Status:
UNKNOWN
Safety and Efficacy of Primaquine for P. Vivax
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Walter and Eliza Hall Institute of Medical Research
Ministry of Health, Vanuatu
Conditions:
Malaria
Eligibility:
All Genders
12-60 years
Phase:
NA
Brief Summary
The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu) represent a unique and especially prescient challenge to malaria control and elimination. While the use of...
Detailed Description
Study Aims 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...
Eligibility Criteria
Inclusion
- Age 12 months to 60 years
- Melanesian background and living in local area
- 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
- Any signs of severe malaria (see WHO definitions) including: impaired consciousness, respiratory distress, severe anaemia (Hb\<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia.
- Clinical evidence of non-malarial illness (such as pneumonia or otitis media)
- Severe malnutrition (weight-for-age nutritional Z score \[WAZ\] \<60th percentile)
- Permanent disability, which prevents or impedes study participation.
- Treatment with primaquine in the previous 14 days
- Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures)
- Known or suspected pregnancy
- Currently breastfeeding
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01837992
Start Date
May 1 2013
End Date
May 1 2015
Last Update
November 8 2013
Active Locations (4)
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1
Tetere Hospital, Guadalcanal Province
Honiara, Guadalcanal Province, Solomon Islands
2
Aoki Hospital, Malaita Province
Auki, Malaita Province, Solomon Islands
3
Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary
Luganville, Sanma, Vanuatu
4
Toroa Dispensary, NTM Health Centre and Vila Central Hospital
Port Vila, Shefa Province, Vanuatu