Malaria, Vivax Clinical Trial
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.
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.
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