E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of the study is to assess the prophylactic use of antibiotics on urinary tract infection after urodynamic studies in women with incontinence or prolapse |
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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 |
The present study, a prospective randomized trial addresses the following question: What is the efficacy of a double 3 g dose of oral fosfomycin (Monuril) administered 2 hours before and after urodynamic investigations (UDS) and compared to placebo in order to prevent de novo urinary tract infection?
By answering that question, it will be possible to know whether it is useful to administer prophylactic antibiotics when performing UDS and if 2x 3g of fosfomycin is effective against most of the bacteria that are encountered.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. women aged 18- 80 years 2. attending the urodynamic outpatient clinic of the Department of Obstetrics and Gynecology at CHR La Citadelle, Liège for urodynamic investigations 3. without symptoms of urogenital infection at the time of UDS attested by a positive result at stick test of urinary sample 4. intellectually and/or linguistically able to understand the study 5. not suffering from mental disabilities (except depression and anxiety) 6. resident within the surroundings of Liege. 7. willing to give their written consent
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E.4 | Principal exclusion criteria |
History of recurrent urinary tract infection Impaired renal function Intermittent self-catheterization Presence of persistent urinary infection * Breastfeeding Pregnancy Short term child-bearing potential** Allergy to antibiotics Antibiotics in the previous 7 days
* urinary infection - indicated by a positive stick test for nitrites and/or pyuria - which does not respond adequately to fosfomycin trometamol administration on the long term (1 month) **sexually active women who apply an unreliable method of birth control or who have an acute wish to become pregnant
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E.5 End points |
E.5.1 | Primary end point(s) |
1. the presence of significant bacteriuria defined by more than 10,000 bacteria per millilitre of clean catch urine on culture obtained on day 3 after the UDS. 2. Caracterisation of the bacteria strains about their resistance to the standard antibiotic screening in the CHR microbiology Laboratory
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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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last visit of the last subject undergoing the trial |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |