EFFECTIVENESS OF THREE DIFFERENT PRIMAQUINE SCHEMES, FOR THE PREVENTION OF MALARIA BY PLASMODIUM VIVAX IN THE AMAZON REGION OF PER

Not Applicable

• Conditions: -B54 Unspecified malaria; Unspecified malaria; B54

• Registration Number: PER-068-04
• Lead Sponsor: INSTITUTO DE INVESTIGACION DE ENFERMEDADES TROPICALES DE LA MARINA DE LOS E.E.U.U (NMRCD), Instituto Nacional de Salud - INS (Peru),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-10-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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 <15% or clinical signs)
c. Renal failure (serum creatinine> 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Evaluate the efficacy of three different primaquine regimens to prevent relapse in patients with P. vivax malaria<br>Measure:Efficacy<br>Timepoints:During treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br>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).<br>Measure:antimalarial resistance<br>Timepoints:17-35 days<br>;<br>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).<br>Measure:relapse and reinfection<br>Timepoints:35 days<br>