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This will be a prospective observational multicentre study in real-life conditions of patients with complicated urinary infection of community presentation caused by Escherichia coli using intravenous fosfomycin, quinolones or beta-lactams.
It's a multicenter and multinational study and it will include 200 patients in the fosfomycin cohort and 200 patients in the control cohort (quinolones or beta-lactams).
The objectives are:
For objective 1, a study of prospective mated cohorts (fosfomycin cohort versus quinolones or beta-lactams cohort) will be performed, and for objectives 2 and 3 a prospective cohort study (fosfomycin cohort) will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosfomycin cohort: | Cohort of patients with complicated urinary tract infection caused by Escherichia coli treated with intravenous fosfomycin |
| |
| Quinolones or beta-lactams cohort | Cohort of patients with complicated urinary tract infection caused by Escherichia coli treated with intravenous quinolones or beta-lactams. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Intravenous fosfomycin | Other | Patients will be visited on days 1 (Day of the urine and blood culture taking), 2, 5, 7, 14, on the test of cure and on day 30. Visit on day 1: First day of treatment. Basal data collection. Visit on day 2: Blood collection to fosfomycin levels calculation. Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects. Visit on day 30: Assess mortality |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the proportion of subjects getting clinical-microbiological cure on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort | The difference in the proportion of subjects getting clinical-microbiological cure (disappearance of all new symptoms or signs related to urinary infection and negative uroculture) on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort | 21 days |
| The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure). | The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure). | 21 days |
| The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI. | The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates. | To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates. | 30 days |
| The difference in the proportion of solicited EAs in subjects in fosfomycin cohort and quinolones or beta-lactams cohort. |
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Fosfomycin cohort:
Control cohort (objective 1):
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Patient with complicated urinary tract infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Belén Gutiérrez Gutiérrez | Contact | 955 00 80 00 | belengutiguti@hotmail.com | |
| Elisa Moreno Mellado | Contact | 955 00 80 00 | elisamoreno500@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Belén Gutiérrez Gutiérrez | Hospital Universitario Virgen Macarena | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | 14004 | Spain |
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|
| Drug: Intravenous quinolone or beta-lactam | Other | Patients will be visited on days 1 (Day of the urine and blood culture taking), 5, 7, 14, on the test of cure and on day 30. Visit on day 1: First day of treatment. Basal data collection. Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects. Visit on day 30: Assess mortality |
|
The difference in the proportion of solicited EAs in subjects in fosfomycin cohort and quinolones or beta-lactams cohort. |
| Day 5 through Day 21 |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
|
| ID | Term |
|---|---|
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| ID | Term |
|---|---|
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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