Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04959331
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2021-07-05
Brief Title:
Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Clinical Effectiveness and Bacteriological Eradication of Three Different Short-course Antibiotic Regimens and Single-dose Fosfomycin for Uncomplicated Lower Urinary Tract Infections in Adult Women
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCOUT
Brief Summary:
Randomized clinical trial in which women aged 18 or older and with symptoms of uncomplicated lower urinary tract infection and a positive urine dipstick analysis will be randomized to one of the following four groups 2-day 3 g fosfomycin od 3-day pivmecillinam 400 mg tid 5-day nitrofurantoin 100 mg tid or a single dose of 3 g of fosfomycin Sample 1000 patients Two co-primary endpoints are considered clinical effectiveness at day 7 and bacteriological eradication at day 14 Follow-up visits are scheduled at days 7 phone call 14 and 28 for assessing evolution Urine samples will be collected in the three on-site visits and urine cultures performed
Detailed Description:
Uncomplicated lower urinary tract infections LUTI represent a common problem in primary care Resistance of uropathogens to common antibiotics has significantly increased in the last years Current local guidelines recommend the use of a single 3 g dose of fosfomycin for these infections but most general practitioners prefer short-course therapies to single-dose therapy No study has compared head-to-head short course antimicrobial agents for uncomplicated LUTIs Therefore the aim of this randomized clinical trial is to compare three different short-course antibiotic therapies with single-dose fosfomycin for uncomplicated LUTIs in adult women This will be a pragmatic multicenter parallel group open randomized trial Women aged 18 or older and with symptoms of uncomplicated LUTI and a positive urine dipstick analysis will be randomized to one of the following four groups 2-day 3 g fosfomycin od 3-day pivmecillinam 400 mg tid 5-day nitrofurantoin 100 mg tid or a single dose of 3 g of fosfomycin Sample 1000 patients Two co-primary endpoints are considered clinical effectiveness defined as resolution of symptoms answered by the patients at day 7 and bacteriological eradication proportion of patients bacteriologically cured at day 14 Patients will be given a symptom diary for seven days Follow-up visits are scheduled at days 7 phone call 14 and 28 for assessing evolution Urine samples will be collected in the three on-site visits and urine cultures performed If positive antibiograms for the 3 antibiotics studied will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None