Plasmodium VivaxPhase 1/2Lao PvNCT02802813
P.Vivax Treatment Trial
A Phase 1/2 study testing Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) in people with Plasmodium Vivax, run by University of Oxford at 1 site in Laos.
Trial summary
This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Plasmodium Vivax
- What is being tested?
- Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteLaos
- Study dates
- 14 Jun 2016to 15 Jun 2018
- Phase
- Phase 1/2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with subclinical mono- or mixed P. vivax infections (uPCR) can be enrolled.
- Able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up.
- A participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial.
Who cannot join
- Currently pregnant or breastfeeding (female of child-bearing age).
- Inability to tolerate oral treatment.
- Previous episode of haemolysis or severe haemoglobinuria following primaquine.
- Known hypersensitivity or allergy to the study drugs.
- Blood transfusion in last 90 days, since this can mask G6PD deficiency.
- An acute malaria episode requiring treatment.
Show all 10Show fewer
- A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration).
- Anaemia (Haemoglobin (Hb) < 9 g/dL
- Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal or hepatic disease; severe malnutrition; HIV/AIDS; or severe febrile condition other than malaria); co-administration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens.
- Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blinded Controlled Treatment Trial of Subclinical Vivax Infections With Primaquine in Nong Province, Laos
This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).
Read the detailed description
This is a randomized, Single blind trial in G6PD normal participants with subclinical P. vivax infections in Laos. Participants with subclinical P. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms:
- Intervention: Dihydroartemisinin-piperaquine (DP) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day).
- Control arm: Dihydroartemisinin-piperaquine (DP) 3 days dosing therapy plus 14 days identical primaquine placebo.
Participants found to be G6PD deficient (G6PDd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to WHO recommendations. Primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. All doses of study drugs will be supervised. If participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing.
Findings:
The study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic P. vivax infections (doi: 10.1186/s12936-019-3091-5)
- Conditions
- Plasmodium Vivax
- Being tested
- Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ), Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placebo
- Keywords
- Single-blinded controlled trial, Primaquine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)Drug
Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Dihydroartemisinin-piperaquine (DP) therapy plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg). Receives: Drug: Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) |
| Control arm | Placebo comparator | Dihydroartemisinin-piperaquine therapy plus 14 days identical placebo not containing primaquine. Receives: Drug: Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of P. vivax parasitaemia in G6PD-normal participants
the incidence rate will be detected by uPCR
Measured: over 12 months
Secondary outcomes (9)
Time to P. vivax clearance
Detected by uPCR
Measured: 12 months
The frequency of recurrent vivax infections (clinical and sub-clinical)
Measured: 12 months
The follow-up period required to detect a statistically significant difference in the frequency of recurrent subclinical P. vivax infections between treated and untreated participants
measured by uPCR
Measured: 12 months
Number of participants with treatment related Adverse event.
Measured: 28 days
Number of participants with treatment related malaria episode
Measured: 12 months
Number of doses taken per participants
Measured: 14 days
Compare the percentage decrease in hemoglobin between those who receive primaquine and who those not receive primaquine
Measured: 12 months
Number of G6PD genotypes in participants with G6PD deficiency
Measured: 12 months
Number of P450 genotypes in participants with recurrent PV infection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start14 Jun 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plasmodium VivaxStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Mayfong Mayxay, MD, Principal investigator, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802813
- Sponsor's protocol ID
- LOMWRU1601
- Acronym
- Lao Pv
- Status last verified
- Aug 2017
- First submitted
- 27 May 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Phommasone K, van Leth F, Imwong M, Henriques G, Pongvongsa T, Adhikari B, Peto TJ, Promnarate C, Dhorda M, Sirithiranont P, Mukaka M, Peerawaranun P, Day NPJ, Cobelens F, Dondorp AM, Newton PN, White NJ, von Seidlein L, Mayxay M. The use of ultrasensitive quantitative-PCR to assess the impact of primaquine on asymptomatic relapse of Plasmodium vivax infections: a randomized, controlled trial in Lao PDR. Malar J. 2020 Jan 3;19(1):4. doi: 10.1186/s12936-019-3091-5.
PubMed 31900172von Seidlein L, Peerawaranun P, Mukaka M, Nosten FH, Nguyen TN, Hien TT, Tripura R, Peto TJ, Pongvongsa T, Phommasone K, Mayxay M, Imwong M, Watson J, Pukrittayakamee S, Day NPJ, Dondorp AM. The probability of a sequential Plasmodium vivax infection following asymptomatic Plasmodium falciparum and P. vivax infections in Myanmar, Vietnam, Cambodia, and Laos. Malar J. 2019 Dec 30;18(1):449. doi: 10.1186/s12936-019-3087-1.
PubMed 31888643
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blinded Controlled Treatment Trial of Subclinical Vivax Infections With Primaquine in Nong Province, Laos
- ClinicalTrials.gov ID
- NCT02802813
- Acronym / sponsor ID
- Lao Pv / LOMWRU1601
- Conditions
- Plasmodium Vivax
- Keywords
- Single-blinded controlled trial, Primaquine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 16 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.
This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).
Detailed description
This is a randomized, Single blind trial in G6PD normal participants with subclinical P. vivax infections in Laos. Participants with subclinical P. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms:
- Intervention: Dihydroartemisinin-piperaquine (DP) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day).
- Control arm: Dihydroartemisinin-piperaquine (DP) 3 days dosing therapy plus 14 days identical primaquine placebo.
Participants found to be G6PD deficient (G6PDd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to WHO recommendations. Primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. All doses of study drugs will be supervised. If participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing.
Findings:
The study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic P. vivax infections (doi: 10.1186/s12936-019-3091-5)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Drug: Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)Dihydroartemisinin-piperaquine (DP) therapy plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg). |
| Control arm | Placebo comparator | Drug: Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placeboDihydroartemisinin-piperaquine therapy plus 14 days identical placebo not containing primaquine. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with subclinical mono- or mixed P. vivax infections (uPCR) can be enrolled.
- Able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up.
- A participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial.
Key exclusion criteria (10 listed)
- Currently pregnant or breastfeeding (female of child-bearing age).
- Inability to tolerate oral treatment.
- Previous episode of haemolysis or severe haemoglobinuria following primaquine.
- Known hypersensitivity or allergy to the study drugs.
- Blood transfusion in last 90 days, since this can mask G6PD deficiency.
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 |
|---|---|---|
| Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) | Drug | Intervention arm |
| Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placebo | Drug | Control arm |
Primary outcome
The incidence rate of P. vivax parasitaemia in G6PD-normal participants
Time frame: over 12 months
the incidence rate will be detected by uPCR
9 secondary outcomes
Time to P. vivax clearance
Time frame: 12 months
The frequency of recurrent vivax infections (clinical and sub-clinical)
Time frame: 12 months
The follow-up period required to detect a statistically significant difference in the frequency of recurrent subclinical P. vivax infections between treated and untreated participants
Time frame: 12 months
Number of participants with treatment related Adverse event.
Time frame: 28 days
Number of participants with treatment related malaria episode
Time frame: 12 months
Number of doses taken per participants
Time frame: 14 days
Compare the percentage decrease in hemoglobin between those who receive primaquine and who those not receive primaquine
Time frame: 12 months
Number of G6PD genotypes in participants with G6PD deficiency
Time frame: 12 months
Number of P450 genotypes in participants with recurrent PV infection.
Time frame: 12 months
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 2 Mar 2022.
- Derived from this study: PubMed 31900172Phommasone K, van Leth F, Imwong M, Henriques G, Pongvongsa T, Adhikari B, Peto TJ, Promnarate C, Dhorda M, Sirithiranont P, Mukaka M, Peerawaranun P, Day NPJ, Cobelens F, Dondorp AM, Newton PN, White NJ, von Seidlein L, Mayxay M. The use of ultrasensitive quantitative-PCR to assess the impact of primaquine on asymptomatic relapse of Plasmodium vivax infections: a randomized, controlled trial in Lao PDR. Malar J. 2020 Jan 3;19(1):4. doi: 10.1186/s12936-019-3091-5.
- Derived from this study: PubMed 31888643von Seidlein L, Peerawaranun P, Mukaka M, Nosten FH, Nguyen TN, Hien TT, Tripura R, Peto TJ, Pongvongsa T, Phommasone K, Mayxay M, Imwong M, Watson J, Pukrittayakamee S, Day NPJ, Dondorp AM. The probability of a sequential Plasmodium vivax infection following asymptomatic Plasmodium falciparum and P. vivax infections in Myanmar, Vietnam, Cambodia, and Laos. Malar J. 2019 Dec 30;18(1):449. doi: 10.1186/s12936-019-3087-1.
- Individual participant dataSharing planned: Yes
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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.
Mayfong Mayxay, MD 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?
A Phase 1/2 study testing Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) in people with Plasmodium Vivax, run by University of Oxford at 1 site in Laos.
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 10 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 2 Mar 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 Laos. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The incidence rate of P. vivax parasitaemia in G6PD-normal participants (time frame: over 12 months). 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 NCT02802813, which also lists 2 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 2 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.