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

NCT ID: NCT06426212

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-07

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with deep infections (deep seated infections - DSIs)

Use of teicoplanin three times a week

Intervention Type 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 superficial infections (non deep seated infections - NDSIs).

Use of teicoplanin three times a week

Intervention Type 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).

Interventions

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Use of teicoplanin three times a week

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).

Intervention Type DRUG

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Lecco

OTHER

Sponsor Role lead

Responsible Party

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Stefania Piconi

Director of Infectious Diseases Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stefania Piconi

Lecco, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefania Piconi, MD

Role: CONTACT

+390341489890

Silvia Pontiggia, MS

Role: CONTACT

+390341253678

Facility Contacts

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Stefania Piconi, MD

Role: primary

+390341489890

Silvia Pontiggia, MS

Role: backup

+390341253678

Other Identifiers

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3-TEICO

Identifier Type: -

Identifier Source: org_study_id

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