MalariaPhase 2NCT01743820
Phase2a Primaquine Dose Escalation Study
A Phase 2 study testing dihydroartemisinin-piperaquine, 0.125 mg/kg Primaquine and 0.5 mg/kg Primaquine in people with Malaria, run by University of California, San Francisco at 1 site in Mali.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- dihydroartemisinin-piperaquine, 0.125 mg/kg Primaquine and 0.5 mg/kg Primaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteMali
- Study dates
- Sep 2013to Dec 2014
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age >= 18 years and < 50 years
- Malaria blood thick film positive
- Presence of gametocytes on thick blood film
- Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
- No allergies to study drugs
Show all 9Show fewer
- Hemoglobin >= 8 g/dl
- No evidence of severe or chronic disease
- Written, informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
- Conditions
- Malaria
- Being tested
- dihydroartemisinin-piperaquine, 0.125 mg/kg Primaquine, 0.5 mg/kg Primaquine, 0.25 mg/kg Primaquine, 0.0625 mg/kg Primaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisinin-piperaquineDrug
0.125 mg/kg PrimaquineDrug
0.5 mg/kg PrimaquineDrug
0.25 mg/kg PrimaquineDrug
0.0625 mg/kg PrimaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| dihydroartemisinin-piperaquine only | Active comparator | dihydroartemisinin -piperaquine (DP) only Receives: Drug: dihydroartemisinin-piperaquine |
| DP and 0.125 mg/kg primaquine | Experimental | DP and single dose oral 0.125 mg/kg primaquine Receives: Drug: dihydroartemisinin-piperaquine; Drug: 0.125 mg/kg Primaquine |
| DP and 0.5 mg/kg primaquine | Experimental | DP and single dose oral 0.5 mg/kg primaquine Receives: Drug: dihydroartemisinin-piperaquine; Drug: 0.5 mg/kg Primaquine |
| DP and 0.25 mg/kg primaquine | Experimental | DP and a single dose oral 0.25 mg/kg primaquine Receives: Drug: dihydroartemisinin-piperaquine; Drug: 0.25 mg/kg Primaquine |
| DP and 0.0625 mg/kg primaquine | Experimental | DP and a single dose oral 0.0625 mg/kg primaquine Receives: Drug: dihydroartemisinin-piperaquine; Drug: 0.0625 mg/kg Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mosquito infectivity assessed through membrane feeding
Baseline, Days 1, 2, 7
Measured: 7 days
Secondary outcomes (4)
gametocyte prevalence and density
Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
Measured: 28 days
primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite
Hours 1, 2, 3, 4, 6, 8, 12, 24
Measured: 24 hours
asexual parasite prevalence and density
Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
Measured: 28 days
safety measurements including hemoglobin and signs of hemolysis
Baseline, Days 1, 2, 3, 7, 14, 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Shoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Bill and Melinda Gates Foundation, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Roland Gosling, MD, PhD, Principal investigator, University of California, San FranciscoAlassane Dicko, MD, Principal investigator, Malaria Research and Training CentreFrançois Nosten, MD, Principal investigator, Shoklo Malaria Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743820
- Sponsor's protocol ID
- MEG001
- Status last verified
- Jan 2015
- First submitted
- 26 Nov 2012
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26.
PubMed 21951597Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.
PubMed 17254503WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.
WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization
El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.
PubMed 18074034Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1.
PubMed 20194698Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.
PubMed 26906747
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia
- ClinicalTrials.gov ID
- NCT01743820
- Acronym / sponsor ID
- MEG001
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Shoklo Malaria Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Bill and Melinda Gates Foundation, Wellcome Trust
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2012 (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 safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dihydroartemisinin-piperaquine only | Active comparator | Drug: dihydroartemisinin-piperaquinedihydroartemisinin -piperaquine (DP) only |
| DP and 0.125 mg/kg primaquine | Experimental | Drug: dihydroartemisinin-piperaquine, Drug: 0.125 mg/kg PrimaquineDP and single dose oral 0.125 mg/kg primaquine |
| DP and 0.5 mg/kg primaquine | Experimental | Drug: dihydroartemisinin-piperaquine, Drug: 0.5 mg/kg PrimaquineDP and single dose oral 0.5 mg/kg primaquine |
| DP and 0.25 mg/kg primaquine | Experimental | Drug: dihydroartemisinin-piperaquine, Drug: 0.25 mg/kg PrimaquineDP and a single dose oral 0.25 mg/kg primaquine |
| DP and 0.0625 mg/kg primaquine | Experimental | Drug: dihydroartemisinin-piperaquine, Drug: 0.0625 mg/kg PrimaquineDP and a single dose oral 0.0625 mg/kg primaquine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male
- Age >= 18 years and < 50 years
- Malaria blood thick film positive
- Presence of gametocytes on thick blood film
- Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
Key exclusion criteria (0 listed)
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 | Drug | DP and 0.0625 mg/kg primaquine, DP and 0.125 mg/kg primaquine, DP and 0.25 mg/kg primaquine, DP and 0.5 mg/kg primaquine, dihydroartemisinin-piperaquine only |
| 0.125 mg/kg Primaquine | Drug | DP and 0.125 mg/kg primaquine |
| 0.5 mg/kg Primaquine | Drug | DP and 0.5 mg/kg primaquine |
| 0.25 mg/kg Primaquine | Drug | DP and 0.25 mg/kg primaquine |
| 0.0625 mg/kg Primaquine | Drug | DP and 0.0625 mg/kg primaquine |
Primary outcome
mosquito infectivity assessed through membrane feeding
Time frame: 7 days
Baseline, Days 1, 2, 7
4 secondary outcomes
gametocyte prevalence and density
Time frame: 28 days
primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite
Time frame: 24 hours
asexual parasite prevalence and density
Time frame: 28 days
safety measurements including hemoglobin and signs of hemolysis
Time frame: 28 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 19 Jan 2015.
- Background: PubMed 21951597Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26.
- Background: PubMed 17254503Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.
- BackgroundWHO (2011) World Malaria Report 2011. Geneva: World Health Organization.
- BackgroundWHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization
- Background: PubMed 18074034El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.
- Background: PubMed 20194698Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1.
- Derived from this study: PubMed 26906747Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.
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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.
Roland Gosling, MD, PhD principal investigator
University of California, San Francisco
Alassane Dicko, MD principal investigator
Malaria Research and Training Centre
François Nosten, MD principal investigator
Shoklo Malaria Research Unit
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, 0.125 mg/kg Primaquine and 0.5 mg/kg Primaquine in people with Malaria, run by University of California, San Francisco 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 9 inclusion and 0 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 19 Jan 2015. 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?
mosquito infectivity assessed through membrane feeding (time frame: 7 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 NCT01743820, which also lists 7 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 19 Jan 2015.