Improving the radical cure of vivax malaria (IMPROV)

Not Applicable

Completed

• Conditions: P. vivax malaria; Infections and Infestations

• Registration Number: ISRCTN16273289
• Lead Sponsor: Oxford University

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26643116

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-18
• Study Completion: 2018-02-28
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1875

Inclusion Criteria

Participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial; verbal consent in the presence of a literate witness is required for illiterate patients. In addition, written assent (or verbal assent in the presence of a literate witness for illiterates) from children 12 to 17 years as per local practice.

1. Monoinfection with P. vivax of any parasitaemia in countries which use Chloroquine (CQ) as blood schizontocidal therapy. Mixed infections with P. vivax and P. falciparum can be enrolled in countries which use an artemisinin combination therapy
2. Diagnosis based on rapid diagnostic tests
3. Over 6 months of age
4. Weight 5 kg or greater
5. Fever (axillary temperature 37.5 degrees C) or history of fever in the last 48 hours
6. Able, in the investigators opinion, and willing to comply with the study requirements and follow-up

Exclusion Criteria

1. Female participant who is pregnant, lactating or planning pregnancy during the course of the study
2. Inability to tolerate oral treatment
3. Previous episode of haemolysis or severe haemoglobinuria following primaquine
4. Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment- Haemoglobin concentration less than 9 g/dL
5. Known hypersensitivity or allergy to the study drugs
6. Blood transfusion in last 90 days, since this can mask G6PD deficient status
7. A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration)
8. 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); coadministration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens
9. Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs
10. Prior antimalarial medications in the previous 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified