CClinicalTrials.gg
RecruitingNCT064262123-TEICOUpdated May 23, 2024

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

An observational study in Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs, sponsored by Azienda Ospedaliera di Lecco. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Azienda Ospedaliera di Lecco · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 40 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Azienda Ospedaliera di Lecco is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Hospitalized patients
  • Patients who have received less than 4 doses of teicoplanin for any cause.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugUse 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).

06

What researchers measure

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.

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06426212
Lead sponsor
Azienda Ospedaliera di Lecco
Responsible party
Stefania Piconi (Director of Infectious Diseases Unit, Azienda Ospedaliera di Lecco) — Principal investigator
First posted
May 23, 2024
Start date
May 7, 2024
Primary completion
May 31, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
May 23, 2024

Study contacts

Stefania Piconi, MD
Contact
s.piconi@asst-lecco.it
+390341489890
Silvia Pontiggia, MS
Contact
s.pontiggia@asst-lecco.it
+390341253678

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion