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Trial record 3 of 4 for:    Solomon | Solomon Islands

Safety and Efficacy of Primaquine for P. Vivax

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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

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.


Condition or disease Intervention/treatment Phase
Malaria Drug: Primaquine Drug: delayed primaquine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Two Primaquine Dosing Regimens for the Radical Treatment of Plasmodium Vivax Malaria in Vanuatu and Solomon Islands
Study Start Date : May 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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.
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.
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.
Drug: delayed primaquine



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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

  6. 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%



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Ages Eligible for Study:   12 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837992


Contacts
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Contact: Ivo Mueller, PhD +61 3 9345 2555 mueller@wehi.edu.au

Locations
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Solomon Islands
Tetere Hospital, Guadalcanal Province Not yet recruiting
Honiara, Guadalcanal Province, Solomon Islands
Contact: Lyndes Wini         
Contact: Albino Bobogare         
Aoki Hospital, Malaita Province Not yet recruiting
Auki, Malaita Province, Solomon Islands
Contact: Albino Bobogare         
Contact: Lyndes Wini         
Vanuatu
Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary Not yet recruiting
Luganville, Sanma Province, Vanuatu
Contact: George Taleo         
Contact: Edward Tambisari         
Toroa Dispensary, NTM Health Centre and Vila Central Hospital Not yet recruiting
Port Vila, Shefa Province, Vanuatu
Contact: George Taleo         
Contact: Edward Tambisari, MD         
Sponsors and Collaborators
Menzies School of Health Research
Walter and Eliza Hall Institute of Medical Research
Ministry of Health, Vanuatu
Ministry of Health, Solomon Islands
World Health Organization

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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT01837992     History of Changes
Other Study ID Numbers: VanSI_2013
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents