MalariaPhase 2/3NCT02174900
Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)
A Phase 2/3 study testing Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine, Artemether-Lumefantrine (AL) combination and Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
Trial summary
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine, Artemether-Lumefantrine (AL) combination and Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Oct 2014to Dec 2015
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gender
- Age ≥18 years and ≤45 years
- BMI ≥16
- P. falciparum parasitaemia at any density
- G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50)
- G6PD normal activity by Beutler Fluorescent Spot test for control groups (N=20)
- Informed consent by participant
Who cannot join
- Enrolled in another clinical trial
- Fever >37.5°C (tympanic) or history of fever in the last 24 hours
- Evidence of severe illness / danger signs or active infection other than malaria
- Known allergy to study medications
- Hb <11 g/dL
- Antimalarials taken within the last 2 weeks
Show all 10Show fewer
- PQ taken within the last 4 weeks and blood transfusion within the last 90 days
- Non-falciparum malaria co-infection
- Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, , nalidixic acid, ciprofloxacin, , methylene blue, toluidine blue phenazopyridine and co-trimoxazole.
- History of severe chronic illness
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou
About this study
Official title: Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
- Conditions
- Malaria
- Being tested
- Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine, Artemether-Lumefantrine (AL) combination, Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
- Keywords
- G6PD deficiency, safety, transmission
- Medical subject headings
- Malaria, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquineDrug
Artemether-Lumefantrine (AL) combinationDrug
Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| G6PD deficient 0.25 mg/kg PQ + AL | Experimental | G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine Receives: Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
| G6PD deficient receiving AL only | Active comparator | G6PD deficient males receiving Artemether-Lumefantrine (AL) combination Receives: Drug: Artemether-Lumefantrine (AL) combination |
| G6PD normal 0.25 mg/kg PQ + AL | Active comparator | G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine Receives: Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
| G6PD normal 0.4 mg/kg PQ + AL | Active comparator | G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine Receives: Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
| G6PD-deficient 0.4 mg/kg PQ + AL | Experimental | G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine Receives: Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration relative to baseline value
Haemoglobin concentration relative to baseline value
Measured: 28 days
Secondary outcomes (1)
Gametocyte clearance time
Gametocyte clearance time
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre national de recherche et de formation sur le paludisme, University Medical Center Nijmegen
- Responsible party
- Sponsor
- Investigators
- Teun Bousema, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174900
- Sponsor's protocol ID
- SAFEPRIM
- Status last verified
- Jan 2016
- First submitted
- 11 Jun 2014
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
PubMed 29324864
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)
- ClinicalTrials.gov ID
- NCT02174900
- Acronym / sponsor ID
- SAFEPRIM
- Conditions
- Malaria
- Keywords
- G6PD deficiency, safety, transmission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre national de recherche et de formation sur le paludisme, University Medical Center Nijmegen
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jun 2014 (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.
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| G6PD deficient 0.25 mg/kg PQ + AL | Experimental | Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquineG6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
| G6PD deficient receiving AL only | Active comparator | Drug: Artemether-Lumefantrine (AL) combinationG6PD deficient males receiving Artemether-Lumefantrine (AL) combination |
| G6PD normal 0.25 mg/kg PQ + AL | Active comparator | Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquineG6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine |
| G6PD normal 0.4 mg/kg PQ + AL | Active comparator | Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquineG6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
| G6PD-deficient 0.4 mg/kg PQ + AL | Experimental | Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquineG6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male gender
- Age ≥18 years and ≤45 years
- BMI ≥16
- P. falciparum parasitaemia at any density
- G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50)
Key exclusion criteria (10 listed)
- Enrolled in another clinical trial
- Fever >37.5°C (tympanic) or history of fever in the last 24 hours
- Evidence of severe illness / danger signs or active infection other than malaria
- Known allergy to study medications
- Hb <11 g/dL
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 |
|---|---|---|
| Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine | Drug | G6PD deficient 0.25 mg/kg PQ + AL, G6PD normal 0.25 mg/kg PQ + AL |
| Artemether-Lumefantrine (AL) combination | Drug | G6PD deficient receiving AL only |
| Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine | Drug | G6PD normal 0.4 mg/kg PQ + AL, G6PD-deficient 0.4 mg/kg PQ + AL |
Primary outcome
Haemoglobin concentration relative to baseline value
Time frame: 28 days
Haemoglobin concentration relative to baseline value
1 secondary outcome
Gametocyte clearance time
Time frame: 14 days
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 1 Feb 2016.
- Derived from this study: PubMed 29324864Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
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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.
Teun Bousema, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine, Artemether-Lumefantrine (AL) combination and Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
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 7 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 1 Feb 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 Burkina Faso. 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?
Haemoglobin concentration relative to baseline value (time frame: 28 days). 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 NCT02174900, 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 1 Feb 2016.