Skip to main content
Clinical Trials/ACTRN12621001085864
ACTRN12621001085864
Recruiting
Phase 4

Therapeutic efficacy surveillance of malaria treatment and drug resistance monitoring in Gia Lai and Phu Yen provinces of Central Vietnam

Australian Defence Force Malaria and Infectious Disease Institute0 sites210 target enrollmentAugust 17, 2021

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Australian Defence Force Malaria and Infectious Disease Institute
Enrollment
210
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 17, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Australian Defence Force Malaria and Infectious Disease Institute

Eligibility Criteria

Inclusion Criteria

  • People infected with uncomplicated mono\-infections of P. falciparum and uncomplicated mono\-infections of P. vivax;
  • Malaria parasite density of P. falciparum (\= 500 to \< 100,000 parasites/µL);
  • Malaria parasite density of P. vivax (\= 250 parasites/µL);
  • Children (\=5 years and \=20 kg to \<18 years old) and adults (\=18 to \<60 years old) infected with P. falciparum, children (\=5 to \<18 years old) and adults (\=18 to \<60 years old) infected with P. vivax malaria;
  • Gender: Males and females;
  • Working or residing at the study commune;
  • Able to provide information and capillary finger prick blood samples;
  • Written informed consent given to participate in the study by the adult or in case of children up to \<18 years old (Assent form for children aged 12 to \<18 years old) with parent or guardian permission;
  • Normal G6PD enzyme activity levels (\>70%) of the site median value for G6PD normals for participants to be treated with primaquine for the radical cure of P. vivax malaria.

Exclusion Criteria

  • People not infected with malaria infections;
  • Children (\<5 years old and \<20 kg)infected with P. falciparum and less than 5 years of age infected with P. vivax malaria;
  • Unwilling to provide consent, information, and capillary finger prick blood sample;
  • Inability to communicate well with the study staff (poor mental development or evidence of psychiatric disorder);
  • People with P. vivax malaria who have G6PD deficient enzyme activity;
  • Pregnant or lactating females;
  • Any condition that in the judgment of the IMPE\-QN/MIPM doctor would make participation in the study unsafe for the potential participant.

Outcomes

Primary Outcomes

Not specified

Similar Trials