Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02650518
Eligibility Criteria:
Inclusion Criteria:
1. Inpatients ≥ 21 years old.
2. Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
3. Fever \>38°C.
4. A urine specimen sent to the hospital microbiological laboratory for culture.
5. An antibiotic order for presumed symptomatic catheter associated urinary tract infection.
Exclusion Criteria:
1. Persistent fever \>38°C for more than 24 hours, or any fever \>38.9°C.
2. Haemodynamic instability, defined as:
* Requirement for intravenous vasopressor agents
* Systolic blood pressure \<90 mmHg
* Acute hypotensive event with drop in systolic blood pressure of \>30 mmHg or diastolic blood pressure of \>20 mmHg
3. The following laboratory values within the previous 48 hours (if available):
* White blood cell count\>15 or \<4 x10\^9/L.
* Procalcitonin\>0.25ug/mL
* C Reactive Protein \>100mg/mL
* An increase in the serum creatinine of more than 50% from baseline
4. New requirement for oxygen supplement.
5. Current admission to a high dependency unit or ICU.
6. Radiological evidence of an upper urinary tract infection
7. Flank pain or tenderness, suggesting an upper urinary tract infection
8. Urologic surgical procedure within the previous 72 hours
9. Known structural genitourinary abnormalities including:
* Nephrostomy tubes
* Tumours of the urinary tract
* Ureteric stenting
* Ureteric strictures
* Urolithiasis
10. Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
11. Received antibiotics for more than 48 hours prior to randomization.
12. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
13. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
14. Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02650518
Study Brief:
Protocol Section:
NCT02650518