Malaria, VivaxSSATNCT04223674
Serological Screen and Treat Trial for Plasmodium Vivax
A study testing Serological screen and treat in people with Malaria, Vivax, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This is a clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to evaluate the efficacy of serological screening vs. routine care for the prevention of recurrent P. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Vivax
- What is being tested?
- Serological screen and treat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,133 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Feb 2022to 30 Dec 2023
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- resident of study area and attending selected elementary school in Grade 1-5 or middle school Grade 1-3
- no evidence of health condition that would interfere with study participation
- assent of child and documented parental informed consent
Who cannot join
- G6PD deficiency as determined by SD Biosensor quantitative determination of <70% G6PD activity (<6 U/g Hb).
- Haemoglobin < 9 g/dL
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Tanjung Tiram Primary Health Center
Tanjung Tiram, Batubara, 21253
About this study
Official title: Serological Screen and Treat Trial for P. Vivax: a Proof-of-concept Trial in Western Indonesia
This is a clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to evaluate the efficacy of serological screening vs. routine care for the prevention of recurrent P. vivax infections. A total of 960 schoolchildren will be randomized into the interventional or control arm.
Read the detailed description
This is a randomized controlled trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to show a superiority of SSAT vs. routine care for the prevention of recurrent P. vivax infections. With the estimated prevalence of 20%, the investigators will have a power of >90% to detect a significant difference with the sample size of 350 children per group. The investigators will recruit 480 children per group to anticipate subject loss due to exclusion and drop out.
After obtaining informed consent from their parents/legal guardians, 800 schoolchildren living in Batubara regency, North Sumatra, Indonesia, will be individually randomized to intervention (SSAT) or control (routine care) group. During enrollment, all participants will be tested with Pv serological test by standard Luminex, and standard finger stick microscopic. Their hemoglobin (Hb) and Glucose-6-Phosphate Dehydrogenase (G6PD) level will be measured. Children with Hb level<9 g/dL and/or G6PD <4 U/g Hb (male) or <6 U/g Hb (female) will be excluded. In the intervention arm (SSAT), children who are seropositive by standard Luminex and/or symptomatic LMF positive will be treated with dihydroartemisinin-piperaquine (DHA-PP) for 3 days according to national guideline and primaquine/PQ high dose (1 mg/kg BW/day for 7 days for Pv/Po, 0.25 mg/kg BW for Pf). In the control arm, children will be treated only when they show symptoms (body temperature>=36.5oC or history of fever within last 3 days) and proven positive by LMF. All treatment will be provided under direct supervision by the research team during which any adverse event/severe adverse event will be recorded. Hemoglobin level and urine will be monitored daily for 7 days of PQ administration. Post-hoc qPCR detection will be performed to determine their initial malaria status. Several additional tests will also be performed to all participants during this initial screening: microscopic examination of shallow vasculature of the ankle (light microscopy-skin/LMS), magneto-optical detection of hemozoin, and post-hoc point-of-care/POC serological test.
After enrollment, all children will be actively followed for 9 months every 4 weeks for post-hoc assessment by qPCR. Anytime during this follow up period, children becoming acutely ill will be tested for malaria by LMF, and referred to Primary Health Center to receive treatment when positive. Furthermore, household members of these infected children will also be screened for malaria infection by LMF and post-hoc LMS and qPCR. This family screening will be performed by 2x house visit (7-10 AM and 7-10 PM). Treatment will be given for those found positive by LMF regardless of their symptoms. Antimalarial treatment provided during this follow up period will be according to national standard guideline: 3 days of DHA-PP plus PQ (single 0.25 mg/kg BW dose for Pf, daily 0.25 mg/kg BW dose for 14 days for Pv/Po).
At the end of study, Pv serological test and LMF will be performed to all schoolchildren. Those found positive by LMF will be referred to Primary Health Center to receive treatment according to national standard guideline.
Sponsor: WEHI, Funding: NHMRC, Grant number: GNT1102297
- Conditions
- Malaria, Vivax
- Being tested
- Serological screen and treat
- Keywords
- serology, screen, treat, recurrent, vivax
- Medical subject headings
- Malaria, Vivax, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological screen and treatDiagnostic test
Multi-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment
| Study group | Role | What they receive |
|---|---|---|
| Serological screen and treat | Experimental | Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided for those with Pv seropositive regardless of their symptoms and symptomatic children with microscopic Pv/Po positive. Receives: Diagnostic Test: Serological screen and treat |
| Routine care | No intervention | Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided only for symptomatic children with microscopic Pv/Po positive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence reduction
Difference of P. vivax incidence by PCR between children serologically screened and those receiving routine care.
Measured: 9 month of follow up
Secondary outcomes (10)
Time-to recur
Difference in the time-to recur of P. vivax by PCR in SSAT and control arms.
Measured: 9 month
Recurrence number
Difference in the number of recurrent P. vivax by PCR in SSAT vs. control arms
Measured: 9 month
Recurrent symptomatic P. vivax
Difference in the incidence of recurrent symptomatic P. vivax by microscopy in SSAT vs control arms
Measured: 9 month
Seroconversion rate
Seroconversion rate before and after intervention in SSAT and control arms.
Measured: 9 month
point-of-care assay performance
Sensitivity and specificity of point-of-care antibody detection test vs. gold standard Luminex assay
Measured: one month
Adverse event and severe adverse event
Adverse event (AE) and Severe Adverse Event (SAE) of high dose PQ in schoolchildren.
Measured: 9 month
Sahli Hb
Hb level in Sahli's method, Standard G6PD (SD Biosensor Inc., ROK) in comparison with (HemoCue AB, Angelholm, Sweden).
Measured: One month
Skin gametocyte
Sensitivity and specificity of microscopic examination to detect parasitemia from the shallow skin vasculature of the ankle (light microscopy-skin/LMS) compared to standard microscopic (light microscopy-finger/LMF) and PCR.
Measured: 9 month
Gametocyte duration
Mean duration time of gametocyte in LMS and LMF
Measured: 9 month
Hemozoin detection
Sensitivity and specificity of magneto-optical hemozoin detection (MOD) compared to standard malaria detection and PCR.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start9 Feb 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, VivaxStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study evaluates an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. 960 children living in western Indonesia will be individually randomised to the experimental serologic test or routine care. Children in the serological diagnosis arm will be screened for the presence of antibodies to a previously validated panel of malaria antigens optimized for sensitivity to infection during the prior 9 months. Furthermore, they also will be screened by microscopy. If positive by either test, they will be treated for that malaria infection. Children assigned to routine care will be screened by microscopic examination and treated when they show or have history of symptoms in the last 3 days. After initial screening and treating according to diagnostic technique, all children will be actively followed for 9 months with PCR detection every 4 weeks.
- Masking
- None (open label)
- Enrolment
- 1,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Eijkman Institute for Molecular Biology, Oxford University Clinical Research Unit Indonesia, Walter and Eliza Hall Institute of Medical Research, Rumah Sakit Umum Daerah Mimika, Universitas Sumatera Utara
- Responsible party
- Principal investigator, Inge Sutanto, Universitas Indonesia
- Investigators
- Inge Sutanto, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223674
- Sponsor's protocol ID
- 19-09-1129
- Acronym
- SSAT
- Status last verified
- Mar 2023
- First submitted
- 3 Jan 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data that will be shared: Only fully anonymized data sets will be shared as required for transparency and to fulfil publication requirements. Who will have access to the data: Researcher who provide a methodologically sound proposal. Where will the data be available: The data will be available upon request. When will the data be shared: Immediately following publication. No end date. How will researchers locate and access the data: Proposal should be sent to akosasih@eocru.org as the Study Coordinator of the trial. To gain access, data requestor will need to sign data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Screen and Treat Trial for P. Vivax: a Proof-of-concept Trial in Western Indonesia
- ClinicalTrials.gov ID
- NCT04223674
- Acronym / sponsor ID
- SSAT / 19-09-1129
- Conditions
- Malaria, Vivax
- Keywords
- serology, screen, treat, recurrent, vivax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,133 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Eijkman Institute for Molecular Biology, Oxford University Clinical Research Unit Indonesia, Walter and Eliza Hall Institute of Medical Research, Rumah Sakit Umum Daerah Mimika, Universitas Sumatera Utara
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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 clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to evaluate the efficacy of serological screening vs. routine care for the prevention of recurrent P. vivax infections. A total of 960 schoolchildren will be randomized into the interventional or control arm.
Detailed description
This is a randomized controlled trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. The study is designed to show a superiority of SSAT vs. routine care for the prevention of recurrent P. vivax infections. With the estimated prevalence of 20%, the investigators will have a power of >90% to detect a significant difference with the sample size of 350 children per group. The investigators will recruit 480 children per group to anticipate subject loss due to exclusion and drop out.
After obtaining informed consent from their parents/legal guardians, 800 schoolchildren living in Batubara regency, North Sumatra, Indonesia, will be individually randomized to intervention (SSAT) or control (routine care) group. During enrollment, all participants will be tested with Pv serological test by standard Luminex, and standard finger stick microscopic. Their hemoglobin (Hb) and Glucose-6-Phosphate Dehydrogenase (G6PD) level will be measured. Children with Hb level<9 g/dL and/or G6PD <4 U/g Hb (male) or <6 U/g Hb (female) will be excluded. In the intervention arm (SSAT), children who are seropositive by standard Luminex and/or symptomatic LMF positive will be treated with dihydroartemisinin-piperaquine (DHA-PP) for 3 days according to national guideline and primaquine/PQ high dose (1 mg/kg BW/day for 7 days for Pv/Po, 0.25 mg/kg BW for Pf). In the control arm, children will be treated only when they show symptoms (body temperature>=36.5oC or history of fever within last 3 days) and proven positive by LMF. All treatment will be provided under direct supervision by the research team during which any adverse event/severe adverse event will be recorded. Hemoglobin level and urine will be monitored daily for 7 days of PQ administration. Post-hoc qPCR detection will be performed to determine their initial malaria status. Several additional tests will also be performed to all participants during this initial screening: microscopic examination of shallow vasculature of the ankle (light microscopy-skin/LMS), magneto-optical detection of hemozoin, and post-hoc point-of-care/POC serological test.
After enrollment, all children will be actively followed for 9 months every 4 weeks for post-hoc assessment by qPCR. Anytime during this follow up period, children becoming acutely ill will be tested for malaria by LMF, and referred to Primary Health Center to receive treatment when positive. Furthermore, household members of these infected children will also be screened for malaria infection by LMF and post-hoc LMS and qPCR. This family screening will be performed by 2x house visit (7-10 AM and 7-10 PM). Treatment will be given for those found positive by LMF regardless of their symptoms. Antimalarial treatment provided during this follow up period will be according to national standard guideline: 3 days of DHA-PP plus PQ (single 0.25 mg/kg BW dose for Pf, daily 0.25 mg/kg BW dose for 14 days for Pv/Po).
At the end of study, Pv serological test and LMF will be performed to all schoolchildren. Those found positive by LMF will be referred to Primary Health Center to receive treatment according to national standard guideline.
Sponsor: WEHI, Funding: NHMRC, Grant number: GNT1102297
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study evaluates an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver. 960 children living in western Indonesia will be individually randomised to the experimental serologic test or routine care. Children in the serological diagnosis arm will be screened for the presence of antibodies to a previously validated panel of malaria antigens optimized for sensitivity to infection during the prior 9 months. Furthermore, they also will be screened by microscopy. If positive by either test, they will be treated for that malaria infection. Children assigned to routine care will be screened by microscopic examination and treated when they show or have history of symptoms in the last 3 days. After initial screening and treating according to diagnostic technique, all children will be actively followed for 9 months with PCR detection every 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Serological screen and treat | Experimental | Diagnostic Test: Serological screen and treatChildren who screened with sero test and microscopy. A 7-day high dose PQ will be provided for those with Pv seropositive regardless of their symptoms and symptomatic children with microscopic Pv/Po positive. |
| Routine care | No intervention | –Children who screened with sero test and microscopy. A 7-day high dose PQ will be provided only for symptomatic children with microscopic Pv/Po positive. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- resident of study area and attending selected elementary school in Grade 1-5 or middle school Grade 1-3
- no evidence of health condition that would interfere with study participation
- assent of child and documented parental informed consent
Key exclusion criteria (2 listed)
- G6PD deficiency as determined by SD Biosensor quantitative determination of <70% G6PD activity (<6 U/g Hb).
- Haemoglobin < 9 g/dL
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 |
|---|---|---|
| Serological screen and treatMulti-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment | Diagnostic test | Serological screen and treat |
Primary outcome
Incidence reduction
Time frame: 9 month of follow up
Difference of P. vivax incidence by PCR between children serologically screened and those receiving routine care.
10 secondary outcomes
Time-to recur
Time frame: 9 month
Recurrence number
Time frame: 9 month
Recurrent symptomatic P. vivax
Time frame: 9 month
Seroconversion rate
Time frame: 9 month
point-of-care assay performance
Time frame: one month
Adverse event and severe adverse event
Time frame: 9 month
Sahli Hb
Time frame: One month
Skin gametocyte
Time frame: 9 month
Gametocyte duration
Time frame: 9 month
Hemozoin detection
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Yes. What data that will be shared: Only fully anonymized data sets will be shared as required for transparency and to fulfil publication requirements. Who will have access to the data: Researcher who provide a methodologically sound proposal. Where will the data be available: The data will be available upon request. When will the data be shared: Immediately following publication. No end date. How will researchers locate and access the data: Proposal should be sent to akosasih@eocru.org as the Study Coordinator of the trial. To gain access, data requestor will need to sign data access agreement.
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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.
Inge Sutanto, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serological screen and treat in people with Malaria, Vivax, run by Universitas Indonesia 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 3 inclusion and 2 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 7 Mar 2023. 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.
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?
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?
Incidence reduction (time frame: 9 month of follow up). 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 7 Mar 2023.