MalariaNCT01837992
Safety and Efficacy of Primaquine for P. Vivax
A study testing Primaquine and delayed primaquine in people with Malaria, run by Menzies School of Health Research at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 12 months to 60 years
- Conditions the study is for
- Malaria
- What is being tested?
- Primaquine and delayed primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Solomon Islands2 sites
Aoki Hospital, Malaita Province
Auki, Malaita Province
Albino Bobogare
Lyndes Wini
Tetere Hospital, Guadalcanal Province
Honiara, Guadalcanal Province
Lyndes Wini
Albino Bobogare
Vanuatu2 sites
Northern Provincial Hospital, Nambauk Aid Post, V.F.H.A Dispensary and Fanafo Dispensary
Luganville, Sanma
George Taleo
Edward Tambisari
Toroa Dispensary, NTM Health Centre and Vila Central Hospital
Port Vila, Shefa
George Taleo
Edward Tambisari, MD
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Primaquine, delayed primaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimaquineDrug
delayed primaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard dose | Active comparator | 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. Receives: Drug: Primaquine |
| High dose | Active comparator | 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. Receives: Drug: Primaquine |
| Control | Other | 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. Receives: Drug: delayed primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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).
Measured: 12 months
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).
Measured: 12 months
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).
Measured: 12 months
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).
Measured: 12 months
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
Measured: 12 months
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%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Walter and Eliza Hall Institute of Medical Research, Ministry of Health, Vanuatu, Ministry of Health, Solomon Islands, World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837992
- Sponsor's protocol ID
- VanSI_2013
- Status last verified
- Nov 2013
- First submitted
- 25 Mar 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01837992
- Acronym / sponsor ID
- VanSI_2013
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Walter and Eliza Hall Institute of Medical Research, Ministry of Health, Vanuatu, Ministry of Health, Solomon Islands, World Health Organization
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dose | Active comparator | Drug: PrimaquineParticipants 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. |
| High dose | Active comparator | Drug: PrimaquineParticipants 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. |
| Control | Other | Drug: delayed primaquineParticipants 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. |
Who may qualify
- Ages
- 12 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primaquine | Drug | High dose, Standard dose |
| delayed primaquine | Drug | Control |
Primary outcome
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.
6 secondary outcomes
Safety and toxicity (1): Numbers with mild adverse events
Time frame: 12 months
Safety and toxicity (2) Numbers with moderate adverse events
Time frame: 12 months
Safety and toxicity (3) Numbers with severe adverse events
Time frame: 12 months
Safety and toxicity (4) Numbers with any adverse events
Time frame: 12 months
Safety and toxicity (5) Numbers with assumed significant haemolysis
Time frame: 12 months
Safety and toxicity (6) Numbers with significant methaemoglobinaemia
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primaquine and delayed primaquine in people with Malaria, run by Menzies School of Health Research at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Solomon Islands, Vanuatu. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivo Mueller, PhD (+61 3 9345 2555, mueller@wehi.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Numbers of Plasmodium vivax relapses per person-years of follow- (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.