CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Artesunate +1 moredrug
Likely dose
Artesunate 4mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02084602
NCT02084602Phase 4Completed

Assessment of in Vivo and in Vitro Efficacy of Combined Artesunate/Mefloquine Therapy for Treatment of Uncomplicated Plasmodium Falciparum Infection in the Peruvian Amazon

Instituto Nacional de Salud. Peru·interventional·Posted Mar 12, 2014·Updated Apr 29, 2021

In Brief

A Phase 4 clinical trial evaluating Artesunate and Mefloquine for Malaria, Falciparum. Completed, enrolled 45 participants across 1 site.

Detailed Summary

There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border. The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 12, 2014
Enrollment StartJun 18, 2014
Primary CompletionNov 6, 2015
Study CompletionApr 13, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.3 years ago

Interventions

Artesunatedrug

Orally administration of artesunate 4mg/Kg by three days

Mefloquinedrug

Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day