Clinical trial NCT04706130: Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Official title: Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vivax Malaria
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Centre for Parasitology, Entomology and Malaria Control, Cambodia
name: Institut Pasteur du Cambodge
First posted: 2021-01-12
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: P. vivax recurrence
timeFrame: 3 months
measure: Markers of P. vivax recurrences
timeFrame: 3 months
Secondary outcomes:
measure: Genotypes of relapsing P. vivax parasites
timeFrame: 3 months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Institut Pasteur du Cambodge
Study officials:
References: