MalariaPhase 4NCT02742285
Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot
A Phase 4 study testing Artemether + lumefantrine in people with Malaria, run by Thierry Buclin at 1 site in Switzerland.
Trial summary
Measurement of the concentration of antimalarials in the blood of the general population helps estimating the overall drug pressure and is used in efficacy studies. The current sampling standard for drug measurement is plasma obtained by venous puncture. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether + lumefantrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Sep 2016
- Phase
- Phase 4
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of current drug treatment (except hormonal contraception, an additional barrier method is strongly advised)
- 12-lead ECG without significant abnormalities
- The subject understands the procedures, agrees to participate and is willing to give written informed consent
- The subject agrees to be available for at least 5 blood sampling after drug administration, at scheduled time points.
Who cannot join
- History of any major medical disorder
- Any recent acute illness which could expose the subject to a higher risk or might confound the results of the study
- Current pregnancy or breast-feeding
- Congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the corrected QT interval
- Family history of congenital prolongation of the QT interval or sudden death
- Known disturbances of electrolyte balance
Show all 17Show fewer
- Known liver disorder of any type, even if no medical treatment is needed. Gilbert syndrome will be tolerated, if mild
- Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
- History of hypersensitivity to any component of the drug
- History of hypersensitivity to any drug if considered as serious
- History of alcohol or drug abuse
- Present consumption of a large quantity of alcohol or wine (>0.5 L wine/day) or equivalent. Consumption of reasonable amount of wine (0.3 L) or of beer is acceptable, except between Day -1 to Day 3 of drug administration
- Use of any medication the week prior to study or as based on 5 plasma half-life rule and up to 48 hours post drug administration
- Participation in a clinical trial in the previous 3 months unless no treatment provided and low amount of blood collected
- Occupation which might interfere with visits and blood sampling during the study
- Psychological status which could have an impact on subject's ability to give informed consent
- Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate their interpretation or represent a potential risk for the subject
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Clinical Pharmacology
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of Lumefantrine Concentrations Measured in Venous Plasma Versus in Dried Capillary Blood Spot Samples in Healthy Volunteers.
Measurement of the concentration of antimalarials in the blood of the general population helps estimating the overall drug pressure and is used in efficacy studies. The current sampling standard for drug measurement is plasma obtained by venous puncture. The use of a Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions easier, but concordance with usual venous sampling is not yet established.
The current work will allow validating the concentrations of lumefantrine measured in the DBS samples collected during the field trials and validate the use of DBS for future studies. In addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations supplies throughout most malaria endemic countries, this study may improve our understanding of lumefantrine and artemether distribution in the blood compartments and generate knowledge for further developing analytical methods for drug measurement.
Read more
The overall purpose of this study is to validate the dried blood spots as a sampling method for the analysis of lumefantrine.
The primary objective is to assess the concordance between lumefantrine plasma and dried blood spots (DBS) concentrations.
The investigators also aim at describing lumefantrine's distribution in the different blood compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total in whole blood.
Read the detailed description
(Details available on request)
- Conditions
- Malaria
- Being tested
- Artemether + lumefantrine
- Keywords
- antimalarials, blood samples, drug concentrations, pharmacokinetics, lumefantrine, healthy volunteers
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether + lumefantrineDrug
Also called (Riamet)
A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer.
| Study group | Role | What they receive |
|---|---|---|
| Artemether + lumefantrine | Other | One single adult dose of artemether + lumefantrine 80 + 480 mg Receives: Drug: Artemether + lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of concentrations of lumefantrine measured in dried capillary blood spot samples (DBS) and in plasma, at different time-points after the administration of a single oral adult dose of artemether-lumefantrine.
Measured: Within the first two weeks after drug intake
Secondary outcomes (7)
Concordance of concentrations of desbutyl-lumefantrine measured in DBS and in plasma
Measured: Within the first two weeks after drug intake
Concordance of lumefantrine and desbutyl-lumefantrine concentrations measured in dried venous blood spot samples and in plasma
Measured: Within the first two weeks after drug intake
Concordance of concentration of lumefantrine and desbutyl-lumefantrine measured in whole venous blood and in plasma
Measured: Within the first two weeks after drug intake
Determination of a ratio of intra-erythrocyte and plasma concentrations of lumefantrine and desbutyl-lumefantrine over time (corrected for hematocrit)
Measured: Within the first two weeks after drug intake
Determination of a ratio of unbound plasma concentration and total plasma concentration of lumefantrine and desbutyl-lumefantrine over time
Measured: Within the first two weeks after drug intake
Determination of the limit of quantification of artemether and dihydroartemisinin in dried blood spots samples, using the standard method of a calibration curve
Measured: Within the first 24 hours after drug intake
Determination the relative precision of lumefantrine and desbutyl-lumefantrine concentrations in dried blood spots versus in plasma, using triplicate measurements and a hierarchical non-linear regression model
Measured: Within the first two weeks after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionSep 2016
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thierry Buclin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thierry Buclin, Centre Hospitalier Universitaire Vaudois
- Investigators
- Thierry Buclin, Professor, Principal investigator, Division of Clinical Pharmacology, University Hospital, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742285
- Sponsor's protocol ID
- DBS-ALU
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2016
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lumefantrine Concentrations Measured in Venous Plasma Versus in Dried Capillary Blood Spot Samples in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02742285
- Acronym / sponsor ID
- DBS-ALU
- Conditions
- Malaria
- Keywords
- antimalarials, blood samples, drug concentrations, pharmacokinetics, lumefantrine, healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Thierry BuclinUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Apr 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.
Measurement of the concentration of antimalarials in the blood of the general population helps estimating the overall drug pressure and is used in efficacy studies. The current sampling standard for drug measurement is plasma obtained by venous puncture. The use of a Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions easier, but concordance with usual venous sampling is not yet established.
The current work will allow validating the concentrations of lumefantrine measured in the DBS samples collected during the field trials and validate the use of DBS for future studies. In addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations supplies throughout most malaria endemic countries, this study may improve our understanding of lumefantrine and artemether distribution in the blood compartments and generate knowledge for further developing analytical methods for drug measurement.
The overall purpose of this study is to validate the dried blood spots as a sampling method for the analysis of lumefantrine.
The primary objective is to assess the concordance between lumefantrine plasma and dried blood spots (DBS) concentrations.
The investigators also aim at describing lumefantrine's distribution in the different blood compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total in whole blood.
Detailed description
(Details available on request)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artemether + lumefantrine | Other | Drug: Artemether + lumefantrineOne single adult dose of artemether + lumefantrine 80 + 480 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Absence of current drug treatment (except hormonal contraception, an additional barrier method is strongly advised)
- 12-lead ECG without significant abnormalities
- The subject understands the procedures, agrees to participate and is willing to give written informed consent
- The subject agrees to be available for at least 5 blood sampling after drug administration, at scheduled time points.
Key exclusion criteria (17 listed)
- History of any major medical disorder
- Any recent acute illness which could expose the subject to a higher risk or might confound the results of the study
- Current pregnancy or breast-feeding
- Congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the corrected QT interval
- Family history of congenital prolongation of the QT interval or sudden death
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 |
|---|---|---|
| Artemether + lumefantrineAlso: (Riamet)A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer. | Drug | Artemether + lumefantrine |
Primary outcome
Concordance of concentrations of lumefantrine measured in dried capillary blood spot samples (DBS) and in plasma, at different time-points after the administration of a single oral adult dose of artemether-lumefantrine.
Time frame: Within the first two weeks after drug intake
7 secondary outcomes
Concordance of concentrations of desbutyl-lumefantrine measured in DBS and in plasma
Time frame: Within the first two weeks after drug intake
Concordance of lumefantrine and desbutyl-lumefantrine concentrations measured in dried venous blood spot samples and in plasma
Time frame: Within the first two weeks after drug intake
Concordance of concentration of lumefantrine and desbutyl-lumefantrine measured in whole venous blood and in plasma
Time frame: Within the first two weeks after drug intake
Determination of a ratio of intra-erythrocyte and plasma concentrations of lumefantrine and desbutyl-lumefantrine over time (corrected for hematocrit)
Time frame: Within the first two weeks after drug intake
Determination of a ratio of unbound plasma concentration and total plasma concentration of lumefantrine and desbutyl-lumefantrine over time
Time frame: Within the first two weeks after drug intake
Determination of the limit of quantification of artemether and dihydroartemisinin in dried blood spots samples, using the standard method of a calibration curve
Time frame: Within the first 24 hours after drug intake
Determination the relative precision of lumefantrine and desbutyl-lumefantrine concentrations in dried blood spots versus in plasma, using triplicate measurements and a hierarchical non-linear regression model
Time frame: Within the first two weeks after drug intake
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 16 Jan 2018.
- 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
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
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
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Thierry Buclin, Professor principal investigator
Division of Clinical Pharmacology, University Hospital, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether + lumefantrine in people with Malaria, run by Thierry Buclin at 1 site in Switzerland.
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 17 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 16 Jan 2018. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Concordance of concentrations of lumefantrine measured in dried capillary blood spot samples (DBS) and in plasma, at different time-points after the administration of a single oral adult dose of artemether-lumefantrine. (time frame: Within the first two weeks after drug intake). 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 16 Jan 2018.