Impact of duration of antibiotic treatment on the effectiveness, safety and selection of antibiotic resistance in adult women with urinary tract infections (UTI): a randomised controlled trial.

Phase 4

• Conditions: rinary tract infections (UTI), cystitis, pyelonephritis; Urological and Genital Diseases

• Registration Number: ISRCTN18390724
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-31
• Last Update Posted: 25 March 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2248

Inclusion Criteria

1. Female, aged 18 years or above
2. Participant is willing and able to give informed consent for participation in the trial.
3. Urine sample for culture has been/can be obtained prior to starting antibiotics
4. For pyelonephritis sub trial (primary and secondary care):
4.1. Presenting with acute pyelonephritis symptoms for which the responsible clinician considers antibiotic treatment is either indicated or for whom an antibiotic has already been started within the previous 48 hours.
4.2. Temperature of >38.0oC measured at presentation AND loin/flank pain or costovertebral angle tenderness AND =1 symptom of acute UTI (frequency, dysuria, urgency, nocturia, change in urine smell or appearance (e.g. cloudy or bloody urine), suprapubic pain).
4.3. If recruited in secondary care, willing to allow their General Practitioner, to be notified of participation in the trial
5. For the cystitis sub trial (primary care only):
5.1. Presenting with acute cystitis symptoms for which the responsible clinician consider antibiotic treatment is indicated
5.2. =two of the following symptoms of acute UTI (frequency, dysuria, urgency, nocturia, change in urine smell or appearance (e.g. cloudy or bloody urine), suprapubic pain).
6. English speaking

Exclusion Criteria

1. Antibiotics for the prevention or treatment of UTI within the previous month (n.b. Pyelonephritis patients that have started antibiotics within 48 hours are included).
2. Previous participation in the DURATION UTI Trial
3. Indwelling catheter
4. Inclusion in the trial is inappropriate in the judgement of the responsible clinician
5. Known anatomical abnormality of the urinary tract
6. Neurogenic bladder
7. Known pregnancy (pregnancy test not required for participation)
8. Unable to comply with study procedures
9. All antibiotic agents available to the participant in the trial are precluded in the view of the responsible clinician for example by:
9.1. patient factors (such as allergy, degree of renal impairment)
9.2. antibiotic susceptibility results (e.g. known carrier of antibiotic resistant organisms or resistance profile of the current infection if known at randomisation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified