Efficacy of Intravenous Fosfomycin in the Treatment of Complicated Urinary in Real-life Conditions. (NCT04076436) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Intravenous Fosfomycin in the Treatment of Complicated Urinary in Real-life Conditions.
Spain400 participantsStarted 2019-10-21
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Fosfomycin cohort:
* Inclusion criteria: Patients over 18 years of age. Patients who have started treatment with intravenous fosfomycin, estimated that they will require at least 2 days of treatment with fosfomycin, initiated as either as empirical treatment (within 24 hours after the emergency visit or onset of symptoms) or targeted treatment (within 24 hours of the availability of the antibiogram).
* Exclusion criteria: Patients under 18 years of age. Patients in palliative treatment.
Control cohort (objective 1):
* Inclusion criteria:Patients over 18 years of age. Patients who have started treatment with intravenous quinolones or beta-lactams, estimated that they will require at least 2 days of treatment with the drug, initiated as either as empirical treatment (within 24 hours after the emergency visit or onset of symptoms) or targeted treatment (within 24 hours of the availability of the antibiogram). Each patient from the fosfomycin cohort will be matched with a patient from this control cohort according to their.
* Exclusion criteria: Patients under 18 years of age.Patients in palliative treatment; Informed consent not signed by the patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 21 days
2
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).
Timeframe: 21 days
3
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.
Timeframe: 30 days
Trial details
NCT IDNCT04076436
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla