E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adults presenting at primary care or emergency department with febrile urinary tract infection. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether a 7-day duration of antibiotic treatment is non inferior to 14-day standard duration of treatment in adult patients presenting at primary care or emergency department with febrile urinary tract infection |
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E.2.2 | Secondary objectives of the trial |
The assessment of clinical parameters and biomarkers in blood and urine of adult patients presenting at primary care or emergency department with febrile urinary tract infection, in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality an d to determine the prevalence of pelvic floor dysfunction and the occurrence of Clostridium Difficile associated diarrhea |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Competent patient aged 18 years or above 2. One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain) 3. Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours 4. Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy
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E.4 | Principal exclusion criteria |
1. Known allergy to fluoroquinolones 2. Female patients who are pregnant or lactating 3. Patients with known polycystic kidney disease 4. Patients on permanent renal replacememt therapy (hemodialysis or peritoneal dialysis) 5. Patients with history of kidney transplantation 6. Residence outside country of enrolment 7. Inability to speak or read Dutch
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is clinical cure rate (i.e., resolution of symptoms and fever) among evaluable patients through the 10- to 18-day posttherapy visit. Evaluable patients for Intention-to-Treat analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received at least one dose of study drugs and (3) follow-up visit. Evaluable patients for Per-Protocol analysis are those who met the following criteria: (1) enrollment criteria of febrile urinary tract infection, (2) received the study drug for a minimum of 24 hours (in case of treatment failure) or received at least 80% of the study drug (in case of clinical cure) and (3) follow-up visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
clinical and biomarker predictors |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last included patient according to the calcualted sample size. Determined by the data safety monitoring board based on the interim analysis after 50% of included patient who met follow up visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |