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

Phase 4

Recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12621001085864
• Lead Sponsor: Australian Defence Force Malaria and Infectious Disease Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified