Nosocomial Pneumonia MedDRA version: 8.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia
Conditions
Interventions
Product Name: Amikacin solution for inhalation 125mg/mL
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Amikacin sulphate
CAS Number: 39831-55-5
Concentration unit: mg milligram(s)
Concen
Sponsors
Nektar Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females, 18 years of age or older. For females of child-bearing potential, one of the following medically acceptable contraceptive methods must be used: a) Double-barrier methods of contraception (e.g. condoms plus spermicidal foam) b) Intrauterine contraceptive device c) Approved pharmaceutical contraceptive product (e.g. birth control pills or patches, longterm injectable or implantable hormonal contraceptive) 2. Intubated and mechanically-ventilated (patients who have had a tracheostomy may be considered as possible study participants) 3. Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph and presence of gram-negative organisms by gram stain of respiratory secretions (tracheal aspirate, BAL, mini-BAL, PBS) plus at least 2 of the following: a) Fever, defined as an oral temperature of > 38.0°C (100.4°F) or a rectal/core temperature > 39.0°C (102.2°F), or hypothermia, defined as a rectal/core body temperature of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Primary lung cancer or another malignancy metastatic to the lungs 2. Known or suspected active tuberculosis, cystic fibrosis, AIDS, or Pneumocystis carinii pneumonia 3. Receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications (including chronic treatment with >10 mg/day of systemic prednisone or equivalent) 4. BMI = 30 5. Burns greater than 40% of total body surface area 6. Any known chronic liver disease 7. Known local or systemic hypersensitivity to amikacin or aminoglycosides 8. Diagnosis of end stage renal failure or currently on dialysis 9. Severe hypoxemia as defined by Screening PaO2/FiO2 2 mg/dL 11. Screening serum albumin level 32 mcg/mL. 17. Community-acquired pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the pharmacokinetic (PK) profile of aerosolized amikacin administered via the PDDS Clinical in patients with nosocomial pneumonia caused by gram-negative organisms - To evaluate the safety and tolerability of aerosolized amikacin administered via PDDS Clinical in patients with nosocomial pneumonia caused by gram-negative organisms;Secondary Objective: ;Primary end point(s): Pharmacokinetic and Safety | — |
Countries
France
Outcome results
None listed