Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit

Recruiting

• Conditions: Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs
• Interventions: Drug: Use of teicoplanin three times a week

• Registration Number: NCT06426212
• Lead Sponsor: Azienda Ospedaliera di Lecco

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 (e.g. \>20 mg/l 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

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-07
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age >18 years;
• Patients with documented Gram-positive infection sensitive to teicoplanin;
• Patients who have received at least 4 doses of teicoplanin on a three-weekly schedule, as monotherapy or associated with other antibiotics

Exclusion Criteria

• Hospitalized patients
• Patients who have received less than 4 doses of teicoplanin for any cause.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with superficial infections (non deep seated infections - NDSIs).	Use of teicoplanin three times a week	-
patients with deep infections (deep seated infections - DSIs)	Use of teicoplanin three times a week	-

Primary Outcome Measures

Name	Time	Method
Describe the clinical characteristics and outcome of the study population.	2 months	Describe the clinical characteristics of patients and outcome (recovery vs therapeutic failure intended as death, need for modification of antibiotic therapy or recurrence of infection) of the study population.

Trial Locations

Locations (1)

Stefania Piconi; 🇮🇹 Lecco, Italy