Clinical Trials Logo

Clinical Trial Summary

Primaquine (PQ) is currently the only available drug that can clear the mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisinin-combination therapy. A major caveat to the use of primaquine in mass adminsitrations for the reduction of malaria transmission is that metabolism of the drug in individuals with glucose-6 phosphate dehydrogenase (G6PD) deficiency can lead to transient haemolysis. The haemolytic side effect of PQ is dose-related. Haemolysis is more commonly observed after prolonged PQ treatment but has also been observed in African populations following a single dose of PQ. This haemolysis was self-limiting, largely restricted to G6PD deficient individuals and did not lead to clinical symptoms. Nevertheless, any drug-induced haemolysis is reason for concern and the World Health Organization has therefore reduced the recommended dose of single low dose primaquine from 0.75mg/kg to 0.25mg/kg. This dosage is deemed safe without prior G6PD or Hb screening. However, there is limited direct evidence on the extent to which this dosage of PQ prevents malaria transmission to mosquitoes.

In the current study, the investigators will assess the efficacy of DP in combination with low-dose PQ to prevent onward malaria transmission. The investigators will perform the investigators study in individuals aged 5-15 years who are carry microscopically detectable densities of P. falciparum gametocytes. This age group is chosen because asexual parasite carriage and gametocyte carriage are common in this age group. All enrolled individuals will receive a full three-day course of DP, and will be randomized to receive a dose of primaquine or placebo with their third dose. Efficacy will be determined based on gametocyte carriage during follow-up, measured by molecular methods. For all individuals, the effect of treatment on infectivity to mosquitoes will be assessed by membrane feeding assays at two time points.


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


NCT number NCT02259426
Study type Interventional
Source London School of Hygiene and Tropical Medicine
Contact
Status Completed
Phase Phase 3
Start date October 2014
Completion date December 2015

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 NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02527005 - A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients Phase 1