Low Dose Primaquine for Clearance of Gametocytes

Status Completed

Clinical Trial Summary

Primaquine (PQ) is currently the only available drug that can clear mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisinin-combination therapy. However, there are safety concerns about the use of PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD deficient individuals; this side-effect is dose dependent. There are indications that a lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for gametocyte clearance is currently unknown. Recently, the World Health Organization changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and what the lowest efficacious dose is.

In the current study we aim to identify the lowest efficacious dose of PQ in individuals with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will be randomized to treatment with artemether-lumefantrine alone or in combination with low doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up, measured by molecular methods. For a subset of participants with patent gametocytes, primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01935882
Study type	Interventional
Source	London School of Hygiene and Tropical Medicine
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2013
Completion date	July 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04601714` - Baseline Cohort Malaria Morbidity Study
Withdrawn	`NCT04020653` - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria	Phase 2
Terminated	`NCT04368910` - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria	Phase 3
Completed	`NCT03641339` - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans	N/A
Completed	`NCT02544048` - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed	`NCT00527163` - Role of Nitric Oxide in Malaria
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Active, not recruiting	`NCT04704674` - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
Completed	`NCT03276962` - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age	Phase 2
Completed	`NCT04966871` - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults	Phase 1
Completed	`NCT00289185` - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants	Phase 2
Recruiting	`NCT03937817` - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting	`NCT06153862` - Africa Ready Malaria Screening	N/A
Completed	`NCT04545905` - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting	`NCT06278181` - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Completed	`NCT02793622` - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants	Phase 3
Withdrawn	`NCT02793388` - A Trial on Supervised Primaquine Use in Ethiopia	Phase 4
Completed	`NCT02909712` - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania	Phase 2
Withdrawn	`NCT02793414` - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed	`NCT02536222` - Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Low Dose Primaquine for Clearance of Gametocytes — LOPRIM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms