None listed
Conditions
Brief summary
Malaria is a major cause of mortality and morbidity worldwide and Papua New Guinea (PNG) is one of the countries of the Pacific region with a higher burden of the disease. Like other countries in the tropical area, in PNG the current malaria diagnosis relies on the use of rapid diagnostic tests or in the use of clinical skills and the direct observation of Plasmodium parasite by microscope; while diagnosis of parasite carriers by qPCR is only used for research proposals due to its complexity and cost. The Commonwealth Scientific and Industrial Research Organisation (CSIRO) has identified breath biomarkers in patients with malaria that can be used as an indirect marker for malaria infection prediction using an innovative and harmless tool. We propose a study to validate this technique as a potential diagnostic tool on the field in Lihir islands. While evaluating diagnostic tools for malaria, it is important to investigate the diagnostic capacity of the new tool not only among clinical cases, which tend to have a high parasite burden, but also among infected albeit asymptomatic carriers, which contribute importantly to maintaining transmission, albeit often carrying much smaller parasite numbers in their blood. Thus, we aim to perform two cross sectional studies, with the idea of testing breath biomarkers as a malaria diagnostic tool, by 1) recruiting febrile cases actively seeking care at the health unit (THIS STUDY), and 2) recruiting healthy individuals at the community level, some of which will be carrying malaria infections. The diagnostic capacity of the breath biomarkers will be compared against the usual diagnostic methodologies in the field (optic microscopy and/or RDT) and the gold standard molecular methods (PCR). The validation of breath biomarkers for diagnosis of malaria may open a spectrum of possibilities related with fast and harmless diagnostic tools for the routine work in a rural setting like PNG where multiple Plasmodium species coexist with a variety of diagnostic challenges, and may provide an additional and non-invasive diagnostic tool in the efforts towards malaria elimination.
Interventions
Analysis of biomarkers indicating malaria infection (clincial infection) from patient breath samples. Patients sampled twice to check the change in biomarker levels from febrile controls (no malaria infection) or healthy non-infected controls.
Sampling process
After signing the informed consent, a small questionnaire with medical and demographic data will be collected for each participant. Blood samples for qPCR analysis and blood slide and breath sample will be collected.
We will use finger p
Analysis of biomarkers indicating malaria infection (clincial infection) from patient breath samples. Patients sampled twice to check the change in biomarker levels from febrile controls (no malaria infection) or healthy non-infected controls. Sampling process After signing the informed consent, a small questionnaire with medical and demographic data will be collected for each participant. Blood samples for qPCR analysis and blood slide and breath sample will be collected. We will use finger prick to collect the amount of blood needed for the study. It will be three drops of blood, two for the thick and thin film examination and one drop for the qPCR test (approximately 750 µl). Breath sample will be collected as follows: Participants will be asked to exhale into the one use mouthpiece of the breath sampler for as long as they can or until the operator deems the sample to be sufficient. The process is repeated until 1L of breath is collected. Breath sampler will be connected to Tenax® sorbent tubes stored at 4°C. Tenax® sorbent tubes will capture only volatile organic compounds (VOC) from the breath samples, the rest of the breath sample is returned to the atmosphere. Tenax® sorbent tubes will be shipped at 4°C to CSIRO (Canberra, Australia) at weekly intervals for analysis. All participants will be asked for VOC a second breath separated by 6-12 hours. Dr Amalia Berna will supervise the analysis process of the breath samples in the CSIRO laboratory in Canberra and she will be in charge of the site investigators training in the sample collection, store and shipment of breath samples. Dr Livingstone Tavul will supervise the analysis process of the qPCR in the IMR Vector Borne Disease Unit in Madang. Dr Moses Laman and Dr Quique Bassat will supervise the clinical aspects of the project as well as the site investigators and young researchers work. Dr Oriol Mitja` will ensure that the recruitment tasks are properly done in Lihir Medical Centre and he will be involved in the supervision of the team on site.
Sponsors
CSIRO
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
cross sectional study to compare the breath biomarkers with microscopy: Male or female greater than 5 years. Febrile sickness for at least 24hours. Attending Lihir Medical Centre (Outpatient department or Emergency Room) Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent
Exclusion criteria
Not willing to participate in the study. Not able to exhale through the breath sampler. Complicated malaria cases. Consciousness impairment. Unable to be located during the following week in case of need. Participants with Sulphur-containing drug intake for the last 30 days will be excluded due to the possible presence of drug-related volatile compounds in the exhaled breath.
Outcome results
None listed