PHARMACOKINETICS OF COLISTIN IN MDR-GNB OR XDR- GNB PNEUMONIA OR TRACHEOBRONCHITIS PATIENTS WHO ARE MECHANICALLY VENTILATED: A RANDOMIZED CONTROLLED TRIA

Phase 1

• Conditions: ventilator associated pneumonia or ventilator associated tracheobronchitis or health-care associated pneumonia or hospital acquired pneumonia; MedDRA version: 21.1Level: PTClassification code 10044314Term: TracheobronchitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10035701Term: Pneumonia gram-negative bacterial NOSSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 22.0Level: LLTClassification code 10047263Term: Ventilation pneumonitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002269-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- inpatients at U.O. of Anesthesia and Reanimation B - AOUI Verona
- age> 18 years
- both sexes;
- both women of childbearing age who taking contraceptives and who do not use them
- patients affected by HAP / HCAP / VAP / VAT
- patients subjected to invasive ventilation
- isolation from deep respiratory secretions of A.baumannii and / or P. aeruginosa sensitive to no more than two classes of antibiotics, one of which is represented by polymyxins (XDR) and / or Enterobacteriaceae resistant to carbapenems and sensitive to polymyxins (MDR or XDR), according to the following quantitative parameters:
- BAL (broncho-alveolar lavage):> 104 CFU / mL in the course of HAP / HCAP / VAP
- BAS (broncoaspirate):> 106 CFU / mL in the course of HAP / HCAP / VAP / VAT;
> 105 CFU / mL in the course of VAT
or patient known to be colonized intestinally (rectal surveillance buffer) or pharyngeal (surveillance pharyngeal swab) from the above-mentioned bacterial agents and waiting for the outcome of the BAL / BAL culture tests
N.B: all the microbiological tests must not have been performed more than one week before enrollment
- written informed consent by the patient (if the patient is unable to provide it at the beginning of the study, it will be obtained as soon as possible). If the patient is unable to provide consent, a legal representative of the subject is required to sign it.

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Pregnancy and breastfeeding
- Intermittent dialysis or CRRT (continuous renal replacement therapy)
- Concomitant enlistment in other research protocols
- Known intolerance to colistimethate sodium and / or to any of the excipients
- Use of intravenous colistimetate sodium and / or aerosol 7 days prior to enrollment
- Personal history or family history of myasthenia

Study & Design

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