Trial · Interventional

CompletedPhase 2Registry data

Phase 2 Efficacy Study of Primaquine and Methylene Blue

NCTNCT02831023Other idUCSF CHR # 15-16839

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 80 participants (actual)
Sponsor: University of California, San Francisco · Other
Design: Randomized · Single masking
Countries: 1 country
Mali
Start: Jul 2016
Primary completion: Jan 2017
Completion: Jan 2017
First posted: 13 Jul 2016 (estimated)
Last update posted: 11 Jan 2017 (estimated)
Conditions: Malaria

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018

Ph 2
Phase 2 Efficacy Study of Primaquine and Methylene Blue
NCT02831023
Jul 2016 to Jan 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.

Interventions

Sulphadoxine-pyrimethamineDrug
0.25 mg/kg primaquineDrug
Dihydroartemisinin-piperaquineDrug
Methylene blueDrug
AmodiaquineDrug

Arms4

Active comparator
SP-AQ only
Subjects will receive sulphadoxine-pyrimethamine (SP) as single dose and administered in combination with amodiaquine (AQ), which will be given once daily for 3 days.
Experimental
SP-AQ plus PQ
Participants in this arm will receive SP-AQ in combination with a single low dose of primaquine at the World Health Organization (WHO) recommended dose of 0.25 mg/kg.
Active comparator
DP only
Participants in this arm will be treated with dihydroartemisinin-piperaquine (DP), which will be administered once a day for three days.
Experimental
DP plus MB
Study participants in this arm will receive DP as described above combined with once-daily methylene blue (MB) for 3 days, at 15 mg/kg/day (45 mg/kg total over 3 days).

Primary outcomes1

Outcomes the sponsor listed as primary.

Mosquito infectivity assessed through membrane feeding assays
Time frame · 7 day
Registry description
Infectivity will be measured by oocyst prevalence in dissected mosquitoes. Primary endpoint will be a comparison between mean of pretreatment infectivity (day 0) and infectivity at days 2 and 7 post first dose.

Secondary outcomes(16)

Gametocyte prevalence, density, and sex ratio measured microscopically and by molecular methods.
Time frame · 42 days
Registry description
Outcome measured at baseline and days 1, 2, 3, 7, 14, 28, and 42 post first dose.
Asexual parasite prevalence and density
Time frame · 42 days
Registry description
Asexual parasitemia will be evaluated by blood smear microscopy and confirmed by more sensitive, molecular methods. Outcome measured at baseline and days 1, 2, 3, 7, 14, 28, and 42 post first dose.
Safety measurements including hemoglobin and signs of hemolysis
Time frame · 42 days
Registry description
The major safety endpoint is hemolysis. For this reason, hemoglobin and methemoglobin values will be measured before treatment, at baseline and on days 1, 2, 3, 7, 14, 28, and 42 post first dose. In addition, clinical review (including additional signs of hemolysis) will be assessed based on active and passive follow-up.
Peak plasma concentration (Cmax) of primaquine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Area under the concentration curve (AUC) of primaquine.
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Elimination half life (t1/2) of primaquine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Peak plasma concentration (Cmax) of methylene blue
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Area under the concentration curve (AUC) of methylene blue
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Elimination half life (t1/2) of methylene blue
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Peak plasma concentration (Cmax) of sulphadoxine-pyrimethamine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Area under the concentration curve (AUC) of sulphadoxine-pyrimethamine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Elimination half-life (t1/2) of sulphadoxine-pyrimethamine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Peak plasma concentration (Cmax) of dihydroartemisinin-piperaquine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Area under the concentration curve (AUC) of dihydroartemisinin-piperaquine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Elimination half-life (t1/2) of dihydroartemisinin-piperaquine
Time frame · 24 hours
Registry description
Outcome measured at hours 1, 2, 4, 6, 8, and 24 post first dose.
Identification of cytochrome P450 (CYP) 2D6 and G6PD polymorphisms
Time frame · 1 hour
Registry description
CYP2D6 and G6PD genotyping will be performed using Thermo Fisher Scientific OpenArray Technology and Copy Number Variation (CNV) assays on the QuantStudio™ 12K Flex Real-Time PCR System.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

3 results

Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial.

Dicko et al. 2018The Lancet. Infectious diseasescited by 88

PMID 29422384PMC5968371DOI 10.1016/s1473-3099(18)30044-6PUB-29422384

CC BY3 results

Download PDF See results (3)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 5 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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