None listed
Conditions
Brief summary
This primary aim of this study is to detect and treat people who have asymptomatic malaria in four communes in two provinces of central Vietnam during the malaria season of 2021. People with RT-qPCR positive finger prick blood samples for malaria infections will be treated with first-line antimalarial treatment drugs. Initially, 400 asymptomatic people (i.e. without symptoms of malaria such as fever, headaches, nausea and fatigue) will be screened in high malaria risk areas (forest fringes and forested areas) based on previous communal health station historical records (2018-2020) of where symptomatic malaria patients lived or worked. Another 800 asymptomatic people who live and work near symptomatic malaria patients that are treated during the malaria season of 2021 at the same field sites under the concurrently runned VDCP01 study (Therapeutic efficacy surveillance of malaria treatment and drug resistance monitoring in Gia Lai and Phu Yen provinces of Central Vietnam) will also be screened for asymptomatic malaria. We aim to treat up to 60 patients (1,200 x 5% estimated prevalence rate) with asymptomatic malaria with a follow-up period of three months (Days 30, 60 and 90 post commencement of treatment) to determine the efficacy of the drugs. The secondary aims are to determine the prevalence of G6PD deficiency in the study population for the future use of tafenoquine for the elimination of vivax malaria and the potential of the Gazelle (Hemex) device to detect the presence of parasite hemozoin in people with asymptomatic malaria as a point-of-care diagnostic tool.The findings will inform on treatment response of people with asymptomatic malaria to assist in developing new strategies for malaria elimination.
Interventions
Focal case detection surveillance for asymptomatic malaria and its treatment of P. falciparum malaria with the first-line artemisinin-based combination therapy, a standard 3-day course of Pyramax® (pyronaridine-artesunate) plus a single oral dose of primaquine or a 3-day course of chloroquine plus a 14 day course of primaquine for P. vivax malaria for people living and working in selected communes in Krong Pa district (Gia Lai province) and Song Hinh district (Phu Yen province).
People (up 12
Focal case detection surveillance for asymptomatic malaria and its treatment of P. falciparum malaria with the first-line artemisinin-based combination therapy, a standard 3-day course of Pyramax® (pyronaridine-artesunate) plus a single oral dose of primaquine or a 3-day course of chloroquine plus a 14 day course of primaquine for P. vivax malaria for people living and working in selected communes in Krong Pa district (Gia Lai province) and Song Hinh district (Phu Yen province). People (up 1200) without symptoms of malaria such as fever, headache, nausea and fatigue will be invited to provide a finger prick blood sample (0.25 mL) for reverse transcription-quantitative polymerase chain reaction (RT-qPCR) detection of malaria infections. Asymptomatic participants diagnosed by RT-qPCR to be infected with P. falciparum will be treated with pyronaridine-artesunate to kill the blood asexual stages. Each tablet of pyronaridine-artesunate contains 60 mg artesunate + 180 mg pyronaridine. The dose of pyronaridine-artesunate will be in accordance to the participant's body weight with the target dosage range for pyronaridine–artesunate of 15.0 to 8.3 mg/kg/day of body weight for pyronaridine and 5.0 to 2.5 mg/kg/day of body weight for artesunate. Pyronaridine–artesunate will be administered orally, at about 24 hour intervals for the 3 consecutive days. Also, on the first day of treatment patients will be coadministered a single oral dose of primaquine (0.5 mg/kg, each tablet contains 7.5 mg base of primaquine) to kill sexual stages of falciparum malaria to prevent transmission. Pyronaridine-artesunate and primaquine dosing will be observed and recorded in the participant's case report form (CRF). Asymptomatic participants diagnosed to be infected with P. vivax by RT-qPCR will be treated with chloroquine diphosphate (each tablet contains 150 mg chloroquine base) at a dose of 10 mg/kg on days 0 and 1, followed with 5 mg/kg on day 2 (total 25 mg/kg over 3 days) at about 24 hour intervals. Primaquine dosing will also commence on day 0 with chloroquine at a dose of 0.25 mg/kg daily for 14 days (each tablet contains 7.5 mg of primaquine base). Co-administration of chloroquine and primaquine will be observed and recorded in the participant's CRT over the first three days of dosing with the following 11 days of primaquine daily dosing unsupervised. Where Plasmodium speciation cannot be determined by RT-qPCR due to very low parasitemia but the asymptomatic malaria patient is RT-qPCR positive a treatment course of 3 days of pyronaridine-artesunate plus a single oral dose of primaquine will be administered as described above for the treatment of falciparum malaria.
Sponsors
Australian Defence Force Malaria and Infectious Disease Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Gender: Males and females; • Children (5 to <18 years old) and adults; • People without malaria symptoms such as fever, chills, headache and tiredness; • Working or residing at and near the study communes, including forested areas near the communes; • 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.
Exclusion criteria
• Rapid diagnostic test and blood film microscopy positive for malaria infections; • Inability to communicate well with the study staff (poor mental development or evidence of psychiatric disorder); • 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.
Outcome results
None listed