[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100332601":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":48,"collaborators":50,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":35,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":35,"enrollmentInfo":66,"targetDuration":35,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":81,"whyStopped":35,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Centers for Disease Control and Prevention","FED",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Primaquine Regular Dose Unsupervised","OTHER","This is the regular primaquine dose Brazil without directly observed therapy.",[13],"Drug: Primaquine",{"label":15,"type":16,"description":17,"interventionNames":18},"Primaquine Regular Dose Supervised","ACTIVE_COMPARATOR","This is the regular primaquine dose in Brazil but with directly observed therapy.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Primaquine Double Dose Unsupervised","This is the double total primaquine dose (14 days) in Brazil with directly observed therapy.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Primaquine","Different total dose and supervision.",[20,15,9],[30],"Primaquine dose",[32],{"name":33,"affiliation":5,"role":34},"Alexandre Macedo de Oliveira, MD","PRINCIPAL_INVESTIGATOR",null,[37],{"facility":38,"status":35,"city":39,"state":35,"zip":35,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":35},"Hospital do Jurua","Cruzeiro do Sul","Brazil","BR",{"type":43,"coordinates":44},"Point",[45,46],-72.67756,-7.62759,{"lat":46,"lon":45},{"type":49,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[51,54],{"name":52,"class":53},"Ministry of Health, Brazil","OTHER_GOV",{"name":55,"class":10},"Evandro Chagas National Institute of Infectious Disease","100332601","efficacy-of-3-regimens-of-chloroquine-and-primaquine-for-treatment-of-p-vivax-malaria-cruzeiro-do-sul-acre-brazil-100332601",true,"NCT03610399","Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil","Efficacy of Three Regimens of Chloroquine and Primaquine for the Treatment of Plasmodium Vivax Malaria in Cruzeiro do Sul, Acre, Brazil","Inclusion Criteria:\n\n* 1\\. Age ≥5 years 2. Body weight \\\u003C120 kg 3. Documented fever (axillary temperature ≥37.5o C) or history of fever during the previous 48 hours in the absence of another obvious cause of fever, such as pneumonia, otitis media, etc 4. Monoinfection with P. vivax with parasitemia between 100 and 200,000 asexual parasites\u002Fµl as determined by microscopic examination of thick and thin peripheral blood smears 5. Informed consent from the patient or parent\u002Fguardian (for those \\\u003C18 years), assent from child (ages 7 to 17 years inclusive), patients 5 through 6 years old will not need an assent 6. Willingness on the part of the patient to return to the clinic and\u002For receive home visits for regular check-ups during the 24-week (168 days) follow-up period 7. Place of residence within 30-45 minutes of study site.\n\nExclusion Criteria:\n\n* 1\\. Presence of malaria danger signs\n\n  1. Unable to drink\n  2. Vomiting (more than twice in the previous 24 hours)\n  3. Recent history of convulsions (one or more in the previous 24 hours)\n  4. Impaired consciousness\n  5. Unable to sit or stand 2. Presence of signs of severe malaria (WHO criteria)\n\n  \u003C!-- -->\n\n  1. Cerebral malaria (unarousable coma)\n  2. Severe anemia (hematocrit \\\u003C15% or clinical signs) hemoglobin \\\u003C5 mg\u002Fml) (Note: we will use hemoglobin less than 8 mg\u002Fml as exclusion criteria)\n  3. Renal failure (serum creatinine \\>3 mg\u002FdL or clinical signs)\n  4. Pulmonary edema\n  5. Hypoglycemia (blood glucose \\\u003C40mg\u002FdL or clinical signs)\n  6. Shock (systolic blood pressure \\\u003C70 mm Hg in adults; 50 mm Hg in children)\n  7. Spontaneous bleeding\u002Fdisseminate intravascular coagulation\n  8. Repeated generalized convulsions\n  9. Acidemia\u002Facidosis (clinical signs)\n  10. Macroscopic hemoglobinuria\n  11. Jaundice 3. Self-reported presence of other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV\u002FAIDS, 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.\n\n      5\\. 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 \\\u003C8 mg\u002FmL 8. G6PD deficiency. This will be a late exclusion criteria as soon as the results of G6PD testing becomes available.",false,"ALL","5 Years",{"count":67,"type":68},257,"ACTUAL","INTERVENTIONAL",[71],"NA","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\u002Fkg 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\u002Fkg 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\u002FKg 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.",[74,75],"P Vivax","Malaria, Vivax",[77,78,79,80],"treatment response","efficacy","primaquine","chloroquine","COMPLETED","2021-08-05",{"date":84,"type":68},"2021-08-09",{"date":86,"type":68},"2018-04-09",{"date":88,"type":68},"2019-03-12",{"name":5,"class":6},1]