Malaria, FalciparumPhase 2NECTAR2NCT04609098
Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
A Phase 2 study testing Dihydroartemisinin/Piperaquine and Tafenoquine 100mg [Arakoda] in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Mali.
Trial summary
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Dihydroartemisinin/Piperaquine and Tafenoquine 100mg [Arakoda]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMali
- Study dates
- 29 Oct 2020to 23 Dec 2020
- Phase
- Phase 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 12 years and ≤ 50 years
- Glucose 6 phosphate dehydrogenase (G6PD) normal status defined by Carestart rapid diagnostic test or the G6PD qualitative test (OSMMR2000)
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells)
- Absence of other non-P. falciparum species on blood film
- No allergies to study drugs
Show all 11Show fewer
- No use of antimalarial drugs over the past 7 days (as reported by the participant)
- Hemoglobin ≥ 10 g/dL
- Individuals weighing < = 80 kg
- No evidence of acute severe or chronic disease
- Written, informed consent
Who cannot join
- Age < 12 years or > 50 years
- Women who are pregnant or lactating
- Blood thick film negative for sexual stages of malaria
- Detection of a non-P. falciparum species by microscopy
- Previous reaction to study drugs / known allergy to study drugs
- Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL)
Show all 20Show fewer
- Signs of acute or chronic illness, including hepatitis
- The use of other medication (with the exception of paracetamol and/or aspirin)
- Consent not given
- G6PD-deficiency by Carestart rapid diagnostic test or the OSMMR2000 G6PD qualitative test
- Use of antimalarial drugs over the past 7 days (as reported by the participant)
- The use of other medication (with the exception of paracetamol and/or aspirin)
- Clinically significant illness (intercurrent illness e.g. pneumonia, pre-existing condition e.g. renal disease, malignancy or conditions that may affect absorption of study medication e.g. severe diarrhea or any signs of malnutrition as defined clinically)
- Signs 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)
- Signs, symptoms or known renal impairment
- Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin < 10 g/dL, platelets < 50,000/μl, White Blood Cell count (WBC) < 2000/μl, serum creatinine >2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
- Family history of diseases leading to QT prolongation or recent treatment with drugs linked to QT prolongation
- Blood transfusion in the last 90 days.
- Consistent with the long half-life of tafenoquine, effective contraception should be continued for 5 half-lives (3 months) after the end of treatment.
- History of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the gametocytocidal and transmission reducing activity of dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Outcome measures will include infectivity to mosquitoes at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density.
Read the detailed description
Full protocol available on request.
- Conditions
- Malaria, Falciparum
- Being tested
- Dihydroartemisinin/Piperaquine, Tafenoquine 100mg [Arakoda]
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin/PiperaquineDrug
Also called Euartesim
Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine (Eurartesim, Sigma Tau), administered according to weight as per the manufacturer instructions.
Tafenoquine 100mg [Arakoda]Drug
Also called Arakoda
Extemporaneous preparation of 1mg/mL Tafenoquine solution, from tablets containing 100mg primaquine (Arakoda, 60degrees pharmaceuticals, DC) dissolved in 100mL water with a non-interacting fruit-flavoured syrup. Solution will be given according to weight as indicated per treatment arm in 5kg bands.
| Study group | Role | What they receive |
|---|---|---|
| Dihydroartemisinin-Piperaquine (DP) | Active comparator | Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a low dose of 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg. Tafenoquine (TQ) on the first date of DP treatment. Receives: Drug: Dihydroartemisinin/Piperaquine |
| DP with 0.415mg/kg Tafenoquine (TQ) | Experimental | Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a single dose of 0.415mg/kg Tafenoquine (TQ) on the first date of DP treatment. Receives: Drug: Dihydroartemisinin/Piperaquine; Drug: Tafenoquine 100mg [Arakoda] |
| DP with 0.83 mg/kg TQ | Experimental | Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a single dose of 0.83mg/kg Tafenoquine (TQ) on the first date of DP treatment. Receives: Drug: Dihydroartemisinin/Piperaquine; Drug: Tafenoquine 100mg [Arakoda] |
| DP with 1.66mg/kg TQ | Experimental | Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and single dose of 1.66mg/kg Tafenoquine (TQ) on the first date of DP treatment. Receives: Drug: Dihydroartemisinin/Piperaquine; Drug: Tafenoquine 100mg [Arakoda] |
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 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 (Days 0 & 7): 7 day span
Secondary outcomes (14)
Change in mosquito infectivity assessed through membrane feeding assays (days 2 and 14)
The proportion of mosquitoes infected, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 2 and 14 post feed, compared to baseline
Measured: 3 days (Days 0, 2, & 14): 14 day span
Mosquito infection density assessed through membrane feeding assays
Mosquito infection density, assessed through membrane feeding and measured as oocyst density in mosquitoes dissected on day 2, 7 and 14 post feed, compared within and between study arms
Measured: 4 days (Days 0, 2, 7 & 14): 14 day span
Mosquito infection prevalence assessed through membrane feeding assays
Mosquito infection prevalence and density, assessed through membrane feeding and measured as oocyst prevalence in mosquitoes dissected on day 2, 7 and 14 post feed, compared within and between study arms
Measured: 4 days (Days 0, 2, 7 & 14): 14 day span
Human infectivity assessed through membrane feeding assays
The proportion of individuals that infect any number of mosquitoes, assessed through membrane feeding and measured as oocyst prevalence/density in mosquitoes dissected on day 2, 7 and 14 post feed, compared within and between study arms
Measured: 4 days (Days 0, 2, 7 & 14): 14 day span
Haemoglobin density
Haemolysis will be monitored by measuring haemoglobin levels (g/dL) on days 0, 1, 2, 7, 14, 21, and 28 post treatment as part of the clinical assessment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Methmoglobin density
Methmoglobin density (g/dL) will be monitored on days 0, 1, 2, 7, 14, 21, and 28 post treatment as part of the clinical assessment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Aspartate transaminase (AST)/alanine transaminase (ALT) ratio
Aspartate transaminase (AST)/alanine transaminase (ALT) ratio will be recorded on days 0, 1, 2, 7, 14, 21, and 28 post treatment as part of the clinical assessment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Blood creatinine level
Blood creatine level will be recorded on days 0, 1, 2, 7, 14, 21, and 28 post treatment as part of the clinical assessment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite density
Asexual/sexual stage parasite density (parasites/microlitre) will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 14, 21, and 28 post treatment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite prevalence
Asexual/sexual stage parasite prevalence will be measured by microscopy and by molecular methods on days 0, 1, 2, 7, 14, 21, and 28 post treatment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite circulation time
Asexual/sexual stage parasite circulation time (days) will be determined from measures of density.
Measured: 28 days
Asexual/sexual stage parasite area under the curve (AUC)
Asexual/sexual stage parasite area under the curve (AUC: Gametocytes per microlitre per day) will be determined from measures of density.
Measured: 28 days
Sexual stage parasite 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, 14, 21 and 28 post treatment.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Incidence of adverse events
Incidence of adverse events will be monitored at each active (day 0,1,2,7,14,21,28) follow up visit. AE's will also be recorded and acted upon if present at any other time during follow up.
Measured: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start29 Oct 2020
- Primary completion2 Dec 2020
- Study completion23 Dec 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alassane Dicko, PhD, MD, Principal investigator, Malaria Research and Training Center, Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609098
- Sponsor's protocol ID
- 21905
- Acronym
- NECTAR2
- Status last verified
- Jun 2022
- First submitted
- 26 Oct 2020
- Last updated
- 9 Jun 2022
- 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, Smit MJ, Sanogo K, Sinaba Y, Niambele SM, Sacko A, Keita S, Dicko OM, Diallo M, Maguiraga SO, Samake S, Attaher O, Lanke K, Ter Heine R, Bradley J, McCall MBB, Issiaka D, Traore SF, Bousema T, Drakeley C, Dicko A. Single low-dose tafenoquine combined with dihydroartemisinin-piperaquine to reduce Plasmodium falciparum transmission in Ouelessebougou, Mali: a phase 2, single-blind, randomised clinical trial. Lancet Microbe. 2022 May;3(5):e336-e347. doi: 10.1016/S2666-5247(21)00356-6. Epub 2022 Mar 23.
PubMed 35544095
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
- ClinicalTrials.gov ID
- NCT04609098
- Acronym / sponsor ID
- NECTAR2 / 21905
- Conditions
- Malaria, Falciparum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 30 Oct 2020 (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 dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Outcome measures will include infectivity to mosquitoes at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density.
Detailed description
Full protocol available 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 |
|---|---|---|
| Dihydroartemisinin-Piperaquine (DP) | Active comparator | Drug: Dihydroartemisinin/PiperaquineSubjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a low dose of 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg. Tafenoquine (TQ) on the first date of DP treatment. |
| DP with 0.415mg/kg Tafenoquine (TQ) | Experimental | Drug: Dihydroartemisinin/Piperaquine, Drug: Tafenoquine 100mg [Arakoda]Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a single dose of 0.415mg/kg Tafenoquine (TQ) on the first date of DP treatment. |
| DP with 0.83 mg/kg TQ | Experimental | Drug: Dihydroartemisinin/Piperaquine, Drug: Tafenoquine 100mg [Arakoda]Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and a single dose of 0.83mg/kg Tafenoquine (TQ) on the first date of DP treatment. |
| DP with 1.66mg/kg TQ | Experimental | Drug: Dihydroartemisinin/Piperaquine, Drug: Tafenoquine 100mg [Arakoda]Subjects will receive Dihydroartemisinin-Piperaquine (DP) once daily for 3 days, and single dose of 1.66mg/kg Tafenoquine (TQ) on the first date of DP treatment. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age ≥ 12 years and ≤ 50 years
- Glucose 6 phosphate dehydrogenase (G6PD) normal status defined by Carestart rapid diagnostic test or the G6PD qualitative test (OSMMR2000)
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells)
- Absence of other non-P. falciparum species on blood film
Key exclusion criteria (20 listed)
- Age < 12 years or > 50 years
- Women who are pregnant or lactating
- Blood thick film negative for sexual stages of malaria
- Detection of a non-P. falciparum species by microscopy
- Previous reaction to study drugs / known allergy to study drugs
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/PiperaquineAlso: EuartesimTablets containing 40 mg dihydroartemisinin/320 mg piperaquine (Eurartesim, Sigma Tau), administered according to weight as per the manufacturer instructions. | Drug | DP with 0.415mg/kg Tafenoquine (TQ), DP with 0.83 mg/kg TQ, DP with 1.66mg/kg TQ, Dihydroartemisinin-Piperaquine (DP) |
| Tafenoquine 100mg [Arakoda]Also: ArakodaExtemporaneous preparation of 1mg/mL Tafenoquine solution, from tablets containing 100mg primaquine (Arakoda, 60degrees pharmaceuticals, DC) dissolved in 100mL water with a non-interacting fruit-flavoured syrup. Solution will be given according to weight as indicated per treatment arm in 5kg bands. | Drug | DP with 0.415mg/kg Tafenoquine (TQ), DP with 0.83 mg/kg TQ, DP with 1.66mg/kg TQ |
Primary outcome
Change in mosquito infectivity assessed through membrane feeding assays (day 7)
Time frame: 2 days (Days 0 & 7): 7 day span
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
14 secondary outcomes
Change in mosquito infectivity assessed through membrane feeding assays (days 2 and 14)
Time frame: 3 days (Days 0, 2, & 14): 14 day span
Mosquito infection density assessed through membrane feeding assays
Time frame: 4 days (Days 0, 2, 7 & 14): 14 day span
Mosquito infection prevalence assessed through membrane feeding assays
Time frame: 4 days (Days 0, 2, 7 & 14): 14 day span
Human infectivity assessed through membrane feeding assays
Time frame: 4 days (Days 0, 2, 7 & 14): 14 day span
Haemoglobin density
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Methmoglobin density
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Aspartate transaminase (AST)/alanine transaminase (ALT) ratio
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Blood creatinine level
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite density
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite prevalence
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Asexual/sexual stage parasite circulation time
Time frame: 28 days
Asexual/sexual stage parasite area under the curve (AUC)
Time frame: 28 days
Sexual stage parasite sex ratio
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
Incidence of adverse events
Time frame: 7 days (Days 0, 1, 2, 7, 14, 21 & 28): 28 day span
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 9 Jun 2022.
- Derived from this study: PubMed 35544095Stone W, Mahamar A, Smit MJ, Sanogo K, Sinaba Y, Niambele SM, Sacko A, Keita S, Dicko OM, Diallo M, Maguiraga SO, Samake S, Attaher O, Lanke K, Ter Heine R, Bradley J, McCall MBB, Issiaka D, Traore SF, Bousema T, Drakeley C, Dicko A. Single low-dose tafenoquine combined with dihydroartemisinin-piperaquine to reduce Plasmodium falciparum transmission in Ouelessebougou, Mali: a phase 2, single-blind, randomised clinical trial. Lancet Microbe. 2022 May;3(5):e336-e347. doi: 10.1016/S2666-5247(21)00356-6. Epub 2022 Mar 23.
- Trial reportLink provided by the sponsor.
- 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.
Alassane Dicko, PhD, MD principal investigator
Malaria Research and Training Center, Bamako, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dihydroartemisinin/Piperaquine and Tafenoquine 100mg [Arakoda] in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Mali.
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 11 inclusion and 20 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 9 Jun 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 Mali. 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 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?
Change in mosquito infectivity assessed through membrane feeding assays (day 7) (time frame: 2 days (Days 0 & 7): 7 day span). 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 NCT04609098, 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 9 Jun 2022.