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.
Investigators
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
Completed
Not Applicable
Drug resistance studies of antimalarial medicines.CTRI/2017/11/010703WHO GMP225
Completed
Not Applicable
Effectiveness of a Malaria treatment and prevention training program on Patent Medicine Vendor's knowledge, attitudes and practicesMalariaPACTR201508001215416292
Completed
Phase 2
Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventionsmalariaPlasmodium falciparum10037072NL-OMON44645Radboud Universitair Medisch Centrum32
Completed
Not Applicable
Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventionsNL-OMON44291Radboud Universitair Medisch Centrum24
Recruiting
Not Applicable
Efficacy and Safety of Artemether- Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Selected Upazila of Chittagong Hill Tracts (CHT), BangladeshResistance status of uncomplicated P. falciparum malaria against Artemether-lumefantrineFeveruncomplicated P.falciparum parasiteACTRN12618001569291Ministry of Health and Family Affairs120