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

NCT06426212 | Recruiting

• 1 other identifier: 3-TEICO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs

Outcome Measures

Primary Outcomes (1)

• Describe the clinical characteristics and outcome of the study population.

  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.

  2 months

Study Arms (2)

patients with deep infections (deep seated infections - DSIs)

Drug: Use of teicoplanin three times a week

patients with superficial infections (non deep seated infections - NDSIs).

Drug: Use of teicoplanin three times a week

Interventions

Use of teicoplanin three times a week DRUG

retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs).

patients with deep infections (deep seated infections - DSIs); patients with superficial infections (non deep seated infections - NDSIs).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera di Lecco: lead

Study Sites (1)

Stefania Piconi

Lecco, 23900, Italy

RECRUITING

Central Study Contacts

Stefania Piconi, MD

CONTACT

+390341489890; s.piconi@asst-lecco.it

Silvia Pontiggia, MS

CONTACT

+390341253678; s.pontiggia@asst-lecco.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infectious Diseases Unit

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 23, 2024
• Study Start: May 7, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)