Status:
WITHDRAWN
Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Pan American Health Organization
Conditions:
Malaria, Vivax
Relapse
Eligibility:
All Genders
5-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Malaria due to Plasmodium vivax (P. vivax) is still a public health challenge in the Americas. In recent years, the rate of decline in the incidence of P. vivax malaria has stalled in the Americas. To...
Eligibility Criteria
Inclusion
- Age ≥5 years
- Fever (T≥37.5 ⁰C, oral) and/or history of fever in the previous 48 hours
- P. vivax mono-infection
- Normal G6PD status using Biosensor™ (SD Bioline, ROK) (G6PD activity ≥ 70% of the adjusted male median (AMM))
- Written informed consent
- Living in the study area and willing to be followed for six months
Exclusion
- Malaria treatment in the previous 30 days,
- Self-reported chronic disease (including severe cardiac, hepatic, or renal disorders, malnutrition, or HIV),
- Clinically significant concurrent illness,
- Use of medications known to interfere with the pharmacokinetics of PQ or CQ,
- Known hypersensitivity to any of the study drugs,
- Use of an investigational drug within the previous 30 days or five half-lives (whichever was longer),
- History of moderate or severe adverse reaction to any of the study drugs,
- Hemoglobin \< 7 g/dL,
- Pregnancy (by urine pregnancy test) or breastfeeding,
- Not able to take oral treatment,
- Signs of severe malaria:
- Unable to drink
- Vomiting (more than twice in the previous 24 hours)
- Recent history of convulsions (one or more in the previous 24 hours)
- Impaired consciousness
- Unable to sit or stand
- Cerebral malaria (unarousable coma)
- Severe anemia (hematocrit \<15% or clinical signs) hemoglobin \<5 mg/ml) (Note: we will use hemoglobin less than 7 mg/ml as exclusion criteria)
- Renal failure (serum creatinine \>3 mg/dL or clinical signs)
- Pulmonary edema
- Hypoglycemia (blood glucose \<40mg/dL or clinical signs)
- Shock (systolic blood pressure \<70 mm Hg in adults; 50 mm Hg in children)
- Spontaneous bleeding/disseminated intravascular coagulation.
- Repeated generalized convulsions
- Acidemia/acidosis (clinical signs)
- Macroscopic hemoglobinuria
- Jaundice●
Key Trial Info
Start Date :
January 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05232227
Start Date
January 20 2023
End Date
October 30 2023
Last Update
May 11 2023
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