Patients with Hemato-oncologic disease or undergoing Hematopoietic stem cell transplantation MedDRA version: 6.1 Level: PT Classification code 10003997
Conditions
Interventions
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Vancomycin
CAS Number: 1404-93-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients with Hickmann-Broviac catheter 2 Presence of catheter related blood stream infections 3 controindications to CVC removal 4 Infomed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 withdrawal of informed consent 2 Diagnosis of metastatic infection not evident at start of experimental therapy 3 absence of clinical/microbiological response after seven days of treatment 4 Development of adverse events related with experimental therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate efficacy of lock therapy for catheter related infections;Secondary Objective: 1. Evaluate tolerability of antibiotic lock 2. Evaluate feasibility of out patient therapy;Primary end point(s): Evaluate efficacy of lock therapy for catheter related infections | — |
Countries
Italy
Outcome results
None listed