Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2013-05-31
2015-05-31
Brief Summary
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While the use of bed nets and other vector control and case management measures have achieved major advances in overall malaria control, the P. vivax and P. ovale species account for an ever-increasing burden of clinical disease.
The lack of effective treatment of the hypnozoite stages of infection with these species result in ongoing relapses and a continuing reservoir of infection.
The only known drug effective for treatment of the hypnozoite stage is primaquine; however the safe and effective dose of this drug in malaria treatment is still unclear.
A recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to replicate this methodology in Vanuatu and Solomon Islands, to provide a more complete picture of primaquine efficacy and safety in each of the three countries of this region.
Detailed Description
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Primary To define and compare the efficacy of standard (0.25mg/kg/day for 14 days) and high-dose (0.5mg/kg/day for 14 days) primaquine in preventing early relapses from P. vivax in Solomon Islands and Vanuatu.
Secondary To measure safety and toxicity of primaquine when administered as a standard or high-dose regimen in Melanesian adults and children in Solomon Islands and Vanuatu.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard dose
Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, and will be administered the standard recommended primaquine dose of 0.25mg/kg for 14 consecutive days.
Primaquine
High dose
Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, and will be administered a primaquine dose of 0.5mg/kg/day for 14 consecutive days.
Primaquine
Control
Participants will receive a standard 3-day treatment course of artemether-lumefantrine at the standard age-based dosage, but will not receive primaquine until the time of confirmed recurrent parasitaemia or completion of 3 months follow up.
delayed primaquine
Interventions
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Primaquine
delayed primaquine
Eligibility Criteria
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Inclusion Criteria
2. Melanesian background and living in local area
3. Microscopically (based on field microscopy) or RDT confirmed P.vivax regardless of parasite density. Mixed infections (P.falciparum-P.vivax and P.malariae-P.vivax) can be included.
Exclusion Criteria
2. Clinical evidence of non-malarial illness (such as pneumonia or otitis media)
3. Severe malnutrition (weight-for-age nutritional Z score \[WAZ\] \<60th percentile)
4. Permanent disability, which prevents or impedes study participation.
5. Treatment with primaquine in the previous 14 days
6. Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures)
7. Known or suspected pregnancy
8. Currently breastfeeding
9. A positive rapid test for G6PD deficiency (Binax or Carestart RDT)
Following later PCR-based confirmation of malaria speciation, there may be some post-hoc exclusion of subjects in whom it is thought the initial field-based microscopic diagnosis may have been incorrect.
12 Months
60 Years
ALL
No
Sponsors
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Walter and Eliza Hall Institute of Medical Research
OTHER
Ministry of Health, Vanuatu
OTHER_GOV
Ministry of Health, Solomon Islands
OTHER_GOV
World Health Organization
OTHER
Menzies School of Health Research
OTHER
Responsible Party
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Locations
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Tetere Hospital, Guadalcanal Province
Honiara, Guadalcanal Province, Solomon Islands
Aoki Hospital, Malaita Province
Auki, Malaita Province, Solomon Islands
Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary
Luganville, Sanma, Vanuatu
Toroa Dispensary, NTM Health Centre and Vila Central Hospital
Port Vila, Shefa Province, Vanuatu
Countries
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Central Contacts
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Facility Contacts
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Lyndes Wini
Role: primary
Albino Bobogare
Role: backup
Albino Bobogare
Role: primary
Lyndes Wini
Role: backup
George Taleo
Role: primary
Edward Tambisari
Role: backup
George Taleo
Role: primary
Edward Tambisari, MD
Role: backup
Other Identifiers
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VanSI_2013
Identifier Type: -
Identifier Source: org_study_id