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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01837992
Other study ID # VanSI_2013
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 25, 2013
Last updated November 7, 2013
Start date May 2013
Est. completion date May 2015

Study information

Verified date November 2013
Source Menzies School of Health Research
Contact Ivo Mueller, PhD
Phone +61 3 9345 2555
Email mueller@wehi.edu.au
Is FDA regulated No
Health authority Australia: Menzies School of Health ResearchAustralia: Walter and Eliza Hall InstituteAustralia: Western HealthVanuatu: Ministry of HealthVanuatu: World Health OrganizationSolomon Islands: Ministry of HealthSolomon Islands: World Health OrganizationPhilippines: World Health Organization
Study type Interventional

Clinical Trial 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 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.


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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date May 2015
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 60 Years
Eligibility Inclusion Criteria:

1. Age 12 months to 60 years

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:

1. 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Primaquine

delayed primaquine


Locations

Country Name City State
Solomon Islands Aoki Hospital, Malaita Province Auki Malaita Province
Solomon Islands Tetere Hospital, Guadalcanal Province Honiara Guadalcanal Province
Vanuatu Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary Luganville Sanma Province
Vanuatu Toroa Dispensary, NTM Health Centre and Vila Central Hospital Port Vila Shefa Province

Sponsors (5)

Lead Sponsor Collaborator
Menzies School of Health Research Ministry of Health, Solomon Islands, Ministry of Health, Vanuatu, Walter and Eliza Hall Institute of Medical Research, World Health Organization

Countries where clinical trial is conducted

Solomon Islands,  Vanuatu, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Numbers of Plasmodium vivax relapses per person-years of follow- Total number of microscopically diagnosed (including both symptomatic and asymptomatic infections), PCR-confirmed relapses with Plasmodium vivax in participants in each treatment arm over the 3-month follow-up period, expressed as number of relapses per person-years of follow-up. 12 months No
Secondary Safety and toxicity (1): Numbers with mild adverse events Numbers in each treatment arm experiencing any documented adverse event defined as "mild" (not severe enough to interfere with daily activities). 12 months Yes
Secondary Safety and toxicity (2) Numbers with moderate adverse events Numbers in each treatment arm experiencing any documented adverse event defined as "moderate" (severe enough to interfere with daily activities but not severe enough to warrant admission to hospital). 12 months Yes
Secondary Safety and toxicity (3) Numbers with severe adverse events Numbers in each treatment arm experiencing any documented adverse event defined as "severe" (severe to warrant admission to hospital or to be considered a risk for death or disability arising from the event). 12 months Yes
Secondary Safety and toxicity (4) Numbers with any adverse events Numbers in each treatment arm experiencing any documented event (defined as either mild, moderate or severe as above). 12 months Yes
Secondary Safety and toxicity (5) Numbers with assumed significant haemolysis Numbers in each treatment arm experiencing any of the following:
Haemoglobinuria on dipstick examination
Scleral icterus
Haemoglobin concentration fall by more than 25% of baseline or absolute concentration <5g/dL
12 months Yes
Secondary Safety and toxicity (6) Numbers with significant methaemoglobinaemia Numbers in each treatment arm experiencing any of the following:
Cyanosis (blue tongue, lips and peripheries)
Measured methaemoglobin saturation (using Masimo Rad-57 plus oximeter) >15%
Measured oxygen saturation <85%
12 months Yes
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