CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 280 enrolled
Drug / intervention
Artemether-Lumefantrine Tab 20-120mg +2 moredrug
Likely dose
Artemether-Lumefantrine Tab 20-120mgfrom 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/NCT03241901
NCT03241901Phase 4Completed

"Aiming at Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in an Era of Imminent Plasmodium Falciparum Resistance in Bagamoyo District, Tanzania - New Strategies With Old Tools"

Muhimbili University of Health and Allied Sciences·interventional·Posted Aug 8, 2017·Updated Mar 27, 2018

In Brief

A Phase 4 clinical trial evaluating Artemether-Lumefantrine Tab 20-120mg, Primaquine Phosphate 0.25 mg/kg, and 1 other intervention for Malaria,Falciparum. Completed, enrolled 280 participants across 2 sites.

Detailed Summary

This clinical trial evaluates the advantage of prolonging the therapeutic life span of Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine 0.25mg/kg. The study will have two arms, one that will receive standard treatment of uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the prolonged dose of 6 days together with single low dose primaquine. This approach is expected to provide strategies for malaria control in an era of imminent Plasmodium falciparum resistance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTanzania

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 8, 2017
Enrollment StartJul 27, 2017
Primary CompletionDec 28, 2017
Study CompletionFeb 17, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago

Interventions

Artemether-Lumefantrine Tab 20-120mgdrug

Artemether-Lumefantrine Tablet 20-120mg

Primaquine Phosphate 0.25 mg/kgdrug

Primaquine Phosphate 0.25 mg/kg

Placeboother

Aqueous solution prepared to mimic the taste of the intervention drug.