MedTrace Logo

In-vivo Efficacy and Safety of Artemether/Lumefantrine Vs Dihydroartemisinin-piperaquine for Treatment of Uncomplicated Malaria and Assessment of Parasite Genetic Factors Associated With Parasite Clearance or Treatment Failure

NCT02590627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2017-12-26

No results posted yet for this study

Summary

Drug efficacy testing is one of the most important tasks that is routinely undertaken by the National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT) and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.

Conditions

Interventions

DRUG

Artemether-lumefantrine

Artemether-lumefantrine

DRUG

Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine

Sponsors & Collaborators

  • Ministry of Health and Social Welfare, Tanzania

    collaborator OTHER_GOV

  • World Health Organization

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    lead OTHER_GOV

Principal Investigators

  • Deus Ishengoma, PHD · National Institute for Medical Research

  • Celine Mandara, MD, Msc · National Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases
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 NCT02590627 on ClinicalTrials.gov