Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02959957
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2016-10-13
Brief Title:
Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections
Sponsor:
Håkan Hanberger
Organization:
Public Health Agency of Sweden
Study Overview
Official Title:
A Randomized Controlled Multicentre Trial of Collateral Damage on the Intestinal Microbiota Inferred by Temocillin Versus Cefotaxime in Patients Receiving Empirical Treatment for Febrile Urinary Tract Infections
Status:
COMPLETED
Status Verified Date:
2019-09
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:
None
Brief Summary:
This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime in empiric treatment of febrile UTI Half of participants will receive temocillin and the other half will receive cefotaxime
Detailed Description:
Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria Temocillin is approved and marketed in a few European countries since the 1980s but not in Sweden
The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication
The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy
The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection
The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication
The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy
The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-003898-15 | EUDRACT_NUMBER | None | None |