Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs.

Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Mahidol University; National Malaria and Leishmaniasis Control Program, Afghanistan
• Treatments: Chloroquine; Chloroquine diphosphate; Primaquine

Criteria

Inclusion Criteria:

• Adults and children >6 months

• Negative pregnancy test in women at risk of pregnancy

• Microscopic diagnosis of Plasmodium vivax mono-infection (>200/µl asexual forms)

• Axillary temperature ≥37.5°C or oral/rectal temperature ≥38°C or history of fever within the last 24 hours

• Ability to swallow oral medication

• Participant (or parent/guardian if <18 years old) is willing and able to give written informed consent

• Ability (in the investigator's opinion) and willingness of patient or parent/guardian to comply with all study requirements

Exclusion Criteria:

• Severe malaria (see WHO definition)

• Patients with microscopic diagnosis of co-infection with Plasmodium falciparum

• Haemoglobin concentration <8g/dl

• Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study e.g. other acute febrile conditions or chronic disease

• Pregnancy or lactation

• History or phenotypic test compatible with severe G6PD deficiency

• History of hypersensitivity to any of the drugs being tested