Status:
UNKNOWN
Antibiotics Continuous Infusion at Home
Lead Sponsor:
Ospedale San Carlo Borromeo
Collaborating Sponsors:
Associazione Oncologica Milanese AmoLaVita ONLUS
Conditions:
Severe Bacterial Infections
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
BACKGROUND: The spread of multidrug-resistant bacteria represents a well-known problem, which must be face up by optimizing antibiotic therapy both in terms of choosing the most appropriate drug and o...
Detailed Description
STATISTICAL ANALYSIS: This is an interventional monocentric study. The primary endpoint of the study is a reduction in hospitalization days. The study population is divided into 4 treatment arms: assu...
Eligibility Criteria
Inclusion
- Patients aged 18 to 90 years.
- Ability to understand and sign informed consent.
- Treatment infection responsive to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
- Absence of allergies to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
- Evidence of clinical response to treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin and at least 3 days of apyrexia with current infusion antibiotic therapy.
- Good tolerance to ongoing antibiotic treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
Exclusion
- Inability for any reason (e.g. absence of caregiver) to manage the elastomeric pump and access the hospital on a daily basis.
- Lack of adequate venous access.
- Inability to hydrate themselves properly orally.
- Infection involving the central nervous system.
- Creatinine\> 2 mg / dL.
- Neutrophil granulocytes ≤ 1000 / µL.
- Platelets ≤ 20000 / µL.
- "aspartate amino transferase" and "alanine amino transferase" \> 100 U / L.
- Bilirubin\> 3 mg / dL.
- Presence of any comorbidities that, in the opinion of the physician, could compromise the safe execution of antibiotic home continuous infusion.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04816968
Start Date
September 1 2021
End Date
December 1 2023
Last Update
March 25 2021
Active Locations (1)
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1
ASST Santi Paolo Carlo - San Carlo Borromeo Hospital - SSd Onco-Hematology
Milan, Italy, 20153