Rescue therapy of tunnel/pocket infections of Hickman-Broviac/Port indwelling central venous catheters with antibiotic continuous infusion - ND
- Conditions
- Patients with Hemato-oncologic disease or undergoing Hematopoietic stem cell transplantationMedDRA version: 6.1Level: PTClassification code 10007882
- Registration Number
- EUCTR2006-002146-10-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1 Patients with Hickmann-Broviac or Port catheter 2 Presence of catheter related tunnel/pocket 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate efficacy of rescue treatment;Secondary Objective: 1. Evaluate tolerability of antibiotic lock 2. Evaluate feasibility of out patient therapy;Primary end point(s): Evaluate efficacy of rescue treatment
- Secondary Outcome Measures
Name Time Method