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Not Yet Recruiting NCT07430592

This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria

Conditions: Malaria, Malaria Vivax, Radical Cure

Sex: All
Ages: 18 Years – 76 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 104
Sponsor: R. Kiplin Guy

Location: Asociación Civil Selva Amazónica (ACSA) Iquitos Loreto

Summary

The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafenoquine.

Eligibility Criteria

Inclusion Criteria: * Body weight between 45 kg and 90 kg inclusive. * Presence of mono-infection of P. vivax confirmed by: Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood * Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations. * Ability to swallow oral medication. * Ability and willingness to participate and to comply with the study requirements. * Agreement to hospitalization for at least 72 hours and/or until malarial parasites are not detected by microscopy on 2 consecutive occasions. * Agreement to come back to the hospital on Days 4, 7, 14, 21, 28, 35, 42, 60, 120, and 180. * A female participant meets eligibility in this study if she is non-pregnant, non-lactating and if she is of: non-childbearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or \40 mIU/mL), pre-menopausal and has had a hysterectomy, a bilateral oophorectomy (removal of the ovaries), or a bilateral tubal ligation with medical report verification, negative pregnancy test or, child-bearing potential, with a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 75 days after stopping study treatment: i. Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone, used in conjunction with barrier method (condom or diaphragm). ii. Use of an intrauterine device with a documented failure rate of \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07430592). StuddyBuddy aggregates publicly available trial information.