Malaria,FalciparumPhase 2/3NECTAR1NCT04049916
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission
A Phase 2/3 study testing Pyronaridine Tetraphosphate/Artesunate, Dihydroartemisinin/Piperaquine and Primaquine Diphosphate in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Read more about this study
- Who is it for?
- Ages 5 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Pyronaridine Tetraphosphate/Artesunate, Dihydroartemisinin/Piperaquine and Primaquine Diphosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Sep 2019to 7 Jan 2020
- Phase
- Phase 2/3
- 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 5 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 5 years and ≤ 50 years
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of ≥16 gametocytes/µL (i.e. ≥1 gametocytes recorded in the thick film against 500 white blood cells)
- No allergies to study drugs
- Use of antimalarial drugs over the past 7 days (as reported by the participant)
- Hemoglobin ≥ 9.5 g/dL
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- Individuals weighing >< 80 kg
- No evidence of severe or chronic disease
- Written, informed consent
Who cannot join
- Age < 5 years or > 50 years
- Pregnancy
- Previous reaction to study drugs/known allergy to study drugs
- Signs of severe malaria
- Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine)
- Blood transfusion within the last 90 days
Show all 11Show fewer
- Patients with clinical signs or symptoms of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage B or C).
- Patients with clinical signs or symptoms of renal impairment or known renal impairment
- Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
- Consent not given
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Efficacy and Safety of Pyronaridine-artesunate Combined With Low Dose Primaquine for Preventing Transmission of P. Falciparum Gametocytes in Sub-Saharan Africa
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.
Read the detailed description
Protocol will be shared on request
- Conditions
- Malaria,Falciparum
- Being tested
- Pyronaridine Tetraphosphate/Artesunate, Dihydroartemisinin/Piperaquine, Primaquine Diphosphate
- Keywords
- Primaquine, Pyramax, Euartesim, Dihydroartemisinin-piperaquine, Pyronaridine-artesunate
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyronaridine Tetraphosphate/ArtesunateDrug
Also called Pyramax
Adults: Tablets containing 180 mg pyronaridine-tetraphosphate/60mg artesunate (Pyramax, Shin Poong Pharmaceutical Co.), administered according to weight. Children: Granules containing 60 mg pyronaridine-tetraphosphate/20mg artesunate, administered according to weight.
Dihydroartemisinin/PiperaquineDrug
Also called Euartesim
Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau), administered according to weight.
Primaquine DiphosphateDrug
Also called Primaquine
Extemporaneous preparation of 1mg/mL primaquine phosphate solution, from tablets containing 30mg primaquine (A-PQ 30®, ACE pharmaceuticals, NL) dissolved in 30mL water with a non-interacting fruit-flavoured syrup. Solution will be given at 0.25mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Pyronaridine-artesunate (PA) | Active comparator | Subjects will receive pyronaridine-artesunate (PA) once daily for 3 days. Receives: Drug: Pyronaridine Tetraphosphate/Artesunate |
| PA with single low dose primaquine (PQ) | Experimental | Subjects will receive pyronaridine-artesunate (PA) once daily for 3 days, and a low dose of primaquine (PQ) on the first dat of treatment. PQ dose is at the World Health Organization (WHO) recommended dose of 0.25 mg/kg. Receives: Drug: Pyronaridine Tetraphosphate/Artesunate; Drug: Primaquine Diphosphate |
| Dihydroartemisinin-piperaquine (DP) | Active comparator | Subjects will receive dihydroartemisinin-piperaquine (DP) once daily for 3 days. Receives: Drug: Dihydroartemisinin/Piperaquine |
| DP with single low dose primaquine (PQ) | Active comparator | Subjects will receive dihydroartemisinin-piperaquine (DP) once daily for 3 days., and a low dose of primaquine (PQ) on the first dat of treatment. PQ dose is at the World Health Organization (WHO) recommended dose of 0.25 mg/kg. Receives: Drug: Dihydroartemisinin/Piperaquine; Drug: Primaquine Diphosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mosquito infectivity assessed through membrane feeding assays (day 2)
The proportion of mosquitoes infected, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 2 post feed, compared to baseline
Measured: 2 days (day 0 & 2)
Secondary outcomes (20)
Change in mosquito infectivity assessed through membrane feeding assays (day 7)
The proportion of mosquitoes infected, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 7 post feed, compared to baseline
Measured: 2 days (day 0 & 7)
Mosquito infectivity assessed through membrane feeding assays - inter arm
Mosquito infection prevalence and density, assessed through membrane feeding and measured as oocyst prevalence/density in mosquitoes dissected on day 2 and 7 post feed, compared between study arms
Measured: 3 days (day 0, 2 & 7)
Duration of infectivity
Non PQ arms only: Duration of infectivity will be determined from measures of mosquito infection prevalence, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 0, 2, 7, 10 and 14 post treatment, and then weekly until 2 sequential negative feeds or until day 49.
Measured: 5-10 days (as described)
Area under the curve (AUC) of infectivity/time
Non PQ arms only: AUC will be determined from measures of mosquito infection prevalence and density, assessed through membrane feeding and measured as oocyst prevalence/density in mosquitoes dissected on day 0, 2, 7, 10 and 14 post treatment, and then weekly until 2 sequential negative feeds or until day 49.
Measured: 5-10 days (as described)
Haemoglobin level
Haemolysis will be monitored by measuring haemoglobin levels (g/dL) on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Histidine rich protein 2 (HRP2) concentration
Histidine rich protein 2 (HRP2) protein concentration in plasma will be determined in subsequent lab analysis from samples collected on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Histidine rich protein 2 (HRP2) circulation time
Histidine rich protein 2 (HRP2) protein circulation time will be compared between methods of detection
Measured: 11 days
Histidine rich protein 2 (HRP2) area under the curve (AUC)
Histidine rich protein 2 (HRP2) area under the curve (AUC) will be determined from measures of HRP2 concentration
Measured: 11 days
Rapid diagnostic test result
Varied rapid diagnostic tests based on the detection of HRP2 will be used on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment to determine infection prevalence, for comparison between study arms.
Measured: 11 days
Gametocyte density
Gametocyte density (parasites/microlitre) will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Gametocyte under the curve (AUC)
Gametocyte area under the curve (AUC) will be determined from measures of density.
Measured: 11 days
Gametocyte prevalence
Gametocyte prevalence (parasites/microlitre) will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Gametocyte circulation time
Gametocyte circulation time (days) will be determined from measures of prevalence.
Measured: 11 days
Gametocyte sex ratio
Gametocyte density will be determined by molecular methods for males and females separately, allowing analysis of sex ratio (proportion of total that is male) on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Asexual parasite density
Asexual parasite density (parasites/microlitre) will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Asexual parasite area under the curve (AUC)
Asexual parasite area under the curve (AUC) will be determined from measures of density.
Measured: 11 days
Asexual parasite prevalence
Asexual parasite prevalence (parasites/microlitre) will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 10, 14, 21, 38, 35, 42 and 49 post treatment.
Measured: 11 days
Asexual parasite circulation time
Asexual parasite circulation time (days) will be determined from measures of prevalence.
Measured: 11 days
Parasite genotype
Parasite merozoite surface protein 2 (MSP2) allelic diversity (presence of distinct alleles) will be determined in subsequent lab analysis from whole blood samples collected at baseline.
Measured: 1 day
Histidine rich protein gene deletion
Deletion (presence/absence) of the HRP2/3 genes will be determined from whole blood samples collected at baseline.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start12 Sep 2019
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
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 Malaria,FalciparumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049916
- Sponsor's protocol ID
- 17507
- Other IDs
- INV-002098
- Acronym
- NECTAR1
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised individual participant data may be shared on a digital repository or upon reasonable request
Publications
Stone W, Mahamar A, Sanogo K, Sinaba Y, Niambele SM, Sacko A, Keita S, Youssouf A, Diallo M, Soumare HM, Kaur H, Lanke K, Ter Heine R, Bradley J, Issiaka D, Diawara H, Traore SF, Bousema T, Drakeley C, Dicko A. Pyronaridine-artesunate or dihydroartemisinin-piperaquine combined with single low-dose primaquine to prevent Plasmodium falciparum malaria transmission in Ouelessebougou, Mali: a four-arm, single-blind, phase 2/3, randomised trial. Lancet Microbe. 2022 Jan;3(1):e41-e51. doi: 10.1016/S2666-5247(21)00192-0.
PubMed 35028628
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pyronaridine-artesunate Combined With Low Dose Primaquine for Preventing Transmission of P. Falciparum Gametocytes in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT04049916
- Acronym / sponsor ID
- NECTAR1 / 17507
- Conditions
- Malaria,Falciparum
- Keywords
- Primaquine, Pyramax, Euartesim, Dihydroartemisinin-piperaquine, Pyronaridine-artesunate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Radboud University Medical Center
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 8 Aug 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.
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.
Detailed description
Protocol will be shared on request
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pyronaridine-artesunate (PA) | Active comparator | Drug: Pyronaridine Tetraphosphate/ArtesunateSubjects will receive pyronaridine-artesunate (PA) once daily for 3 days. |
| PA with single low dose primaquine (PQ) | Experimental | Drug: Pyronaridine Tetraphosphate/Artesunate, Drug: Primaquine DiphosphateSubjects will receive pyronaridine-artesunate (PA) once daily for 3 days, and a low dose of primaquine (PQ) on the first dat of treatment. PQ dose is at the World Health Organization (WHO) recommended dose of 0.25 mg/kg. |
| Dihydroartemisinin-piperaquine (DP) | Active comparator | Drug: Dihydroartemisinin/PiperaquineSubjects will receive dihydroartemisinin-piperaquine (DP) once daily for 3 days. |
| DP with single low dose primaquine (PQ) | Active comparator | Drug: Dihydroartemisinin/Piperaquine, Drug: Primaquine DiphosphateSubjects will receive dihydroartemisinin-piperaquine (DP) once daily for 3 days., and a low dose of primaquine (PQ) on the first dat of treatment. PQ dose is at the World Health Organization (WHO) recommended dose of 0.25 mg/kg. |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age ≥ 5 years and ≤ 50 years
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of ≥16 gametocytes/µL (i.e. ≥1 gametocytes recorded in the thick film against 500 white blood cells)
- No allergies to study drugs
- Use of antimalarial drugs over the past 7 days (as reported by the participant)
Key exclusion criteria (11 listed)
- Age < 5 years or > 50 years
- Pregnancy
- Previous reaction to study drugs/known allergy to study drugs
- Signs of severe malaria
- Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine)
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 |
|---|---|---|
| Pyronaridine Tetraphosphate/ArtesunateAlso: PyramaxAdults: Tablets containing 180 mg pyronaridine-tetraphosphate/60mg artesunate (Pyramax, Shin Poong Pharmaceutical Co.), administered according to weight. Children: Granules containing 60 mg pyronaridine-tetraphosphate/20mg artesunate, administered according to weight. | Drug | PA with single low dose primaquine (PQ), Pyronaridine-artesunate (PA) |
| Dihydroartemisinin/PiperaquineAlso: EuartesimTablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau), administered according to weight. | Drug | DP with single low dose primaquine (PQ), Dihydroartemisinin-piperaquine (DP) |
| Primaquine DiphosphateAlso: PrimaquineExtemporaneous preparation of 1mg/mL primaquine phosphate solution, from tablets containing 30mg primaquine (A-PQ 30®, ACE pharmaceuticals, NL) dissolved in 30mL water with a non-interacting fruit-flavoured syrup. Solution will be given at 0.25mg/kg. | Drug | DP with single low dose primaquine (PQ), PA with single low dose primaquine (PQ) |
Primary outcome
Change in mosquito infectivity assessed through membrane feeding assays (day 2)
Time frame: 2 days (day 0 & 2)
The proportion of mosquitoes infected, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 2 post feed, compared to baseline
20 secondary outcomes
Change in mosquito infectivity assessed through membrane feeding assays (day 7)
Time frame: 2 days (day 0 & 7)
Mosquito infectivity assessed through membrane feeding assays - inter arm
Time frame: 3 days (day 0, 2 & 7)
Duration of infectivity
Time frame: 5-10 days (as described)
Area under the curve (AUC) of infectivity/time
Time frame: 5-10 days (as described)
Haemoglobin level
Time frame: 11 days
Histidine rich protein 2 (HRP2) concentration
Time frame: 11 days
Histidine rich protein 2 (HRP2) circulation time
Time frame: 11 days
Histidine rich protein 2 (HRP2) area under the curve (AUC)
Time frame: 11 days
Rapid diagnostic test result
Time frame: 11 days
Gametocyte density
Time frame: 11 days
Gametocyte under the curve (AUC)
Time frame: 11 days
Gametocyte prevalence
Time frame: 11 days
Gametocyte circulation time
Time frame: 11 days
Gametocyte sex ratio
Time frame: 11 days
Asexual parasite density
Time frame: 11 days
Asexual parasite area under the curve (AUC)
Time frame: 11 days
Asexual parasite prevalence
Time frame: 11 days
Asexual parasite circulation time
Time frame: 11 days
Parasite genotype
Time frame: 1 day
Histidine rich protein gene deletion
Time frame: 1 day
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 30 Jan 2020.
- Derived from this study: PubMed 35028628Stone W, Mahamar A, Sanogo K, Sinaba Y, Niambele SM, Sacko A, Keita S, Youssouf A, Diallo M, Soumare HM, Kaur H, Lanke K, Ter Heine R, Bradley J, Issiaka D, Diawara H, Traore SF, Bousema T, Drakeley C, Dicko A. Pyronaridine-artesunate or dihydroartemisinin-piperaquine combined with single low-dose primaquine to prevent Plasmodium falciparum malaria transmission in Ouelessebougou, Mali: a four-arm, single-blind, phase 2/3, randomised trial. Lancet Microbe. 2022 Jan;3(1):e41-e51. doi: 10.1016/S2666-5247(21)00192-0.
- Individual participant dataSharing planned: No. Anonymised individual participant data may be shared on a digital repository or upon reasonable request
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pyronaridine Tetraphosphate/Artesunate, Dihydroartemisinin/Piperaquine and Primaquine Diphosphate in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 9 inclusion and 11 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 30 Jan 2020. 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 Mali, Netherlands. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in mosquito infectivity assessed through membrane feeding assays (day 2) (time frame: 2 days (day 0 & 2)). 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 NCT04049916, 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 30 Jan 2020.