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Malaria, Vivax clinical trials

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NCT ID: NCT04704999 Not yet recruiting - Clinical trials for Plasmodium Vivax Malaria

Southeast Asia Dose Optimization of Tafenoquine

SEADOT
Start date: August 1, 2024
Phase: Phase 4
Study type: Interventional

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.

NCT ID: NCT04416945 Recruiting - Clinical trials for Plasmodium Falciparum Malaria

Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic

COMBAT
Start date: September 20, 2020
Phase: N/A
Study type: Interventional

This study assesses the effectiveness and feasibility of enhanced reactive case detection (RACD) targeting high-risk villages and forest workers for reducing Plasmodium falciparum and Plasmodium vivax transmission in southern Lao Peoples Democratic Republic. The authors hypothesize that enhanced community-based RACD will be more effective than standard of care case management and RACD at reducing P. falciparum and P. vivax confirmed case incidence and parasite prevalence over an 18-month period in Lao Peoples Democratic Republic.

NCT ID: NCT04411836 Recruiting - Malaria, Vivax Clinical Trials

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

EFFORT
Start date: April 25, 2021
Phase: Phase 3
Study type: Interventional

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

NCT ID: NCT04368910 Terminated - Malaria Clinical Trials

Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria

Start date: September 6, 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax (P. vivax) malaria

NCT ID: NCT04228315 Recruiting - Malaria Clinical Trials

Biomarkers of P. Vivax Relapse

Start date: November 19, 2019
Phase: N/A
Study type: Interventional

Plasmodium vivax malaria is difficult to manage because even after taking medicine that kills the infection in the blood, it can continue to hide quietly in the liver, later re-emerging into the blood and causing another episode of malaria illness (relapse). This clinical trial aims to enroll patient with P. vivax infections and try to detect signals in blood, urine and/or saliva coming from the silent liver stages to help identify who could benefit from treatment with primaquine. It also will explore if certain factors of patients negatively impact primaquine efficacy.

NCT ID: NCT04223674 Active, not recruiting - Malaria, Vivax Clinical Trials

Serological Screen and Treat Trial for Plasmodium Vivax

SSAT
Start date: February 9, 2022
Phase: N/A
Study type: Interventional

This is a clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to evaluate the efficacy of serological screening vs. routine care for the prevention of recurrent P. vivax infections. A total of 960 schoolchildren will be randomized into the interventional or control arm.

NCT ID: NCT04222088 Completed - Malaria Clinical Trials

TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014

TES
Start date: May 1, 2013
Phase:
Study type: Observational

An antimalarial drug efficacy trial was conducted for artemether-lumefantrine (AL) and chloroquine (CQ) in the three (3) municipalities (Bataraza, Brookes and Rizal) of Palawan. Study subjects are febrile individuals between > 6 months old and 59 years old with confirmed uncomplicated P. falciparum or P. vivax infections. Patients with P. falciparum was treated with Artemether-lumefantrine administered 3 days (Days 0, 1 and 2) according to body weight. Primaquine at 0.75 mg base/kg body weight single dose was given on Day 3. For Plasmodium vivax patients chloroquine were administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2), and primaquine following the National Treatment Guidelines. During the period that this report covers, 84 and 75 patients met the inclusion criteria for Pf and Pv respectively. Clinical and parasitological parameters were monitored over a 28-day follow-up period for both drugs. The presence of only 1 Late Clinical Failure (LCF) of P. falciparum parasitemia out of 84 enrolled patients and 2 Late Parasitological Failure (LPF) of P. vivax patients out of 75 enrolled patients within the 28 days follow up suggest that both drugs are still efficacious.

NCT ID: NCT04201431 Recruiting - Malaria, Vivax Clinical Trials

Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1

Start date: January 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an Open label, first-in-human, Phase I/IIa, blood-stage P. vivax malaria vaccine trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium vivax malaria vaccine candidate PvDBPII in Matrix M1 in healthy adults living in the UK.

NCT ID: NCT04083508 Recruiting - Clinical trials for Plasmodium Vivax Infection

Vivax Malaria Human Infection Studies in Thailand

MIST1
Start date: October 5, 2020
Phase: N/A
Study type: Interventional

This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocytaemia. This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A.

NCT ID: NCT04079621 Active, not recruiting - Malaria Clinical Trials

Short Course Radical Cure of P. Vivax Malaria in Nepal

Start date: October 27, 2021
Phase: Phase 4
Study type: Interventional

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.