None listed
Conditions
Interventions
Group 1 Type of group
chloroquine, 25 mg / kg for three days, plus primaquine 0.25 mg / kg per day for 14 days
Group name:Group 3 Type of group
chloroquine, 25 mg / kg for three days, plus primaquine 0.5 mg / kg for 5 days
Sponsors
INSTITUTO DE INVESTIGACION DE ENFERMEDADES TROPICALES DE LA MARINA DE LOS E.E.U.U (NMRCD), Instituto Nacional de Salud - INS (Peru),
Eligibility
Inclusion criteria
Inclusion criteria: • Age> 1 year. • Documented fever (axillary temperature> 37.5 ° C) or a history of fever during the past 72 hours in the absence of another obvious cause of fever (such as pneumonia, otitis media). • Monoinfection with P. vivax between 250 and 100,000 asexual parasites / pl determined by microscopic examination of thick drop, or thick drop and peripheral smears. • Informed consent of the patient or parent / guardian (in the case of children), assent of the child (including ages between 8 and 17 years); • Patient´s intention to return to the health center for regular check-ups during a 28-day follow-up period and stay in the locality for 6 months for home visits.
Exclusion criteria
Exclusion criteria: • Signs of danger: not being able to drink or breastfeed; vomiting (more than twice in the previous 24 hours); recent history of seizures (one or more in the previous 24 hours); affected conscience; unable to sit or stand • Signs of severe malaria (WHO criteria) to. Brain malaria (irreversible coma) b. Severe anemia (hematocrit 3 mg / dL or clinical signs) d. Pulmonary edema and. Hypoglycemia (blood glucose <40mg / dL or clinical signs) F. Shock (systolic pressure <70 mm Hg in adults, 50 mm Hg in children) g. Spontaneous bleeding / CID h. Repeated generalized seizures i. Acidemia / acidosis (clinical signs) j. Macroscopic hemoglobinuria k. Jaundice • Other underlying chronic or severe diseases (eg: heart, kidney, liver disease, HIV / AIDS, tuberculosis, malnutrition); which will be diagnosed through the evaluation of the clinical history or the physical examination. • History of hypersensitivity reactions to any of the drugs under evaluation or that are being used as an alternative treatment: quinine, tetracycline or clindamycin) • Pregnancy (both pregnancy antecedent and positive urine pregnancy test). • Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluate the efficacy of three different primaquine regimens to prevent relapse in patients with P. vivax malaria Measure:Efficacy Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Conduct in vitro susceptibility testing of drugs and molecular marker tests to identify single nucleotide polymorphisms (SNPs) that could confer antimalarial resistance on potential CQ-resistant parasites collected from patients with recurrent infections 17-35 days later of the therapy with CQ (chloroquine). Measure:antimalarial resistance Timepoints:17-35 days ; Outcome name:Perform genotyping to distinguish between relapse and reinfection in P. vivax isolates obtained from patients with a recurrent infection of P. vivax 35 days after the therapies with CQ / PQ (chloroquine / primaquine). Measure:relapse and reinfection Timepoints:35 days | — |
Countries
Peru
Outcome results
None listed