Uncomplicated MalariaPhase 4TRIPINCT02787070
A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)
A Phase 4 study testing PQ supervised and PQ unsupervised in people with Uncomplicated Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
Trial summary
Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after both P. vivax and P. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- PQ supervised and PQ unsupervised
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Sep 2016to Nov 2018
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infection with Plasmodium falciparum or P. vivax either alone or mixed
- Age >12 months
- Weight >5kg
- Living in the study clusters
Who cannot join
- General danger signs or symptoms of severe malaria
- Anaemia, defined as Hb <9g/dl
- G6PD deficiency (as determined by FST)
- Pregnant women as determined by Urine β-HCG pregnancy test
- Known hypersensitivity to any of the drugs given
Trial locations and contacts
1 site in 1 country.
About this study
Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen. In Papua a retrospective study found very low effectiveness for unsupervised treatment. If true this has profound effects on treatment policy, suggesting that greater efforts are needed to encourage adherence to treatment.
We propose a cluster randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. Since the risk of recurrent P. vivax is high in patients with either P. vivax or P. falciparum, both infections will be included in the study. The study will be conducted in Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at village health posts and provided with schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised depending on which cluster the clinic is in. Participants will be followed up for 6 months and assessed in 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
- Uncomplicated Malaria
- Being tested
- PQ supervised, PQ unsupervised
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PQ supervisedDrug
PQ unsupervisedDrug
| Study group | Role | What they receive |
|---|---|---|
| Primaquine supervised | Active comparator | 14 days of supervised primaquine treatment (0.5mg/kg/day). Receives: Drug: PQ supervised |
| Primaquine unsupervised | Active comparator | 14 days of unsupervised primaquine treatment (0.5mg/kg/day). Receives: Drug: PQ unsupervised |
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 6 months in patients enrolled with any malaria infection
Measured: 6 months
Secondary outcomes (12)
The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria infection
Measured: 6 months
The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria infection
Measured: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with malaria due to P. falciparum or P. vivax
Measured: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria
Measured: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria
Measured: 6 months
The incidence risk of patent or sub-microscopic P. vivax malaria over six months in patients enrolled with a malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)
Measured: 6 months
The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over six months in patients
Measured: 6 months
The proportion of patients vomiting their medication within 1 hour of administration
Measured: 1 hour
• The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course
Measured: 14 days
• The proportion of adverse events and serious adverse events over 6 months in all patients
Measured: 6 months
• The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 6 months
Measured: 6 months
• The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start14 Sep 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787070
- Sponsor's protocol ID
- TRIPI
- Acronym
- TRIPI
- Status last verified
- Apr 2019
- First submitted
- 26 May 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Poespoprodjo JR, Burdam FH, Candrawati F, Ley B, Meagher N, Kenangalem E, Indrawanti R, Trianty L, Thriemer K, Price DJ, Simpson JA, Price RN. Supervised versus unsupervised primaquine radical cure for the treatment of falciparum and vivax malaria in Papua, Indonesia: a cluster-randomised, controlled, open-label superiority trial. Lancet Infect Dis. 2022 Mar;22(3):367-376. doi: 10.1016/S1473-3099(21)00358-3. Epub 2021 Oct 25.
PubMed 34710363
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)
- ClinicalTrials.gov ID
- NCT02787070
- Acronym / sponsor ID
- TRIPI / TRIPI
- Conditions
- Uncomplicated Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 1 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.
Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen. In Papua a retrospective study found very low effectiveness for unsupervised treatment. If true this has profound effects on treatment policy, suggesting that greater efforts are needed to encourage adherence to treatment.
We propose a cluster randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. Since the risk of recurrent P. vivax is high in patients with either P. vivax or P. falciparum, both infections will be included in the study. The study will be conducted in Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at village health posts and provided with schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised depending on which cluster the clinic is in. Participants will be followed up for 6 months and assessed in 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 |
|---|---|---|
| Primaquine supervised | Active comparator | Drug: PQ supervised14 days of supervised primaquine treatment (0.5mg/kg/day). |
| Primaquine unsupervised | Active comparator | Drug: PQ unsupervised14 days of unsupervised primaquine treatment (0.5mg/kg/day). |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infection with Plasmodium falciparum or P. vivax either alone or mixed
- Age >12 months
- Weight >5kg
- Living in the study clusters
Key exclusion criteria (5 listed)
- General danger signs or symptoms of severe malaria
- Anaemia, defined as Hb <9g/dl
- G6PD deficiency (as determined by FST)
- Pregnant women as determined by Urine β-HCG pregnancy test
- 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 |
|---|---|---|
| PQ supervised | Drug | Primaquine supervised |
| PQ unsupervised | Drug | Primaquine unsupervised |
Primary outcome
The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with any malaria infection
Time frame: 6 months
12 secondary outcomes
The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria infection
Time frame: 6 months
The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria infection
Time frame: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with malaria due to P. falciparum or P. vivax
Time frame: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria
Time frame: 6 months
The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria
Time frame: 6 months
The incidence risk of patent or sub-microscopic P. vivax malaria over six months in patients enrolled with a malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)
Time frame: 6 months
The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over six months in patients
Time frame: 6 months
The proportion of patients vomiting their medication within 1 hour of administration
Time frame: 1 hour
• The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course
Time frame: 14 days
• The proportion of adverse events and serious adverse events over 6 months in all patients
Time frame: 6 months
• The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 6 months
Time frame: 6 months
• The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 34710363Poespoprodjo JR, Burdam FH, Candrawati F, Ley B, Meagher N, Kenangalem E, Indrawanti R, Trianty L, Thriemer K, Price DJ, Simpson JA, Price RN. Supervised versus unsupervised primaquine radical cure for the treatment of falciparum and vivax malaria in Papua, Indonesia: a cluster-randomised, controlled, open-label superiority trial. Lancet Infect Dis. 2022 Mar;22(3):367-376. doi: 10.1016/S1473-3099(21)00358-3. Epub 2021 Oct 25.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PQ supervised and PQ unsupervised in people with Uncomplicated Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 6 months in patients enrolled with any malaria infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787070, which also lists 1 linked publication.
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 16 Apr 2019.