P.Vivax Treatment Trial

• Status: Completed
• Trial end date: 2018-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Mahidol Oxford Tropical Medicine Research Unit
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

Criteria

Inclusion Criteria:

• Participants with subclinical mono- or mixed P. vivax infections (uPCR) can be enrolled.

• Able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up.

• A participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial.

Exclusion Criteria:

• Currently pregnant or breastfeeding (female of child-bearing age).

• Inability to tolerate oral treatment.

• Previous episode of haemolysis or severe haemoglobinuria following primaquine.

• Known hypersensitivity or allergy to the study drugs.

• Blood transfusion in last 90 days, since this can mask G6PD deficiency.

• An acute malaria episode requiring treatment.

• A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration).

• Anaemia (Haemoglobin (Hb) < 9 g/dL

• Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal or hepatic disease; severe malnutrition; HIV/AIDS; or severe febrile condition other than malaria); co-administration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens.

• Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs