Malaria, FalciparumPhase 4NCT02434952
Safety and Tolerability of Low Dose Primaquine
A Phase 4 study testing Dihydroartemisinin piperaquine (DHA PP) and Primaquine in people with Malaria, Falciparum and G6PD Deficiency, run by Malaria Consortium at 1 site in Cambodia.
Trial summary
In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malaria, Falciparum, G6PD Deficiency
- What is being tested?
- Dihydroartemisinin piperaquine (DHA PP) and Primaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteCambodia
- Study dates
- Oct 2014to Jul 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 1 year
- Presentation with a confirmed fever (≥ 38⁰C axilla or ≥ 37.5⁰C aural) or history of fever in previous 48 hours +/- other clinical features of uncomplicated malaria
- Plasmodium falciparum monoinfection ≥ 1 asexual form / 500 white blood cells
- Informed consent (written/verbal) provided by patient or relative/legal guardian
- Signed Assent form for children aged 12 to < 18 years
Who cannot join
- Clinical signs of severe malaria or danger signs
- Pregnant or breast feeding
- Unable or unwilling to take a pregnancy test (for women of child-bearing age)
- Women intending to become pregnant in the next 3 months
- Allergic to primaquine or DHA PP
- Patients taking drugs known to cause acute intravascular haemolytic anaemia (AIHA) in G6PD deficiency e.g. dapsone, nalidixic acid
- Patients on treatment for a significant illness e.g. HIV, tuberculosis (TB) treatment, steroids
- On drugs that could interfere with anti-malarial pharmacokinetics like antiretrovirals, cimetidine, ketoconazole, antiepileptic drugs, rifampicin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Tolerability and Safety of Low Dose Primaquine for Transmission Blocking in Symptomatic Falciparum Infected Cambodians
In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop in the mosquito so it will not be able to inject malaria back into people when it bites. The drug the investigators will use is called primaquine.
Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.
- Conditions
- Malaria, Falciparum, G6PD Deficiency
- Being tested
- Dihydroartemisinin piperaquine (DHA PP), Primaquine
- Keywords
- Malaria, Falciparum, G6PD deficiency, Primaquine, Asia
- Medical subject headings
- Malaria, Falciparum, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin piperaquine (DHA PP)Drug
Also called Duo-Cotecxin, Eurartesim
PrimaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| DHA PP plus primaquine, G6PD deficiency | Experimental | Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP.
Target dose of 0.25mg/kg primaquine given orally with first dose only of DHA PP, dosing by weight for children <18 years and standard 15mg primaquine dose for all adults ≥18 years. Small children (<25kg) will receive a primaquine suspension, adults receive 7.5mg or 15mg primaquine tablets. Receives: Drug: Dihydroartemisinin piperaquine (DHA PP); Drug: Primaquine |
| DHA PP plus primaquine, G6PD normal | Active comparator | Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP.
Target dose of 0.25mg/kg primaquine given orally with first dose only of DHA PP, dosing by weight for children <18 years and standard 15mg primaquine dose for all adults ≥18 years. Small children (<25kg) will receive a primaquine suspension, adults receive 7.5mg or 15mg primaquine tablets. Receives: Drug: Dihydroartemisinin piperaquine (DHA PP); Drug: Primaquine |
| DHA PP alone, G6PD deficiency | Active comparator | Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. Receives: Drug: Dihydroartemisinin piperaquine (DHA PP) |
| DHA PP alone, G6PD normal | Active comparator | Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. Receives: Drug: Dihydroartemisinin piperaquine (DHA PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration
Compare haemoglobin concentrations in g/dL between the G6PD deficient arm given DHA PP plus primaquine, and the G6PD normal arm receiving the same regimen
Measured: Day 7
Secondary outcomes (19)
Determine G6PD enzyme activity
Quantitative G6PD testing among all participants using the G6PD enzyme assay from Trinity Biologicals, USA, yielding G6PD enzyme results in U/g Hb.
Measured: Day 0
Assess usefulness of field adapted WHO haemoglobin colour card vs. Hemocue
Comparison of quantitative (HemoCue, g/dL HB) and qualitative (WHO haemolglobin colour card) estimates of haemoglobin concentration
Measured: Day 0
Assess usefulness of rapid test for G6PDd in predicting acute intravascular haemolysis
Comparison of rapid G6PD test (AccessBio, USA) qualitative result against quantitative G6PD assay to determine predictive value for clinically significant haemolysis
Measured: Day 0
Proportion patients with ≥25% change in haemoglobin as a marker of intravascular haemolysis
Comparing across all 4 arms: proportion of all patients with fractional change in haemoglobin ≥25% from day 0 to day 7
Measured: Change from Day 0 to Day 7
Plasma haemoglobin concentration as a marker of intravascular haemolysis
Comparing across all 4 arms: plasma haemoglobin concentration at day 7
Measured: Day 7
Urine colour change as a marker of intravascular haemolysis
Change in urine colour grade from day 0 to day 7 (Hillmen, Hall et al. 2004)
Measured: Change from Day 0 to Day 7
Fractional change in haemoglobin as a marker of intravascular haemolysis
Comparing across all 4 arms: fractional change in haemoglobin on day 7 vs. day 0
Measured: Change from Day 0 to Day 7
Clearance rate of primaquine
Primaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Half life of primaquine
Primaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Primaquine volume of distribution
Primaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Clearance rate of piperaquine
Piperaquine elimination clearance rate, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Half life of piperaquine
Piperaquine terminal elimination half life, modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Piperaquine volume of distribution
Piperaquine apparent volume of distribution (Vd), modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Peak plasma concentration (Cmax) of primaquine
Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Peak plasma concentration (Cmax) of piperaquine
Cmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Time to primquine peak plasma concentration (Tmax)
Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Time to piperaquine peak plasma concentration (Tmax)
Tmax taken directly from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Area under the plasma concentration versus time curve - primaquine
Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP + PQ
Measured: Day 0-7
Area under the plasma concentration versus time curve - piperaquine
Modelled from population pharmacokinetic data from all patients receiving at least one dose of DHA PP +/- PQ
Measured: Day 0-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Institute Pasteur, Cambodia, World Health Organization, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Dysoley Lek, MD, Principal investigator, National Centre for Parasitology, Entomology and Malaria Control, Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434952
- Sponsor's protocol ID
- 015NECHR
- Status last verified
- Aug 2016
- First submitted
- 11 Sep 2014
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vantaux A, Kim S, Piv E, Chy S, Berne L, Khim N, Lek D, Siv S, Mukaka M, Taylor WR, Menard D. Significant Efficacy of a Single Low Dose of Primaquine Compared to Stand-Alone Artemisinin Combination Therapy in Reducing Gametocyte Carriage in Cambodian Patients with Uncomplicated Multidrug-Resistant Plasmodium falciparum Malaria. Antimicrob Agents Chemother. 2020 May 21;64(6):e02108-19. doi: 10.1128/AAC.02108-19. Print 2020 May 21.
PubMed 32179526Dysoley L, Kim S, Lopes S, Khim N, Bjorges S, Top S, Huch C, Rekol H, Westercamp N, Fukuda MM, Hwang J, Roca-Feltrer A, Mukaka M, Menard D, Taylor WR. The tolerability of single low dose primaquine in glucose-6-phosphate deficient and normal falciparum-infected Cambodians. BMC Infect Dis. 2019 Mar 12;19(1):250. doi: 10.1186/s12879-019-3862-1.
PubMed 30871496
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tolerability and Safety of Low Dose Primaquine for Transmission Blocking in Symptomatic Falciparum Infected Cambodians
- ClinicalTrials.gov ID
- NCT02434952
- Acronym / sponsor ID
- 015NECHR
- Conditions
- Malaria, Falciparum, G6PD Deficiency
- Keywords
- Malaria, Falciparum, G6PD deficiency, Primaquine, Asia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Malaria ConsortiumUniversity, hospital or other
- Collaborators
- National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Institute Pasteur, Cambodia, World Health Organization, Centers for Disease Control and Prevention
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- First posted
- 6 May 2015 (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.
In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop in the mosquito so it will not be able to inject malaria back into people when it bites. The drug the investigators will use is called primaquine.
Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DHA PP plus primaquine, G6PD deficiency | Experimental | Drug: Dihydroartemisinin piperaquine (DHA PP), Drug: PrimaquineStandard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. Target dose of 0.25mg/kg primaquine given orally with first dose only of DHA PP, dosing by weight for children <18 years and standard 15mg primaquine dose for all adults ≥18 years. Small children (<25kg) will receive a primaquine suspension, adults receive 7.5mg or 15mg primaquine tablets. |
| DHA PP plus primaquine, G6PD normal | Active comparator | Drug: Dihydroartemisinin piperaquine (DHA PP), Drug: PrimaquineStandard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. Target dose of 0.25mg/kg primaquine given orally with first dose only of DHA PP, dosing by weight for children <18 years and standard 15mg primaquine dose for all adults ≥18 years. Small children (<25kg) will receive a primaquine suspension, adults receive 7.5mg or 15mg primaquine tablets. |
| DHA PP alone, G6PD deficiency | Active comparator | Drug: Dihydroartemisinin piperaquine (DHA PP)Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. |
| DHA PP alone, G6PD normal | Active comparator | Drug: Dihydroartemisinin piperaquine (DHA PP)Standard Dihydroartemisinin piperaquine (DHA PP) dosing according to national guidelines, oral administration of one dose per day for three consecutive days. Target dosing is 2-4 mg/kg for DHA and 20 mg/kg for PP. Children (<30kg) will receive tablets of 20mg DHA and 160mg PP, while adults will receive tablets of 40mg DHA and 320mg PP. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 1 year
- Presentation with a confirmed fever (≥ 38⁰C axilla or ≥ 37.5⁰C aural) or history of fever in previous 48 hours +/- other clinical features of uncomplicated malaria
- Plasmodium falciparum monoinfection ≥ 1 asexual form / 500 white blood cells
- Informed consent (written/verbal) provided by patient or relative/legal guardian
- Signed Assent form for children aged 12 to < 18 years
Key exclusion criteria (8 listed)
- Clinical signs of severe malaria or danger signs
- Pregnant or breast feeding
- Unable or unwilling to take a pregnancy test (for women of child-bearing age)
- Women intending to become pregnant in the next 3 months
- Allergic to primaquine or DHA PP
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 (DHA PP)Also: Duo-Cotecxin, Eurartesim | Drug | DHA PP alone, G6PD deficiency, DHA PP alone, G6PD normal, DHA PP plus primaquine, G6PD deficiency, DHA PP plus primaquine, G6PD normal |
| Primaquine | Drug | DHA PP plus primaquine, G6PD deficiency, DHA PP plus primaquine, G6PD normal |
Primary outcome
Haemoglobin concentration
Time frame: Day 7
Compare haemoglobin concentrations in g/dL between the G6PD deficient arm given DHA PP plus primaquine, and the G6PD normal arm receiving the same regimen
19 secondary outcomes
Determine G6PD enzyme activity
Time frame: Day 0
Assess usefulness of field adapted WHO haemoglobin colour card vs. Hemocue
Time frame: Day 0
Assess usefulness of rapid test for G6PDd in predicting acute intravascular haemolysis
Time frame: Day 0
Proportion patients with ≥25% change in haemoglobin as a marker of intravascular haemolysis
Time frame: Change from Day 0 to Day 7
Plasma haemoglobin concentration as a marker of intravascular haemolysis
Time frame: Day 7
Urine colour change as a marker of intravascular haemolysis
Time frame: Change from Day 0 to Day 7
Fractional change in haemoglobin as a marker of intravascular haemolysis
Time frame: Change from Day 0 to Day 7
Clearance rate of primaquine
Time frame: Day 0-7
Half life of primaquine
Time frame: Day 0-7
Primaquine volume of distribution
Time frame: Day 0-7
Clearance rate of piperaquine
Time frame: Day 0-28
Half life of piperaquine
Time frame: Day 0-28
Piperaquine volume of distribution
Time frame: Day 0-28
Peak plasma concentration (Cmax) of primaquine
Time frame: Day 0-7
Peak plasma concentration (Cmax) of piperaquine
Time frame: Day 0-28
Time to primquine peak plasma concentration (Tmax)
Time frame: Day 0-7
Time to piperaquine peak plasma concentration (Tmax)
Time frame: Day 0-28
Area under the plasma concentration versus time curve - primaquine
Time frame: Day 0-7
Area under the plasma concentration versus time curve - piperaquine
Time frame: Day 0-28
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 23 Aug 2016.
- Derived from this study: PubMed 32179526Vantaux A, Kim S, Piv E, Chy S, Berne L, Khim N, Lek D, Siv S, Mukaka M, Taylor WR, Menard D. Significant Efficacy of a Single Low Dose of Primaquine Compared to Stand-Alone Artemisinin Combination Therapy in Reducing Gametocyte Carriage in Cambodian Patients with Uncomplicated Multidrug-Resistant Plasmodium falciparum Malaria. Antimicrob Agents Chemother. 2020 May 21;64(6):e02108-19. doi: 10.1128/AAC.02108-19. Print 2020 May 21.
- Derived from this study: PubMed 30871496Dysoley L, Kim S, Lopes S, Khim N, Bjorges S, Top S, Huch C, Rekol H, Westercamp N, Fukuda MM, Hwang J, Roca-Feltrer A, Mukaka M, Menard D, Taylor WR. The tolerability of single low dose primaquine in glucose-6-phosphate deficient and normal falciparum-infected Cambodians. BMC Infect Dis. 2019 Mar 12;19(1):250. doi: 10.1186/s12879-019-3862-1.
- Malaria ConsortiumLink provided by the sponsor.
- National Centre for Parasitology, Entomology and Malaria Control Program, CambodiaLink provided by the sponsor.
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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.
Dysoley Lek, MD principal investigator
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
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 Dihydroartemisinin piperaquine (DHA PP) and Primaquine in people with Malaria, Falciparum and G6PD Deficiency, run by Malaria Consortium at 1 site in Cambodia.
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 5 inclusion and 8 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 23 Aug 2016. 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 Cambodia. 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?
Haemoglobin concentration (time frame: Day 7). 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 NCT02434952, 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 23 Aug 2016.