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Trial record 3 of 4 for:    Solomon | Solomon Islands

Safety and Efficacy of Primaquine for P. Vivax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837992
Recruitment Status : Unknown
Verified November 2013 by Menzies School of Health Research.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2013
Last Update Posted : November 8, 2013
Sponsor:
Collaborators:
Walter and Eliza Hall Institute of Medical Research
Ministry of Health, Vanuatu
Ministry of Health, Solomon Islands
World Health Organization
Information provided by (Responsible Party):
Menzies School of Health Research

Tracking Information
First Submitted Date  ICMJE March 25, 2013
First Posted Date  ICMJE April 23, 2013
Last Update Posted Date November 8, 2013
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
Efficacy: Numbers of Plasmodium vivax relapses per person-years of follow- [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01837992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Safety and toxicity (1): Numbers with mild adverse events [ Time Frame: 12 months ]
    Numbers in each treatment arm experiencing any documented adverse event defined as "mild" (not severe enough to interfere with daily activities).
  • Safety and toxicity (2) Numbers with moderate adverse events [ Time Frame: 12 months ]
    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).
  • Safety and toxicity (3) Numbers with severe adverse events [ Time Frame: 12 months ]
    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).
  • Safety and toxicity (4) Numbers with any adverse events [ Time Frame: 12 months ]
    Numbers in each treatment arm experiencing any documented event (defined as either mild, moderate or severe as above).
  • Safety and toxicity (5) Numbers with assumed significant haemolysis [ Time Frame: 12 months ]
    Numbers in each treatment arm experiencing any of the following:
    1. Haemoglobinuria on dipstick examination
    2. Scleral icterus
    3. Haemoglobin concentration fall by more than 25% of baseline or absolute concentration <5g/dL
  • Safety and toxicity (6) Numbers with significant methaemoglobinaemia [ Time Frame: 12 months ]
    Numbers in each treatment arm experiencing any of the following:
    1. Cyanosis (blue tongue, lips and peripheries)
    2. Measured methaemoglobin saturation (using Masimo Rad-57 plus oximeter) >15%
    3. Measured oxygen saturation <85%
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Primaquine for P. Vivax
Official Title  ICMJE Evaluation of Safety and Efficacy of Two Primaquine Dosing Regimens for the Radical Treatment of Plasmodium Vivax Malaria in Vanuatu and Solomon Islands
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 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE
  • Drug: Primaquine
  • Drug: delayed primaquine
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: Primaquine
  • Active Comparator: 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.
    Intervention: Drug: 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.
    Intervention: Drug: delayed primaquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Solomon Islands,   Vanuatu
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837992
Other Study ID Numbers  ICMJE VanSI_2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menzies School of Health Research
Study Sponsor  ICMJE Menzies School of Health Research
Collaborators  ICMJE
  • Walter and Eliza Hall Institute of Medical Research
  • Ministry of Health, Vanuatu
  • Ministry of Health, Solomon Islands
  • World Health Organization
Investigators  ICMJE Not Provided
PRS Account Menzies School of Health Research
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP