MalariaPhase 4SPRUENCT02793388
A Trial on Supervised Primaquine Use in Ethiopia
A Phase 4 study testing Supervised primaquine treatment and Unsupervised primaquine treatment in people with Malaria, run by Menzies School of Health Research.
Trial summary
This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- Supervised primaquine treatment and Unsupervised primaquine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Age >5 years
- Weight >5kg
- Written informed consent
- Living in the study area and willing to be followed for 4 months
Who cannot join
- General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)
- Anaemia, defined as Hb <8g/dl
- Pregnant women as determined by Urine β-HCG pregnancy test
- Breast feeding women
- Known hypersensitivity to any of the drugs given
- Living in the same household as an individual enrolled into the study in the last 14 days
About this study
Official title: A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia
This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.
- Conditions
- Malaria
- Being tested
- Supervised primaquine treatment, Unsupervised primaquine treatment
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised primaquine treatmentDrug
Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day.
Unsupervised primaquine treatmentDrug
Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised.
| Study group | Role | What they receive |
|---|---|---|
| Supervised primaquine arm | Active comparator | Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure. Supervision of primaquine is done on alternate days at home (attended by a home visitor) or at the health centre. Receives: Drug: Supervised primaquine treatment |
| Unsupervised primaquine arm | Active comparator | Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure for self administration. Receives: Drug: Unsupervised primaquine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
Measured: 4 months
Secondary outcomes (9)
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.
Measured: 4 months
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.
Measured: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax.
Measured: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.
Measured: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.
Measured: 4 months
The incidence risk of patent or sub-microscopic P. vivax malaria over 4 months in patients enrolled with malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)
Measured: 4 months
The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients
Measured: 4 months
The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted
Measured: 1 year
Socio-economic factors for adherence to primaquine treatment
Factors are collected through a semi-standardized questionaire. Factors include indicators for economic status, as well as information on educational background.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793388
- Sponsor's protocol ID
- HREC 2016-2620
- Acronym
- SPRUE
- Status last verified
- Feb 2017
- First submitted
- 26 May 2016
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia
- ClinicalTrials.gov ID
- NCT02793388
- Acronym / sponsor ID
- SPRUE / HREC 2016-2620
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Jun 2016 (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.
This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised primaquine arm | Active comparator | Drug: Supervised primaquine treatmentFollowing standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure. Supervision of primaquine is done on alternate days at home (attended by a home visitor) or at the health centre. |
| Unsupervised primaquine arm | Active comparator | Drug: Unsupervised primaquine treatmentFollowing standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure for self administration. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- Age >5 years
- Weight >5kg
- Written informed consent
- Living in the study area and willing to be followed for 4 months
Key exclusion criteria (6 listed)
- General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)
- Anaemia, defined as Hb <8g/dl
- Pregnant women as determined by Urine β-HCG pregnancy test
- Breast feeding women
- Known hypersensitivity to any of the drugs given
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 |
|---|---|---|
| Supervised primaquine treatmentFollowing schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day. | Drug | Supervised primaquine arm |
| Unsupervised primaquine treatmentFollowing schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised. | Drug | Unsupervised primaquine arm |
Primary outcome
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
Time frame: 4 months
9 secondary outcomes
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.
Time frame: 4 months
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.
Time frame: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax.
Time frame: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.
Time frame: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.
Time frame: 4 months
The incidence risk of patent or sub-microscopic P. vivax malaria over 4 months in patients enrolled with malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)
Time frame: 4 months
The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients
Time frame: 4 months
The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted
Time frame: 1 year
Socio-economic factors for adherence to primaquine treatment
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supervised primaquine treatment and Unsupervised primaquine treatment in people with Malaria, run by Menzies School of Health Research.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria. (time frame: 4 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 Feb 2017.