MalariaPhase 4NCT04079621
Short Course Radical Cure of P. Vivax Malaria in Nepal
A Phase 4 study testing primaquine in people with Malaria and Malaria, Vivax, run by Menzies School of Health Research at 2 sites in Nepal.
Trial summary
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malaria, Malaria, Vivax, Malaria,Falciparum
- What is being tested?
- primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesNepal
- Study dates
- 27 Oct 2021to 31 Mar 2024
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- P. falciparum and/or vivax infection
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Age >1 years
- G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines
- Written informed consent
- Able to comply with all study procedures and timelines
Who cannot join
- General danger signs or symptoms of severe malaria
- Anaemia, defined as Hb <8g/dl
- Pregnant women as determined by Urine β-HCG pregnancy test
- Breast feeding women
- Known hypersensitivity to any of the drugs given
- Regular use of drugs with haemolytic potential
- Blood transfusion within the last 4 months
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Short Course Radical Cure of P.Vivax in Nepal- a Randomized Controlled Trial
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
Read the detailed description
Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite.
In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.
The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
- Conditions
- Malaria, Malaria, Vivax, Malaria,Falciparum
- Being tested
- primaquine
- Medical subject headings
- Malaria, Malaria, Vivax, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primaquineDrug
Also called Jasoprim, Malirid, Neo-Quipenyl, Pimaquin, Pmq, Primachina, Primacin, Primaquina, Primaquine, Primaquine diphosphate, Primaquine Phosphate, and Remaquin
Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)
| Study group | Role | What they receive |
|---|---|---|
| (P.f) | Experimental | patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days plus a low dose course of primaquine (PQ) (3.5mg/kg total dose) given 7 days during schizontocidal treatment Receives: Drug: primaquine |
| (P.v) | Experimental | patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (3.5mg/kg total dose) given over 7 days during schizontocidal treatment. Receives: Drug: primaquine |
| Standard care (P.f) | No intervention | patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days (plus a single dose PQ) |
| Standard care (P.v) | No intervention | patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (total dose 3.5mg/kg) over 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Risk of P. vivax relapse at month 6
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.
Measured: 6 months
Secondary outcomes (5)
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax
Measured: 6 months
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum
Measured: 6 month
The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Measured: Day 28
The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Measured: Day 28
The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start27 Oct 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University, Nepal
- Responsible party
- Sponsor
- Investigators
- Kamala Ley-Thriemer, MD, PhD, Principal investigator, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079621
- Sponsor's protocol ID
- SIRIN
- Status last verified
- Aug 2024
- First submitted
- 3 Sep 2019
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan will be made available to others. Data collected for the study, including individual patient data and the final trial dataset are reserved for the chief investigator and co-investigators of the trial. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Trial results will be published in peer-reviewed open access journals and disseminated to trial stakeholders, including participants, as per ethical guidelines.
Publications
Ghimire P, Dahal G, Adhikari N, Rijal KR, Adhikari S, Banjara MR, Mnjala H, Lee G, Weston S, Rumaseb A, Rai A, Ley B, Hossain MS, Simpson JA, Rajasekhar M, Adhikari B, Price RN, Lal BK, Thriemer K. Short-Course Low-Dose Primaquine for Radical Cure in G6PD-Normal Patients in the Pre-Elimination Context of Nepal. Trop Med Int Health. 2026 Aug;31(8):1028-1034. doi: 10.1111/tmi.70145. Epub 2026 Apr 25.
PubMed 42033147
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Radical Cure of P.Vivax in Nepal- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04079621
- Acronym / sponsor ID
- SIRIN
- Conditions
- Malaria, Malaria, Vivax, Malaria,Falciparum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Tribhuvan University, Nepal
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Sep 2019 (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.
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
Detailed description
Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite.
In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.
The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (P.f) | Experimental | Drug: primaquinepatients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days plus a low dose course of primaquine (PQ) (3.5mg/kg total dose) given 7 days during schizontocidal treatment |
| (P.v) | Experimental | Drug: primaquinepatients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (3.5mg/kg total dose) given over 7 days during schizontocidal treatment. |
| Standard care (P.f) | No intervention | –patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days (plus a single dose PQ) |
| Standard care (P.v) | No intervention | –patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (total dose 3.5mg/kg) over 14 days |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- P. falciparum and/or vivax infection
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Age >1 years
- G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines
- Written informed consent
Key exclusion criteria (7 listed)
- General danger signs or symptoms of severe malaria
- Anaemia, defined as Hb <8g/dl
- Pregnant women as determined by Urine β-HCG pregnancy test
- Breast feeding women
- Known hypersensitivity to any of the drugs given
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 |
|---|---|---|
| primaquineAlso: Jasoprim, Malirid, Neo-Quipenyl, Pimaquin, Pmq, Primachina, Primacin, Primaquina, Primaquine, Primaquine diphosphate, Primaquine Phosphate, and RemaquinPrimaquine regimen over 7 days (0.5mg/kg/day for 7 days) | Drug | (P.f), (P.v) |
Primary outcome
Incidence Risk of P. vivax relapse at month 6
Time frame: 6 months
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.
5 secondary outcomes
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax
Time frame: 6 months
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum
Time frame: 6 month
The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Time frame: Day 28
The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Time frame: Day 28
The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection
Time frame: Day 28
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 29 Aug 2024.
- Derived from this study: PubMed 42033147Ghimire P, Dahal G, Adhikari N, Rijal KR, Adhikari S, Banjara MR, Mnjala H, Lee G, Weston S, Rumaseb A, Rai A, Ley B, Hossain MS, Simpson JA, Rajasekhar M, Adhikari B, Price RN, Lal BK, Thriemer K. Short-Course Low-Dose Primaquine for Radical Cure in G6PD-Normal Patients in the Pre-Elimination Context of Nepal. Trop Med Int Health. 2026 Aug;31(8):1028-1034. doi: 10.1111/tmi.70145. Epub 2026 Apr 25.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan will be made available to others. Data collected for the study, including individual patient data and the final trial dataset are reserved for the chief investigator and co-investigators of the trial. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Trial results will be published in peer-reviewed open access journals and disseminated to trial stakeholders, including participants, as per ethical guidelines.
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.
Kamala Ley-Thriemer, MD, PhD principal investigator
Menzies School of Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing primaquine in people with Malaria and Malaria, Vivax, run by Menzies School of Health Research at 2 sites in Nepal.
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 6 inclusion and 7 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 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. 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?
Incidence Risk of P. vivax relapse at month 6 (time frame: 6 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 NCT04079621, 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 29 Aug 2024.