Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426212
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-08
Brief Title:
Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit
Sponsor:
Azienda Ospedaliera di Lecco
Organization:
Azienda Ospedaliera di Lecco
Study Overview
Official Title:
Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital Lecco Italy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
3-TEICO
Brief Summary:
Teicoplanin is an antibiotic belonging to the class of glycopeptides in use since 1986 Like its older classmate vancomycin it inhibits protein synthesis by interfering with the synthesis of peptidoglycan and is active on Gram-positive bacteria such as Staphilococcus spp including MRSA Streptococcus spp and Enterococcus spp both faecalis and faecium
Teicoplanin is characterized by poor gastrointestinal absorption which requires intramuscular or intravenous administration has a binding to plasma proteins greater than 90 and a high volume of distribution It reaches high levels in deep tissues bone abdomen lung kidney heart on the contrary it has poor penetration at the central nervous system level it is approved for the treatment of skin and soft tissue infections osteo-articular infections pneumonia endocarditis complicated urinary tract infections peritonitis and bacteremia associated with the aforementioned clinical conditions Furthermore teicoplanin has a markedly long half-life between 30 and 180h which allows it to be administered even every 48-72h Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function The possibility of carrying out therapeutic drug monitoring TDM allows maintaining plasma levels adequate for the treatment of deep infections eg 20 mgl for endocarditis and avoiding overdose
Thanks to the possibility of administering teicoplanin on a three-weekly schedule patient access to hospital is further reduced
The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections deep seated infections - DSIs and superficial infections non-deep seated infections - NDSIs
Teicoplanin is characterized by poor gastrointestinal absorption which requires intramuscular or intravenous administration has a binding to plasma proteins greater than 90 and a high volume of distribution It reaches high levels in deep tissues bone abdomen lung kidney heart on the contrary it has poor penetration at the central nervous system level it is approved for the treatment of skin and soft tissue infections osteo-articular infections pneumonia endocarditis complicated urinary tract infections peritonitis and bacteremia associated with the aforementioned clinical conditions Furthermore teicoplanin has a markedly long half-life between 30 and 180h which allows it to be administered even every 48-72h Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function The possibility of carrying out therapeutic drug monitoring TDM allows maintaining plasma levels adequate for the treatment of deep infections eg 20 mgl for endocarditis and avoiding overdose
Thanks to the possibility of administering teicoplanin on a three-weekly schedule patient access to hospital is further reduced
The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections deep seated infections - DSIs and superficial infections non-deep seated infections - NDSIs
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