Study in adult patients to asses the need for antibiotic treatment in staphylococcal infection of the catheter.

Phase 1

• Conditions: Catheter bacteremia caused by coagulase-negative staphylococci.; MedDRA version: 20.0Level: LLTClassification code 10054637Term: Staphylococcal bacteremiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-003612-39-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-09
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Men and women over 18 years of age
2. Bacteremia due to coagulase-negative staphylococcal related to the venous catheter defined as detection of growth of coagulase-negative staphylococci (excluding S lugdunensis) in patients with a venous catheter, with the presence of clinical symptoms of infection and in the absence of other apparent foci of bacteremia, with the exception of the catheter itself.
3. Patients without risk factors for complications defined as absence of: septic shock, neutropenia (<500 Ne/uL), coagulase-negative staphylococci of the S lugdunensis type, moderate-severe valvular heart disease, artificial endovascular devices other than the catheter and signs of septic thrombophlebitis
4. Patients who have had the catheter removed within 24h prior to inclusion
5. Patients who have signed informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

1. Pregnant and breast-feeding patients
2. Patients who have not had the catheter removed
3. Patients with compromise of immunity
4. Hemodynamically unstable patients
5. Patients with prosthetic materials other than the catheter
6. Patients unable to give their informed consent freely or with inadequate cognitive capacity
7. Any circumstance that, at the discretion of the physician, may involve a risk or clinical detriment to the participation of the patient in the study or that interferes with the assessments of the same.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified