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Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar

NCT03773536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2018-12-12

No results posted yet for this study

Summary

The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar.

The specific objectives are:

* To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection.
* To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR).
* To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine.
* To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance/resistance.
* To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not.
* To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Artesunate-amodiaquine given with single low dose primaquine

Three day treatment with ASAQ with SLD primaquine given with the first dose of ASAQ.

Sponsors & Collaborators

  • Ministry of Health and Social Welfare, Zanzibar

    collaborator OTHER_GOV

  • Zanzibar Malaria Elimination Programme

    collaborator OTHER_GOV

  • Uppsala University

    collaborator OTHER

  • Professor Anders Björkman

    lead OTHER

Principal Investigators

  • Mwinyi I Msellem · Mnazi mmoja hospital, Zanzibar Ministry of Health

  • Abduallah S Ali · Zanzibar Malaria Elimination Programme

  • Andreas Martensson · Uppsala University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2017-09-25
Completion
2017-09-25

Countries

  • Tanzania

Study Locations

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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 NCT03773536 on ClinicalTrials.gov