Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Vivax Malaria Clinical Trial

Official title:

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706130
• Other study ID #: 20-0010
• Status: Recruiting
• Phase: Phase 4
• Start date: April 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.

Description:

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization-approved drugs will be used at dosage and for conditions approved.

Eligible patients willing to participate will first be tested prior to enrolment for their glucose-6-phosphate dehydrogenase (G6PD) status by the gold standard spectrophotometric analysis. The investigators will exclude from the study any G6PD deficient (or intermediate females) patient. Treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be relocated to a no-transmission city to make sure they are not reinfected during the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be followed monthly for three months after the end of the relocation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Age 15 and older

• Acute (within 10 days), symptomatic (i.e., history of fever), uncomplicated malaria caused solely by Plasmodium vivax (verified by PCR)

• G6PD normal (as determined by quantitative spectrophotometric assay)

Exclusion Criteria:

• Pregnant, planning to become pregnant or lactating women,

• Received antimalarial drugs in the past month,

• Hb < 8g/dL, < 1,500 neutrophils/µl, or signs of complicated malaria (e.g., vomiting, convulsions,…),

• History of primaquine, artesunate or artesunate-mefloquine allergy or intolerance,

• PCR-positivity for severe acute respiratory syndrome coronavirus 2.

Related Conditions & MeSH terms

• Malaria, Vivax
• Vivax Malaria

Intervention

Drug:
• Primaquine
After treatment of the blood stage infection, enrolled participants will receive either no primaquine, a low dose of primaquine or a high dose of primaquine against liver parasites
• Artesunate
All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites

Locations

Country	Name	City	State
Cambodia	Institut Pasteur du Cambodge	Phnom Penh

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Institut Pasteur du Cambodge, National Centre for Parasitology, Entomology and Malaria Control, Cambodia

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P. vivax recurrence	Proportion of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence	3 months
Primary	Markers of P. vivax recurrences	Gene expression or serological markers associated with P. vivax recurrence	3 months
Secondary	Genotypes of relapsing P. vivax parasites	Genotypes of relapsing P. vivax parasites	3 months