Malaria Clinical Trial
— PRIMAOfficial title:
Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial
Verified date | November 2023 |
Source | Menzies School of Health Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Status | Completed |
Enrollment | 500 |
Est. completion date | July 30, 2022 |
Est. primary completion date | May 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility | Inclusion Criteria: - P. falciparum mono-infection - Fever (axillary temperature =37.5°C) or history of fever in preceding 48 hours - Age >1 years (= 18 years at the Ethiopia site) - G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at =70% of the adjusted male median (AMM) for each site - Written informed consent - Able to comply with all study procedures and timelines Exclusion Criteria: - General danger signs or symptoms of severe malaria - Anaemia, defined as Hb <8g/dl - Pregnant women as determined by Urine ß-HCG pregnancy test - Breast feeding women - Known hypersensitivity to any of the drugs given - Regular use of drugs with haemolytic potential - Blood transfusion within the last 4 months |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Icddrb | Upazila | |
Ethiopia | Arba Minch University | Arba Minch | |
Indonesia | Puskesmas Mangili | Dusun Tenggara |
Lead Sponsor | Collaborator |
---|---|
Menzies School of Health Research | Addis Ababa University, Arba Minch University, International Centre for Diarrhoeal Disease Research, Bangladesh, Tribhuvan University, Nepal |
Bangladesh, Ethiopia, Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence risk of any P. vivax parasitaemia at day 63 | The incidence risk of any P. vivax parasitaemia at day 63 | 63 days | |
Secondary | Incidence risk of symptomatic P. vivax parasitaemia at day 63 | incidence risk of symptomatic P. vivax parasitaemia at day 63 | 63 days | |
Secondary | Incidence risk of all any P. vivax parasitaemia at day 28 and 42 | Incidence risk of all any P. vivax parasitaemia at day 28 and 42 | 28 and 42 days | |
Secondary | Incidence risk of any P. falciparum malaria at day 28, 42 and 63 | incidence risk of any P. falciparum malaria at day 28, 42 and 63 | 28/42/63 days | |
Secondary | proportion of patients vomiting their medication within 1 hour of administration | proportion of patients vomiting their medication on the day of enrollment within 1 hour of administration | 1 hour | |
Secondary | proportion of patients vomiting any of their PQ doses within 1 hour of administration | proportion of patients vomiting any of their PQ doses within 1 hour of administration | 7 days | |
Secondary | proportion of adverse events and serious adverse events | proportion of adverse events and serious adverse events | 63 days | |
Secondary | incidence risk of severe anaemia (Hb<5g/dl) and moderately severe anaemia (<7g/dl) and/or the risk for blood transfusion between day 3 and 7 | incidence risk of severe anaemia (Hb<5g/dl) and moderately severe anaemia (<7g/dl) and/or the risk for blood transfusion between day 3 and 7 | 7 days | |
Secondary | • The incidence risk of =25% fall in haemoglobin since baseline with and without hemoglobinuria at day 3 and day 7 | • The incidence risk of =25% fall in haemoglobin since baseline with and without hemoglobinuria at day 3 and day 7 | 7 days | |
Secondary | The incidence risk of =25% fall in haemoglobin to under 7g/dl with and without hemoglobinuria at day 3 and day 7 | The incidence risk of =25% fall in haemoglobin to under 7g/dl with and without hemoglobinuria at day 3 and day 7 | day 7 | |
Secondary | Incidence risk of P. falciparum gametocytaemia between day 7 and 63 | Incidence risk of P. falciparum gametocytaemia between day 7 and 63 | 63 days | |
Secondary | Parasite clearance on day 1, 2 and 3 | Parasite clearance on day 1, 2 and 3 | 3 days | |
Secondary | Fever clearance on day 1, 2 and 3 | Fever clearance on day 1, 2 and 3 | 3 days |
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