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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02831023 |
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Date of registration:
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06/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 2 Efficacy Study of Primaquine and Methylene Blue
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Scientific title:
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Efficacy, Safety, and Pharmacokinetics of Sulphadoxine-pyrimethamine-amodiaquine (SP-AQ), SP-AQ Plus Primaquine, Dihydroartemisinin-piperaquine (DP), DP Plus Methylene Blue for Preventing Transmission of P. Falciparum Gametocytes in Mali |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02831023 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Mali
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Contacts
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Name:
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Roland Gosling, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Name:
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Teun Bousema, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University |
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Name:
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Alassane Dicko, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Malaria Research and Training Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Glucose-6-phosphate dehydrogenase (G6PD) normal defined by CareStart™ G6PD rapid
diagnostic test (RDT) or the OSMMR2000 G6PD semi-qualitative test
- Absence of symptomatic falciparum malaria, defined by fever upon enrollment
- Presence of P. falciparum gametocytes on thick blood film at a density >30
gametocytes/µL (i.e. =2 gametocytes recorded in the thick film against 500 white blood
cells)
- No allergies to study drugs
- No self-reported 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 severe or chronic disease
- Written, informed consent
Exclusion Criteria:
- Age < 5 years or > 50 years
- Female gender
- Blood thick film negative for sexual stages of malaria
- Previous reaction to study drugs/known allergy to study drugs
- Signs of severe malaria, including hyperparasitemia, defined as asexual parasitemia >
100,000 parasites / µL)
- Signs of acute or chronic illness, including hepatitis
- Use of other medications (with the exception of paracetamol and/or aspirin)
- Consent not given
Age minimum:
5 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: 0.25 mg/kg primaquine
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Drug: Methylene blue
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Drug: Amodiaquine
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Drug: Sulphadoxine-pyrimethamine
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Drug: Dihydroartemisinin-piperaquine
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Primary Outcome(s)
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Mosquito infectivity assessed through membrane feeding assays
[Time Frame: 7 day]
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Secondary Outcome(s)
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Area under the concentration curve (AUC) of dihydroartemisinin-piperaquine
[Time Frame: 24 hours]
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Identification of cytochrome P450 (CYP) 2D6 and G6PD polymorphisms
[Time Frame: 1 hour]
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Elimination half life (t1/2) of primaquine
[Time Frame: 24 hours]
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Area under the concentration curve (AUC) of methylene blue
[Time Frame: 24 hours]
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Elimination half-life (t1/2) of dihydroartemisinin-piperaquine
[Time Frame: 24 hours]
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Elimination half-life (t1/2) of sulphadoxine-pyrimethamine
[Time Frame: 24 hours]
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Peak plasma concentration (Cmax) of primaquine
[Time Frame: 24 hours]
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Area under the concentration curve (AUC) of primaquine.
[Time Frame: 24 hours]
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Gametocyte prevalence, density, and sex ratio measured microscopically and by molecular methods.
[Time Frame: 42 days]
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Peak plasma concentration (Cmax) of methylene blue
[Time Frame: 24 hours]
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Area under the concentration curve (AUC) of sulphadoxine-pyrimethamine
[Time Frame: 24 hours]
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Elimination half life (t1/2) of methylene blue
[Time Frame: 24 hours]
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Asexual parasite prevalence and density
[Time Frame: 42 days]
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Peak plasma concentration (Cmax) of dihydroartemisinin-piperaquine
[Time Frame: 24 hours]
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Safety measurements including hemoglobin and signs of hemolysis
[Time Frame: 42 days]
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Peak plasma concentration (Cmax) of sulphadoxine-pyrimethamine
[Time Frame: 24 hours]
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Secondary ID(s)
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UCSF CHR # 15-16839
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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