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A RANDOMIZED OPEN HOSPITAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DIHYDROARTEMISININE-PIPERRAINE (ARTEKIN) FOR THE TREATMENT OF MALARIA NOT COMPLIATED BY PLASMODIUM FALCIPARUM IN IQUITOS, PERU.

A RANDOMIZED OPEN HOSPITAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DIHYDROARTEMISININE-PIPERRAINE (ARTEKIN) FOR THE TREATMENT OF MALARIA NOT COMPLIATED BY PLASMODIUM FALCIPARUM IN IQUITOS, PERU.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-032-03
Enrollment
441
Registered
2003-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Artekin Type of group
Artekin (dihydroartemisinin + piperaquine) will be administered
MAS3 Type of group
MAS3 (Mefloquine + Artesunate) will be administered each tablet containing artesunate 4 mg/kg/day, once a day for 3 days plus mefloquine 24 mg / kg as the total dose, administered as a three-day schedule of 8 mg/kg/day .

Sponsors

IMTAP-AMBERES, BELGICA,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age: 5-60 years. • Fever (body temperature> 37.5 ° C) or history of fever in the previous 24 hours. • Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 / ul • Written informed consent to participate in the study. For patients under the age of 18, informed consent will be obtained from a family member (father or mother) or guardian; In addition, the Child´s Assent must be counted.

Exclusion criteria

Exclusion criteria: • Mixed malaria infection • Pregnancy and / or lactation (a p-test of HCG in urine will be performed on every woman of childbearing age unless she is menstruating). • Concomitant disease. • History of mefloquine treatment within 60 days before the current episode. • History of seizures or neuropsychiatric disease.

Design outcomes

Primary

MeasureTime frame
Outcome name:Changes in the patient of clinical condition in response to a conventional dose of an antimalarial drug. Measure:To evaluate the new Artekin ® combination for the treatment of patients with uncomplicated Plasmodium falciparum malaria. Timepoints:63 days—

Secondary

MeasureTime frame
Outcome name:Medical history, medical examination, and blood test for thick blood, hemoglobin / hematocrit, transaminase (TGO, TGP), alkaline phosphatase, total and fractionated Büirrubina, albumin, electrolytes, urea and creatinine dosages and for tests of parasite genotyping and pharmacokinetics. Measure:Study the pharmacokinetics of piperaquine and mefloquine by means of a population-based study. Timepoints:63 days—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)