A study of aerosol Amikacin and Fosfomycin delivered via a new nebulizer system in mechanically ventilated patients.
- Conditions
- Ventilator Associated Pneumonia (VAP)Ventilator Associated Tracheobronchitis (VAT)Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12612000273886
- Lead Sponsor
- Cardeas Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 9
Clinical diagnosis of VAP or VAT and expected to be on mechanical ventilation for at least 3 days
Gram positive or gram negative stain of the tracheal aspirate
Able to produce 1ml of tracheal aspirate for PK analyses
1.Severely compromised or suppressed immune system prior to hospital admission
2.Fraction of Inspired Oxygen (FIO2) > 0.8 at enrolment
3.Relative hypoxemia (O2 saturation of less than 93% on an FIO2 =0.8) at enrolment
4.PEEP > 15cm H2O at enrolment
5.Creatinine > 0.18 mmol/L
6.Positive pregnancy screening test or breast feeding (for female participants only)
7.Burns to greater than 40% of the body
8.Current treatment with systemic amikacin or fosfomycin within 48 hours of dosing
9.A history of previous allergy or sensitivity to amikacin or fosfomycin
10.Participation in a clinical study with administration of an investigational drug product within three months of Investigational Product administration.
11.Blood hemoglobin < 70 g/L at enrolment.
12.Any other condition which in the view of the Investigator is likely to interfere with the study or put the patient at risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma PK amikacin/fosfomycin concentrations following 2ml, 4ml, 6ml, 8ml, 10ml and 12ml dosing of nebulised amikacin/fosfomycin[blood samples at pre dose, 10mins, 1hr, 2hr, 4hr, 6hr and 24hr post dose];Tracheal aspirate amikacin/fosfomycin concentrations following 2ml, 4ml, 6ml, 8ml, 10ml and 12ml dosing of nebulised amikacin/fosfomycin[Tracheal aspirate samples at pre dose, 15mins, 1hr, 2hr, 4hr, 6hr and 24hr post dose]
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of nebulised amikacin/fosfomycin[ongoing through study until 24 hrs post dose 3.<br><br>The following will be ultilised- physical exam, vital signs (incl Heart rate, rsp rate, Blood pressure and temp) Heamatology, serum biochemistry, Urinalysis, Oximetry and peak and plateau airway pressures.<br><br>Adverse events and SAEs will also be monitored by the PI from screening visit until 24 hours post dose 3. As this is a phase 1 study, adverse events and SAEs are unknown but will be recorded if/as they occur.];To evaluate doses of amikacin/fosfomycin for future studies[Ongoing through study until 24 hrs post dose 3. Final evaluation will not occur until all data is collected and analysed for Clinical Study Report.]