Clinical trial NCT06426212: Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs
Lead sponsor: Azienda Ospedaliera di Lecco
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data of patients with deep seated infections - DSIs or non deep seated infections - NDSIs treated from January 2021 to October 2023 in the Manzoni hospital in Lecco will be collected from the medical records in order to record the clinical outcomes understood as clinical resolution vs therapeutic failure, change of therapy or recurrence of infection.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Describe the clinical characteristics and outcome of the study population.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Stefania Piconi
Study officials:
References: