Malaria, VivaxSeverePVNCT03307369
A Retrospective Study of Severe Plasmodium Vivax
An observational study of Malaria, Vivax, run by University of Oxford at 1 site in Thailand.
Trial summary
Historically, Plasmodium vivax has been termed "benign" due to its non-life threatening clinical course and since the 1800's this view has been cultivated as demonstrated by the use of the term "benign tertian malaria" to describe the infection.However over the last 15 years, more severe P. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria, Vivax
- How many people
- 171 participants
- Where
- 1 siteThailand
- Study dates
- 27 Oct 2017to 15 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The retrospective data from approximately 600 P.vivax infected patients who have had routine clinical work performed in the outpatient and inpatient departments at SMRU during 2001-2016. The patient population consists of refugees and migrants living along the Thailand Myanmar border in north-western Thailand who seek health care at the SMRU hospitals.
Who may be able to join
- Patients voluntarily presented at SMRU clinic during 2001-2016 with a diagnosis of P. vivax mono-infection
Who cannot join
- Patients voluntarily presented at SMRU clinic during 2001-2016 with fever and were seeking consultation for the treatment of malaria or other infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study to Assess the Rate of Plasmodium Vivax Infections Presenting With Severe Symptoms From 2001 to 2016 in North-western Thailand
Historically, Plasmodium vivax has been termed "benign" due to its non-life threatening clinical course and since the 1800's this view has been cultivated as demonstrated by the use of the term "benign tertian malaria" to describe the infection.However over the last 15 years, more severe P. vivax malaria is being reported, causing concern that severe P. vivax malaria is under diagnosed. The definition of severe P. vivax malaria borrows from P. falciparum and is primarily one of exclusion. Species PCR (polymerase chain reaction) is the only way to prove P. vivax mono-infection but is expensive and requires skilled staff and technology. In resource constrained settings, diagnostic testing is not available for detection of most non-malarial infections further affecting the ability to determine whether severe symptoms are due to P. vivax malarial infection or a concomitant one.
Retrospective studies from India, Pakistan, Indonesia, Papua New Guinea and Sudan support the existence of severe P. vivax malaria. However, inconsistent methodologies, definitions of severity, and use of diagnostic tests to exclude concomitant infection do not allow for standardised assessments for severe P. vivax infection across studies. A review by Baird, highlighted that the risk of being classed as suffering from severe illness was only minimally higher in P. falciparum than in P. vivax, but was unable to combine the data as a meta-analysis. The primary reported symptoms for severe P. vivax included severe anaemia particularly in children, severe thrombocytopaenia, respiratory distress, neurological syndromes (coma or seizures), renal and hepatic failure.
Read more
Prospective studies have shown similar results. Tjitra et al showed that 23% (675 of 2,937) patients admitted with microscopically diagnosed P. vivax infections in Papua, Indonesia had severe disease and that the risk of severe malaria was significantly higher when admitted with P. vivax than with P. falciparum. In studies from Papua New Guinea, few differences between the clinical presentation of P. falciparum and P. vivax were found in children with severe malaria. This appears to be similar in populations from Sudan, Pakistan and India. In contrast, in Thailand, anecdotal observations note a low prevalence of severe P. vivax infections.
The WHO criteria to assess severe P. falciparum have been extrapolated to P. vivax. In the 2015 WHO malaria guidelines some criteria now account for P. vivax, such as removing a minimum parasitaemia when assessing for severe anaemia. Whilst these criteria may not be the most sensitive tool to define severe P. vivax infections, it is used for this purpose. It has been suggested that additional clinical information may be necessary to define truly severe P. vivax cases.
In order to describe the characteristics of the severity of P. vivax infections in north-western Thailand, we will perform a retrospective review of annual reports of the outpatient database, the inpatient database and eligible inpatient medical records from 2001 to 2016. The WHO malaria guidelines and additional clinical information will be used to assess the severity of infection and thus, a rate of severe P. vivax can be determined.
- Conditions
- Malaria, Vivax
- Keywords
- Severe malaria, plasmodium vivax
- Medical subject headings
- Malaria, Vivax, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of the number of severe cases determined to be caused by P. vivax to the number of outpatient cases treated for P. vivax
Measured: 1 year
Secondary outcomes (7)
Compare the age of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the sex of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the medical history of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the parasitaemia of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the duration of hospital stay of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the use of intravenous anti-malarial of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Measured: 1 year
Compare the blood transfusion of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
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 posted11 Oct 2017
- Study start27 Oct 2017
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
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 University of OxfordThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307369
- Sponsor's protocol ID
- SMRU1706
- Acronym
- SeverePV
- Status last verified
- Aug 2020
- First submitted
- 5 Oct 2017
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Assess the Rate of Plasmodium Vivax Infections Presenting With Severe Symptoms From 2001 to 2016 in North-western Thailand
- ClinicalTrials.gov ID
- NCT03307369
- Acronym / sponsor ID
- SeverePV / SMRU1706
- Conditions
- Malaria, Vivax
- Keywords
- Severe malaria, plasmodium vivax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 11 Oct 2017 (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.
Historically, Plasmodium vivax has been termed "benign" due to its non-life threatening clinical course and since the 1800's this view has been cultivated as demonstrated by the use of the term "benign tertian malaria" to describe the infection.However over the last 15 years, more severe P. vivax malaria is being reported, causing concern that severe P. vivax malaria is under diagnosed. The definition of severe P. vivax malaria borrows from P. falciparum and is primarily one of exclusion. Species PCR (polymerase chain reaction) is the only way to prove P. vivax mono-infection but is expensive and requires skilled staff and technology. In resource constrained settings, diagnostic testing is not available for detection of most non-malarial infections further affecting the ability to determine whether severe symptoms are due to P. vivax malarial infection or a concomitant one.
Retrospective studies from India, Pakistan, Indonesia, Papua New Guinea and Sudan support the existence of severe P. vivax malaria. However, inconsistent methodologies, definitions of severity, and use of diagnostic tests to exclude concomitant infection do not allow for standardised assessments for severe P. vivax infection across studies. A review by Baird, highlighted that the risk of being classed as suffering from severe illness was only minimally higher in P. falciparum than in P. vivax, but was unable to combine the data as a meta-analysis. The primary reported symptoms for severe P. vivax included severe anaemia particularly in children, severe thrombocytopaenia, respiratory distress, neurological syndromes (coma or seizures), renal and hepatic failure.
Prospective studies have shown similar results. Tjitra et al showed that 23% (675 of 2,937) patients admitted with microscopically diagnosed P. vivax infections in Papua, Indonesia had severe disease and that the risk of severe malaria was significantly higher when admitted with P. vivax than with P. falciparum. In studies from Papua New Guinea, few differences between the clinical presentation of P. falciparum and P. vivax were found in children with severe malaria. This appears to be similar in populations from Sudan, Pakistan and India. In contrast, in Thailand, anecdotal observations note a low prevalence of severe P. vivax infections.
The WHO criteria to assess severe P. falciparum have been extrapolated to P. vivax. In the 2015 WHO malaria guidelines some criteria now account for P. vivax, such as removing a minimum parasitaemia when assessing for severe anaemia. Whilst these criteria may not be the most sensitive tool to define severe P. vivax infections, it is used for this purpose. It has been suggested that additional clinical information may be necessary to define truly severe P. vivax cases.
In order to describe the characteristics of the severity of P. vivax infections in north-western Thailand, we will perform a retrospective review of annual reports of the outpatient database, the inpatient database and eligible inpatient medical records from 2001 to 2016. The WHO malaria guidelines and additional clinical information will be used to assess the severity of infection and thus, a rate of severe P. vivax can be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The retrospective data from approximately 600 P.vivax infected patients who have had routine clinical work performed in the outpatient and inpatient departments at SMRU during 2001-2016. The patient population consists of refugees and migrants living along the Thailand Myanmar border in north-western Thailand who seek health care at the SMRU hospitals.
Key inclusion criteria (1 listed)
- Patients voluntarily presented at SMRU clinic during 2001-2016 with a diagnosis of P. vivax mono-infection
Key exclusion criteria (1 listed)
- Patients voluntarily presented at SMRU clinic during 2001-2016 with fever and were seeking consultation for the treatment of malaria or other infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ratio of the number of severe cases determined to be caused by P. vivax to the number of outpatient cases treated for P. vivax
Time frame: 1 year
7 secondary outcomes
Compare the age of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the sex of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the medical history of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the parasitaemia of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the duration of hospital stay of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the use of intravenous anti-malarial of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
Compare the blood transfusion of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax
Time frame: 1 year
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 27 Aug 2020.
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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?
An observational study of Malaria, Vivax, run by University of Oxford at 1 site in Thailand.
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 1 inclusion and 1 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 27 Aug 2020. 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 Thailand. 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?
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 ratio of the number of severe cases determined to be caused by P. vivax to the number of outpatient cases treated for P. vivax (time frame: 1 year). 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 27 Aug 2020; AzTrials last refreshed its copy on 4 Nov 2026.