EAT-UPTratamiento con antibióticos en pacientes con infección urinaria crónica

Treatment dose antibiotic in combination with methenamine hippurate

Prophylactic dose antibiotic or methenamine hippurate monotherapy

Change in urinary white blood cell (WBC) count from baseline to Week 12.

Safety and tolerability of the intervention as indicated by changes in Urea (mmol/L) from baseline to week 12

Changes in EuroQol EQ-5D 5-Level Health Related Quality of Life Questionnaire (EQ-5D-5L) scores at week 12, adjusted for baseline

Changes in ICIQ Lower Urinary Tract Symptoms quality of life (ICIQ-LUTSqol)

Changes in Whittington 39-point Lower Urinary Tract Symptoms (W-39 LUTS) scores at week 12, adjusted for baseline

Patient Global Impression of Improvement (PGI-I) scores at week 12.

Safety and tolerability of the intervention as indicated by changes in Alanine Transaminase (ALT) (IU/L) from baseline to week 12

Participant satisfaction with medication using Lübeck Medication Satisfaction (LMS) Questionnaire scores at week 12

Treatment adherence assessed by the MARS-5 questionnaire at weeks 4, 8 and 12.

Frequency of rescue therapy use for participants requiring further treatment escalation for an acute flare of symptoms at 12

Changes in urine culture species, cfu/ml count, sensitivities and resistance profiles at week 12, adjusted for baseline

Changes in Perineal swab analyses of E.coli identified, sensitivities and resistance profiles at week 12, adjusted for baseline

Safety and tolerability of the intervention as indicated by changes in pulse (bpm) from baseline to Week 12

Safety and tolerability of the intervention as indicated by changes in blood pressure (mmHg) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in temperature (°) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in respiratory rate (breaths per minute)from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in weight (kg) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Haemoglobin (g/dL) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Red Blood Cell Count (10^12/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Platelets (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in total White Blood Cell Count (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Neutrophils (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Lymphocytes (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Monocytes (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Eosinophils (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Basophils (10^9/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Albumin (g/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Total Bilirubin (µmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Alkaline Phosphatase (ALP) (IU/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Calcium (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Carbon dioxide (bicarbonate) (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Chloride (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Creatinine (µmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.72m²) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Glucose (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Phosphorus inorganic (phosphate) (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Potassium (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by changes in Sodium (mmol/L) from baseline to week 12

Safety and tolerability of the intervention as indicated by the occurrence / severity of treatment related Adverse Events assessed by CTCAE v5.0 from baseline to week 12