Status:
COMPLETED
IMPROV (Improving the Radical Cure of Vivax Malaria)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Menzies School of Health Research
Conditions:
Uncomplicated Vivax Malaria
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Previous trials have demonstrated that the standard low dose regimen of prima...
Detailed Description
Plasmodium vivax malaria is a major cause of morbidity and now recognised as an important contributor to mortality in endemic areas. Unlike P. falciparum malaria, P. vivax infections form dormant live...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Diagnosis based on rapid diagnostic tests.
- Over 6 months of age.
- Weight 5 kg or greater.
- Fever (axillary temperature 37.5 degrees C) or history of fever in the last 48 hours.
- Able, in the investigators opinion, and willing to comply with the study requirements and follow-up.
Exclusion
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Inability to tolerate oral treatment.
- Previous episode of haemolysis or severe haemoglobinuria following primaquine
- Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment- Haemoglobin concentration less than 9 g/dL
- Known hypersensitivity or allergy to the study drugs
- Blood transfusion in last 90 days, since this can mask G6PD deficient status
- A febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration)
- 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.
- Currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs.
- Prior antimalarial medications in the previous 7 days.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
2388 Patients enrolled
Trial Details
Trial ID
NCT01814683
Start Date
July 1 2014
End Date
February 28 2018
Last Update
September 17 2019
Active Locations (8)
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1
Provincial Malaria & Leishmania control program (PMLCP) Nangarhar
Jalalabad, Nangarhar, Afghanistan
2
Laghman Provincial Hospital
Laghmān, Afghanistan
3
Metahara Sugar Factory Hospital
Metehara, Oromiya, Ethiopia
4
Arba Minch Hospital
Ārba Minch, Snnpr, Ethiopia