## Protocol Section
### Identification Module
**NCT ID:** NCT06426212

**Acronym:** 3-TEICO

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 3-TEICO
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliera di Lecco
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda Ospedaliera di Lecco

#### Responsible Party

**Investigator Affiliation:** Azienda Ospedaliera di Lecco

**Investigator Full Name:** Stefania Piconi

**Investigator Title:** Director of Infectious Diseases Unit

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

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

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Use of teicoplanin three times a week

**Label:** patients with deep infections (deep seated infections - DSIs)

#### Arm Group 2

**Intervention Names:**

- Drug: Use of teicoplanin three times a week

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

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patients with deep infections (deep seated infections - DSIs)

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

**Description:** 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).

**Name:** Use of teicoplanin three times a week

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Describe the clinical characteristics and outcome of the study population.

**Time Frame:** 2 months

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** s.piconi@asst-lecco.it

**Name:** Stefania Piconi, MD

**Phone:** +390341489890

**Role:** CONTACT

**Contact 2:**

**Email:** s.pontiggia@asst-lecco.it

**Name:** Silvia Pontiggia, MS

**Phone:** +390341253678

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lecco

**Contacts:**

***Contact 1:***

- **Email:** s.piconi@asst-lecco.it

- **Name:** Stefania Piconi, MD

- **Phone:** +390341489890

- **Role:** CONTACT

***Contact 2:***

- **Email:** s.pontiggia@asst-lecco.it

- **Name:** Silvia Pontiggia, MS

- **Phone:** +390341253678

- **Role:** CONTACT

**Country:** Italy

**Facility:** Stefania Piconi

**Status:** RECRUITING

**Zip:** 23900

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infectious Disease

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infectious Disease

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19621

- Name: Teicoplanin

- Relevance: HIGH

- As Found: Soda

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017334

- Term: Teicoplanin

### Misc Info Module

- Version Holder: 2024-05-31
