SW Government-Sponsored Clinical Trial: Management of Urinary Tract Infections by Community Pharmacists

Not Applicable

Active, not recruiting

• Conditions: rinary tract infections; Urinary tract infections; Renal and Urogenital - Other renal and urogenital disorders; Public Health - Health service research

• Registration Number: ACTRN12623000882628
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 18143

Inclusion Criteria

Pharmacies and pharmacists recruited must meet the eligibility criteria (defined below) to participate in the study, reflecting the criteria set by the Authority under Section 10 Poisons and Therapeutic Good Act 1966 Clauses 170 and 171 of the Poisons and Therapeutic Goods Regulation 2208.

Community pharmacies
A community pharmacy in NSW or ACT must have a service room, consulting room, or area consistent with the following:

An ‘approved pharmacy’ means a pharmacy or class of pharmacies, approved in writing by the Chief Health Officer, which has a service room, consulting room, or area consistent with the following:
o the room or area is not to be used as a dispensary, storeroom, staff room or retail area,
o fully enclosed and provides adequate privacy (a divider or curtain in a dispensary, storeroom, staff room or retail area is not acceptable),
o has adequate lighting,
o is maintained at a comfortable ambient temperature,
o has a hand sanitisation facility,
o has ready access to a hand washing facility, and
o has sufficient floor area, clear of equipment and furniture, to accommodate the person receiving the consultation and an accompanying person, and to allow the pharmacist adequate space to manoeuvre.”

Pharmacies must have access to MedAdvisor to complete clinical record keeping for the purposes of the clinical trial assessment.

Pharmacists
The eligibility criteria for an approved pharmacist to participate in the study, which includes that the pharmacist must be:

employed or engaged in an ‘approved pharmacy’ who has successfully completed the following training:
•Australasian College of Pharmacy Uncomplicated Cystitis Treatment – Pharmacist Training; or
•Pharmaceutical Society of Australia Managing uncomplicated cystitis; and
•A series of study training module(s) that have been approved by the Chief Health Officer for the purposes of the clinical trial.”

A pharmacist is eligible to participate if they hold general registration as a pharmacist with the Australian Health Practitioner Regulation Agency (AHPRA). Pharmacists with provisional registration (intern pharmacists) and pharmacists with conditions on their registration are not eligible to participate in the trial.

The pharmacy must have at least one eligible pharmacist who is willing to provide their voluntary consent to participate, for the pharmacy to be eligible, and that there is always a pharmacist available to deliver the service during all opening hours of the pharmacy.

Patients
Eligible patients will be females aged between 18 years and 65 years presenting to community pharmacies in NSW, and 5 pharmacies in the ACT, with symptoms associated with an uncomplicated urinary tract infection.

Exclusion Criteria

Individuals who are not female and/or aged <18 years or >65 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified