Catheter bacteremia caused by coagulase-negative staphylococci. MedDRA version: 20.0 Level: LLT Classification code 10054637 Term: Staphylococcal bacteremia System Organ Class: 100000004862
Conditions
Interventions
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: DALBAVANCIN
CAS Number: 171500-79-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare in terms of efficacy and safety the strategy of not administering antibiotic treatment with that of treatment with antibiotic, in episodes of catheter bacteremia due to coagulase-negative staphylococci in patients without risk factors for complications.;Secondary Objective: To compare the two study arms in terms of: - Adverse events - Time to microbiological cure - Time to disappearance of fever - Costs derived from the treatment;Primary end point(s): A variable composed by the presence of persistent bacteremia, complicated bacteremia or the presence of any complication related to bacteremia or derived from the administration of antibiotics during the trial.;Timepoint(s) of evaluation of this end point: Days 1, 2, 3, 4, 5, 6, 7 and every additional day until the resolution of bacteremia or end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Presence of persistent bacteremia, complicated bacteremia, presence of any complication related to bacteremia or derived from the administration of antibiotics during the trial, time to microbiological cure, time to the disappearance of fever and costs derived from treatment.;Timepoint(s) of evaluation of this end point: Days 1, 2, 3, 4, 5, 6, 7 and every additional day until the resolution of bacteremia or end of treatment. | — |
Countries
Spain
Contacts
Public ContactOficina de Recerca
Hospital Universitari Parc Taulí
Outcome results
None listed