Assessing whether testing of rectal swabs is as accurate as bulk faeces testing in diagnosis of bacterial infections.

Not Applicable

• Conditions: infectious disease; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12624000095561
• Lead Sponsor: Sunshine Coast Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-02
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Persons aged 18 and older

Able to consent to and perform the additional rectal swab test.

Close contact or person exposed, suspected or confirmed case associated with an outbreak of an enteric organism. E.g. hepatitis A outbreak, foodbourne outbreak.

Chronic carrier of an enteric organism that requires testing.

Person involved in a clinical encounter where they are, or likely suffering from a disease caused by an enteric organism. (E.g. person presenting to the GP or Emergency Department with diarrhoea or jaundice)

Exclusion Criteria

Persons unlikely (as judged by the clinician) to be harbouring an enteric organism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test accuracy of rectal swabs compared to the gold standard of bulk faeces testing[Paired sample testing. The metrics of sensitivity, specificity, positive predictive value, negative predictive value and receiver operating curve characteristics will be evaluated. Single timepoint tested]

Secondary Outcome Measures

Name	Time	Method
Cycle threshold value differences between rectal swabs and bulk faeces testing[Paired sample testing Single timepoint (time of test)];Testing preference[Subjective questionnaire post test After testing, during a routine follow-up phone call]