Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-09
Brief Title:
Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone NF Gamaleya NRCEM in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology Health Ministry of the Russian Federation
Organization:
Gamaleya Research Institute of Epidemiology and Microbiology Health Ministry of the Russian Federation
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of the Drug Fluorothiazinone Gamaleya Research Institute of Epidemiology and Microbiology Health Ministry of the Russian Federation in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on Mechanical Ventilation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 is designed to evaluate the clinical and antibacterial efficacy safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation
The main objectives of this study are
Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation
Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation
Evaluation of the pharmacokinetics in whole blood of the drug Fluorothiazinone with a single daily dose of 2400 mgday
Researchers will compare results for the treatment and the placebo arms
The main objectives of this study are
Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation
Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation
Evaluation of the pharmacokinetics in whole blood of the drug Fluorothiazinone with a single daily dose of 2400 mgday
Researchers will compare results for the treatment and the placebo arms
Detailed Description:
None
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