MedTrace Logo

"Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania"

NCT03241901 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2018-03-27

No results posted yet for this study

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.

Conditions

  • Malaria,Falciparum

Interventions

DRUG

Artemether-Lumefantrine Tab 20-120mg

Artemether-Lumefantrine Tablet 20-120mg

DRUG

Primaquine Phosphate 0.25 mg/kg

Primaquine Phosphate 0.25 mg/kg

OTHER

Placebo

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

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • The University of Western Australia

    collaborator OTHER

  • Muhimbili University of Health and Allied Sciences

    lead OTHER

Principal Investigators

  • Lwidiko E Mhamilawa, MD · Muhimbili University of Health and Allied Sciences

  • Andreas Martensson, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-27
Primary Completion
2017-12-28
Completion
2018-02-17

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241901 on ClinicalTrials.gov