MalariaNCT03217851
Prevalence Survey of Antimalarial Drug Resistance Markers
An observational study of Malaria, run by University of Oxford at 1 site in Thailand.
Trial summary
Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Malaria
- What is being tested?
- Blood Collection and Dried Blood Spot
- How many people
- 4,000 participants
- Where
- 1 siteThailand
- Study dates
- 18 Sep 2017to 24 Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients age 6 months - 75 years presenting at study site with confirmed P. falciparum infection
Who may be able to join
- Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
- Written informed consent obtained (by parents/guardian in case of children less than 18 years old)
Who cannot join
- Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.
- Guideline for the treatment of Malaria-3rd edition, WHO (27) Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P.falciparum asexual parasitaemia.
- Impaired consciousness: A Glasgow comma score < 11 in adults or Blantyre coma score < 3 in children
- Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.
- Multiple convulsions: More than two episodes within 24 h
- Acidosis: A base deficit of > 8 mEq/L or, if not available a plasma bicarbonate level of < 15 mmol/L or venous plasma lactate ≥ 5 mmol/L. Severe acidosis manifests clinically as respiratory distress (rapid, deep, laboured breathing).
Show all 14Show fewer
- Hypoglycaemia: Blood or plasma glucose < 2.2 mmol/L (<40 mg/dL)
- Severe malarial anaemia: Haemoglobin concentration ≤ 5 g/dL or a haematocrit of ≤ 15% in children < 12 years of age (< 7 g/dL and < 20%, respectively, in adults) with a parasite count > 10,000/µL
- Renal impairment: Plasma or serum creatinine > 265 µmol/L (3 mg/dL) or blood urea > 20 mmol/L
- Jaundice: Plasma or serum bilirubin > 50 µmol/L (3 mg/dL) with a parasite count > 100,000/ µL
- Pulmonary oedema: Radiologically confirmed or oxygen saturation < 92% on room air with a respiratory rate > 30/min, often with chest indrawing and crepitations on auscultation
- Significant bleeding: Including recurrent or prolonged bleeding from the nose, gums or venepuncture site; haematemesis or melaena
- Shock: Compensated shock is defined as capillary refill ≥ 3 s or temperature gradient on leg (mid to proximal limb), but no hypotension. Decompensated shock is defined as systolic blood pressure < 70 mm Hg in children or < 80 mm Hg in adults, with evidence of impaired perfusion (cool peripheries or prolonged capillary refill)
- Hyperparasitaemia: P.falciparum parasitaemia > 10%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Greater Mekong Subregion
Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.
Read the detailed description
Malaria Malaria is caused by a mosquito-borne, protozoan parasite belonging to the genus Plasmodium. Of the five species of Plasmodium that infect humans, Plasmodium falciparum is the most deadly and is responsible for the majority of malaria disease and death. Every year, falciparum malaria causes disease in hundreds of millions of people living in the tropics and subtropics, killing a million or more according to some estimates. The vast majority of these deaths occur in sub-Saharan Africa, mostly among young children and infants. When treated with effective antimalarial drugs, malaria can be cured completely.
Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread of drug resistant malaria was a major factor contributing to the failure of the first global malaria eradication campaign in the mid-20th century (1). The widespread implementation of highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to significant gains in global control and elimination efforts and has brought malaria eradication back on the agenda, 40 years after the first global malaria eradication campaign was abandoned (2). However the gains seen in the past decade are now at risk as parasite resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable life of antimalarial drugs by judicious implementation of treatment strategies.
Primary Objective To measure prevalence of established and candidate molecular markers of drug resistant malaria in Greater Mekong Subregion
Secondary Objective To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance in Greater Mekong Subregion
Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211
- Conditions
- Malaria
- Being tested
- Blood Collection, Dried Blood Spot
- Keywords
- Plasmodium falciparum, Prevalence Survey, Antimalarial Drug
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionDiagnostic test
blood smear and/or rapid diagnostic
Dried Blood SpotDiagnostic test
Dried Blood Spot on filter paper
| Study group | Role | What they receive |
|---|---|---|
| Patients Presenting P. falciparum Malaria | Not described Receives: Diagnostic Test: Blood Collection; Diagnostic Test: Dried Blood Spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and geospatial trends of molecular markers, information to assist definition of treatment policies
Measured: 3 years
Secondary outcomes (1)
Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start18 Sep 2017
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
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 University of OxfordThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Worldwide Antimalarial Resistance Network, Mahidol Oxford Tropical Medicine Research Unit, Myanmar Oxford Clinical Research Unit, Shoklo Malaria Research Unit, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Oxford University Clinical Research Unit, Vietnam, Cambodia Oxford Medical Research Unit
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, Prof, Study director, Shoklo Malaria Research UnitFrank Smithuis, Prof, Study director, Myanmar Oxford Clinical Research UnitMayfong Mayxay, Prof, Principal investigator, Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitNguyen Thanh Thuy Nhien, Dr, Principal investigator, Oxford University Clinical Research Unit, VietnamArjen M. Dondorp, PhD, Principal investigator, Mahidol Oxford Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217851
- Sponsor's protocol ID
- BAKMAL 1701
- Status last verified
- May 2022
- First submitted
- 11 Jul 2017
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Greater Mekong Subregion
- ClinicalTrials.gov ID
- NCT03217851
- Acronym / sponsor ID
- BAKMAL 1701
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, Prevalence Survey, Antimalarial Drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol University, Worldwide Antimalarial Resistance Network, Mahidol Oxford Tropical Medicine Research Unit, Myanmar Oxford Clinical Research Unit, Shoklo Malaria Research Unit, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Oxford University Clinical Research Unit, Vietnam, Cambodia Oxford Medical Research Unit
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 14 Jul 2017 (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.
Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.
Detailed description
Malaria Malaria is caused by a mosquito-borne, protozoan parasite belonging to the genus Plasmodium. Of the five species of Plasmodium that infect humans, Plasmodium falciparum is the most deadly and is responsible for the majority of malaria disease and death. Every year, falciparum malaria causes disease in hundreds of millions of people living in the tropics and subtropics, killing a million or more according to some estimates. The vast majority of these deaths occur in sub-Saharan Africa, mostly among young children and infants. When treated with effective antimalarial drugs, malaria can be cured completely.
Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread of drug resistant malaria was a major factor contributing to the failure of the first global malaria eradication campaign in the mid-20th century (1). The widespread implementation of highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to significant gains in global control and elimination efforts and has brought malaria eradication back on the agenda, 40 years after the first global malaria eradication campaign was abandoned (2). However the gains seen in the past decade are now at risk as parasite resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable life of antimalarial drugs by judicious implementation of treatment strategies.
Primary Objective To measure prevalence of established and candidate molecular markers of drug resistant malaria in Greater Mekong Subregion
Secondary Objective To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance in Greater Mekong Subregion
Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Presenting P. falciparum Malaria | – | Diagnostic Test: Blood Collection, Diagnostic Test: Dried Blood Spot |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients age 6 months - 75 years presenting at study site with confirmed P. falciparum infection
Key inclusion criteria (2 listed)
- Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
- Written informed consent obtained (by parents/guardian in case of children less than 18 years old)
Key exclusion criteria (14 listed)
- Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.
- Guideline for the treatment of Malaria-3rd edition, WHO (27) Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P.falciparum asexual parasitaemia.
- Impaired consciousness: A Glasgow comma score < 11 in adults or Blantyre coma score < 3 in children
- Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.
- Multiple convulsions: More than two episodes within 24 h
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 |
|---|---|---|
| Blood Collectionblood smear and/or rapid diagnostic | Diagnostic test | Patients Presenting P. falciparum Malaria |
| Dried Blood SpotDried Blood Spot on filter paper | Diagnostic test | Patients Presenting P. falciparum Malaria |
Primary outcome
Prevalence and geospatial trends of molecular markers, information to assist definition of treatment policies
Time frame: 3 years
1 secondary outcome
Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders
Time frame: 3 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 28 Jun 2022.
- Individual participant dataSharing planned: Yes
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
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
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
Malaria, Intestinal Worms
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.
Francois Nosten, Prof study director
Shoklo Malaria Research Unit
Frank Smithuis, Prof study director
Myanmar Oxford Clinical Research Unit
Mayfong Mayxay, Prof principal investigator
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
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 University of Oxford at 1 site in Thailand.
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 2 inclusion and 14 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 28 Jun 2022. 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 Thailand. 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 and geospatial trends of molecular markers, information to assist definition of treatment policies (time frame: 3 years). 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 28 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.