AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Thailand1 site
  • Shoklo Malaria Research Unit

    Mae Sot, Changwat Tak, 63110

Other trials in Thailand

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.

  1. 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)
  1. Compare the age of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax

    Measured: 1 year

  2. Compare the sex of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax

    Measured: 1 year

  3. Compare the medical history of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax

    Measured: 1 year

  4. Compare the parasitaemia of inpatient cases that meet or do not meet the 2015 WHO criteria for severe P. vivax

    Measured: 1 year

  5. 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

  6. 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

  7. 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.

  1. First posted11 Oct 2017
  2. Study start27 Oct 2017
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in