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Malaria, Vivax clinical trials

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NCT ID: NCT05232227 Withdrawn - Relapse Clinical Trials

Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia

Start date: January 20, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Primaquine (PQ) is the only widely available treatment to prevent P. vivax relapses. World Health Organization recommends increased PQ doses in East Asia and Oceania, frequently relapsing strains. In 2005, the Centers for Diseases Control and Prevention began also recommending higher dose PQ to treat infections from all parts of the world. In Latin America, PQ for a radical cure has been largely implemented as 3.5 mg/kg over 14 days (standard dose, long-course, PQsd14) or 3.5 mg/kg over 7 days (short-course, or PQsd7) in combination with chloroquine (CQ). A recent randomized controlled trial in Brazil showed that a 7 mg/kg double dose regimen over 14 days (PQdd14) was superior in preventing relapses compared to the standard of care regimen in Brazil of 3.5 mg/kg over 7 PQsd7 Direct Observed Therapy (DOT) and PQsd7 without DOT and with or 14 days PQsd14 with DOT (92% versus 66% were relapse-free in the 6-month follow-up in adjusted analyses). These data were presented at the 2019 PAHO Malaria Technical Advisory Group (TAG) meeting. To inform whether there should be a policy change by Panamerican Health Organization, the Malaria TAG recommended more evidence from the results of another trial to confirm the efficacy of high versus low-dose PQ. This project aims to generate the necessary evidence to inform a policy decision regarding high-dose PQ. Impact Malaria (IM) proposes to conduct another trial, per the PAHO Malaria TAG's recommendation, assessing the efficacy of high-dose PQ compared to low-dose PQ. The objective is to compare a standard regimen, which in Colombia is PQsd14 (3,5mg/kg divided in 14 days), to a double dose alternative PQ 7 mg/kg double dose regimen over 14 days (PQdd14).

NCT ID: NCT02696928 Withdrawn - Vivax Malaria Clinical Trials

Methylene Blue Against Vivax Malaria in Ethiopia

BlueAL
Start date: April 2016
Phase: Phase 2
Study type: Interventional

Feasibility of methylene blue-based combination therapy in the radical treatment of adult patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial Study rationale: Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. Primaquine (PQ) is the only registered drug for radical cure of Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West Africa. As there is evidence for MB probably being effective against the hypnozoites of Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination therapy in Plasmodium vivax malaria. Study objectives: The main objective of this trial is to study the feasibility of MB-based combination therapy in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.

NCT ID: NCT00290420 Withdrawn - Malaria Clinical Trials

Prevention of P. Vivax Malaria During Pregnancy in Bolivia

Start date: March 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.