Plasmodium FalciparumNCT02895568
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers
An observational study of Plasmodium Falciparum, run by University of Oxford at 1 site in Chad.
Trial summary
This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Plasmodium Falciparum
- How many people
- 399 participants
- Where
- 1 siteChad
- Study dates
- 16 Sep 2016to 6 Sep 2018
- 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: Study participants will be the patients presenting at study clinics with signs and symptoms of malaria (including but not limited to headache, body aches, fever, chills, and weakness) and confirmed P. falciparum infection.
Who may be able to join
- Participants must meet all of the inclusion criteria to participate in the study.
- Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
- Written informed consent obtained
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.
Trial locations and contacts
1 site in 1 country.
Chad1 site
Study clinic
Komé, Doba
About this study
Official title: Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad
This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.
Read the detailed description
This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400.
Prospective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.
- Conditions
- Plasmodium Falciparum
- Keywords
- Antimalarial drug, Resistance, Republic of Chard
- Medical subject headings
- Malaria, Falciparum
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)
Measured: 2 years
Secondary outcomes (2)
Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)
Measured: 2 years
Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders
Measured: 2 yeas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start16 Sep 2016
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
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 Plasmodium FalciparumStudies 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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Worldwide Antimalarial Resistance Network, Mahidol University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895568
- Sponsor's protocol ID
- WWARN1603
- Status last verified
- Nov 2018
- First submitted
- 22 Aug 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Das S, Kerah-Hinzoumbe C, Kebfene M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guerin PJ, Imwong M, Dhorda M. Molecular surveillance for operationally relevant genetic polymorphisms in Plasmodium falciparum in Southern Chad, 2016-2017. Malar J. 2022 Mar 12;21(1):83. doi: 10.1186/s12936-022-04095-9.
PubMed 35279140
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 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 Komé, Doba, Republic of Chad
- ClinicalTrials.gov ID
- NCT02895568
- Acronym / sponsor ID
- WWARN1603
- Conditions
- Plasmodium Falciparum
- Keywords
- Antimalarial drug, Resistance, Republic of Chard
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Worldwide Antimalarial Resistance Network, Mahidol University
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 9 Sep 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.
This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.
Detailed description
This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400.
Prospective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be the patients presenting at study clinics with signs and symptoms of malaria (including but not limited to headache, body aches, fever, chills, and weakness) and confirmed P. falciparum infection.
Key inclusion criteria (3 listed)
- Participants must meet all of the inclusion criteria to participate in the study.
- Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
- Written informed consent obtained
Key exclusion criteria (1 listed)
- Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.
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
Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)
Time frame: 2 years
2 secondary outcomes
Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)
Time frame: 2 years
Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders
Time frame: 2 yeas
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 7 Apr 2022.
- Background: PubMed 35279140Das S, Kerah-Hinzoumbe C, Kebfene M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guerin PJ, Imwong M, Dhorda M. Molecular surveillance for operationally relevant genetic polymorphisms in Plasmodium falciparum in Southern Chad, 2016-2017. Malar J. 2022 Mar 12;21(1):83. doi: 10.1186/s12936-022-04095-9.
- 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.
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 Plasmodium Falciparum, run by University of Oxford at 1 site in Chad.
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 1 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 7 Apr 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 Chad. 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?
Percent prevalence of kelch13 mutants (marker of resistance to artemisinins) (time frame: 2 years). 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 NCT02895568, 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 7 Apr 2022.