Short Course Radical Cure of P. Vivax Malaria in Nepal

Status Active, not recruiting

Clinical Trial Summary

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Clinical Trial Description

Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections. The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control. This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04079621
Study type	Interventional
Source	Menzies School of Health Research
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	October 27, 2021
Completion date	March 31, 2024

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Withdrawn	`NCT04020653` - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on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	`NCT02909712` - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania	Phase 2
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
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