N/A
N=254
Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil
P Vivax · Malaria, Vivax
Bottom Line
View on ClinicalTrials.gov: NCT03610399 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled — 61; 88; 90 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Primaquine (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled |
29; 44; 67 | — |
| PRIMARY Participants With Adequate Clinical and Parasitologic Response Among Patients Enrolled |
29; 44; 67 | — |
| SECONDARY Participants With Adequate Clinical and Parasitologic Response Based on Microsatellite-corrected Analysis Per Protocol Day 168 |
29; 44; 67 | — |
Summary
We plan to assess the efficacy of 3 different regimens of chloroquine and primaquine for the treatment of P. vivax infections in Cruzeiro do Sul, Acre, Brazil. Patients will be divided in 3 different groups: treatment with regular dose of primaquine (0.5 mg/kg per day for 7 days) with directly observed therapy; regular dose of primaquine without directly observed therapy; and increased total dose of primaquine (0.5 mg/kg per day for14 days) with directly observed therapy. All patients will receive chloroquine (CQ) for three days at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria Control guidelines. Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and for a total period of 168 days (24 weeks) to evaluate chances of recrudescence, relapse, or reinfection. Results from this drug efficacy study will be used to assist the Brazilian Ministry of Health in assessing their national malaria treatment policy for P. vivax malaria.
Eligibility Criteria
Inclusion Criteria
- 1. Age ≥5 years 2. Body weight
- Cerebral malaria (unarousable coma)
- Severe anemia (hematocrit 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/disseminate intravascular coagulation
- Repeated generalized convulsions
- Acidemia/acidosis (clinical signs)
- Macroscopic hemoglobinuria
- Jaundice 3. Self-reported presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, tuberculosis, malnutrition, psoriasis) 4. History of hypersensitivity reactions to any of the drugs being tested. Mild itching with CQ is not in itself a criterion for exclusion. This occurrence will be evaluated by the study doctor before excluding the patient for this reason alone.
- Use of drugs with antimalarial activity in the past 30 days. (Annex D) 6. Current pregnancy (either self-reported being pregnant at enrollment or a positive urine or plasma pregnancy test at time of enrollment), previous pregnancy is not an exclusion criteria 7. Hemoglobin <8 mg/mL 8. G6PD deficiency. This will be a late exclusion criteria as soon as the results of G6PD testing becomes available.
Data sourced from ClinicalTrials.gov (NCT03610399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.