ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001158358

Ethics application status

Approved

Date submitted

1/08/2017

Date registered

8/08/2017

Date last updated

8/08/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Breath based diagnosis of malaria infection

Scientific title

Validation of breath biomarkers for diagnosis of malaria on Lihir Island, Papua New Guinea.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malaria

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Comparator / control treatment

Will compare the specificity and sensitivity of the breath biomarkers with the standard diagnostic for malaria diagnosis (microscope - thick and thin films).
Will compare the specificity and sensitivity of the breath biomarkers with the gold standard diagnostic for malaria diagnosis qPCR.

Control group

Active

Outcomes

Primary outcome [1]

To compare the specificity and sensitivity of the breath biomarker 1-methylthiopropane, with the gold standard for malaria diagnosis (microscope). The performance of breath biomarkers will be determined by calculating its sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) against the reference test. Sensitivity and Specificity of 95% and a precision of 5% are the required for success. This will lead us to accept the results when the results for the sensitivity and specificity of the new test will be between 90 and 100%.

Timepoint [1]