTs)
Mutant rate
Day-0 samples were used to amplify the artemisinin resistance molecular markers to know the mutant rate in each study sites
Measured: Day-0 samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 550 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
- NCT02792816
- Sponsor's protocol ID
- KMRL_2016_02
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We may share the data on request after publication.
Publications
Nyunt MH, Soe MT, Myint HW, Oo HW, Aye MM, Han SS, Zaw NN, Cho C, Aung PZ, Kyaw KT, Aye TT, San NA, Ortega L, Thimasarn K, Bustos MDG, Galit S, Hoque MR, Ringwald P, Han ET, Kyaw MP. Clinical and molecular surveillance of artemisinin resistant falciparum malaria in Myanmar (2009-2013). Malar J. 2017 Aug 14;16(1):333. doi: 10.1186/s12936-017-1983-9.
PubMed 28806957
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
- ClinicalTrials.gov ID
- NCT02792816
- Acronym / sponsor ID
- KMRL_2016_02
- Conditions
- Drug Resistance, Plasmodium Falciparum Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Department of Medical Research, Lower MyanmarUniversity, hospital or other
- Collaborators
- Kangwon National University
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Jun 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.
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis
Detailed description
The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Kawthaung Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Kawthaung is one of the sentinel site and located at the Southern Myanmar. |
| Myawaddy Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Myawaddy is one of the sentinel site and located at the northern part of the Southern Myanmar. |
| Thanbyuzayat Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Thanbyuzayat is one of the sentinel site and located at the northern part of the Southern Myanmar. |
| Shwegyin Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Shwegyin is one of the sentinel site and located at the southern part of the central Myanmar. |
| Magway Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Magway is one of the sentinel site and located at the middle part of the central Myanmar. |
| Rakhine Site | – | Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Rakhine is one of the sentinel site and located at the western Myanmar. |
Who may qualify
- Ages
- 3 months to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar
Key inclusion criteria (5 listed)
- Plasmodium falciparum mono infection by microscopy
- Presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours
- Ability to swallow oral medication
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
- Informed consent from the patient or from a parent or guardian in the case of children
Key exclusion criteria (8 listed)
- Presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (WHO)
- Mixed or mono-infection with another Plasmodium species detected by microscopy
- Presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm)
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (AIDS)
- Regular medication, which may interfere with antimalarial pharmacokinetics
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 |
|---|---|---|
| First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety. | Drug | Kawthaung Site, Magway Site, Myawaddy Site, Rakhine Site, Shwegyin Site, Thanbyuzayat Site |
Primary outcome
Proportion of adequate clinical and parasitological response (ACPR)
Time frame: day 28 or day 42 after initial dose of ACT
For artesunate-mefloquine or dihydroartemisinin-piperaquine, 42 days follow-ups and for artemether-lumefrantrine combinations, 28 days followe-ups
3 secondary outcomes
Proportion of the day-3 parasite positivity after ACT by microscopy
Time frame: 3rd day after initial dose of ACT
Treatment failure rate
Time frame: anytime within observation period (28/42 days after treatment with one of ACTs)
Mutant rate
Time frame: Day-0 samples
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 8 Jun 2016.
- Derived from this study: PubMed 28806957Nyunt MH, Soe MT, Myint HW, Oo HW, Aye MM, Han SS, Zaw NN, Cho C, Aung PZ, Kyaw KT, Aye TT, San NA, Ortega L, Thimasarn K, Bustos MDG, Galit S, Hoque MR, Ringwald P, Han ET, Kyaw MP. Clinical and molecular surveillance of artemisinin resistant falciparum malaria in Myanmar (2009-2013). Malar J. 2017 Aug 14;16(1):333. doi: 10.1186/s12936-017-1983-9.
- Individual participant dataSharing planned: Undecided. We may share the data on request after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Resistance and Plasmodium Falciparum Malaria, 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 5 inclusion and 8 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 8 Jun 2016. 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 adequate clinical and parasitological response (ACPR) (time frame: day 28 or day 42 after initial dose of ACT). 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 NCT02792816, which also lists 1 linked publication.
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 8 Jun 2016.