IMPROV (Improving the Radical Cure of Vivax Malaria)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01814683
• Date of registration: 18/03/2013
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: IMPROV (Improving the Radical Cure of Vivax Malaria)
• Scientific title: Improving the Radical Cure of Vivax Malaria: A Multicentre Randomised Comparison of Short and Long Course Primaquine Regimens
• Date of first enrolment: July 2014
• Target sample size: 2388
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01814683
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Afghanistan, Ethiopia, Indonesia, Pakistan, Vietnam

Contacts

• Name: Ric Price, FRCP
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

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.

- 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 Criteria:

- 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.



Age minimum: 6 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Uncomplicated Vivax Malaria

Intervention(s)

Drug: Placebo

Drug: Primaquine

Primary Outcome(s)

Incidence rate (per person-year) of symptomatic recurrent P. vivax [Time Frame: 12 months]

Secondary Outcome(s)

The Haematological recovery in patients with vivax malaria [Time Frame: 12 months]

Primaquine tolerability [Time Frame: 14 days]

Incidence risk of severe anaemia in G6PD deficient arm [Time Frame: 14 days]

The incidence rate (per person-year) of any recurrent P. vivax malaria. [Time Frame: 12 months]

Cost effective analysis in the management of P. vivax with respect to the use of G6PD tests [Time Frame: 12 months]

Incidence risk of any recurrent symptomatic of P. vivax malaria compared to control arm [Time Frame: 12 months]

Primaquine tolerability comparison between patients in intervention arm and control arm [Time Frame: 14 days]

Proportion of patients with Serious Adverse Drug reactions [Time Frame: 12 months]

Secondary ID(s)

BAKMAL 1301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Menzies School of Health Research