comparison between intravenous aminoglycosides versus nebulize aminoglycosides in cystic fibrosis patients
Phase 3
Recruiting
- Conditions
- cystic fibrosis.Cystic fibrosis
- Registration Number
- IRCT20120415009475N10
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
cystic fibrosis flare up
Exclusion Criteria
chronic kidney disease
hepatic failure
metabolic disorder
myopathy
hearing loss
neuromuscular disease
electrolyte disturbances
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Forced expiratory volume in the first second (FEV1). Timepoint: in baseline and 14 days after beginning of treatment. Method of measurement: Spirometer.
- Secondary Outcome Measures
Name Time Method Amikacin blood concentration. Timepoint: Before the 4th dose. Method of measurement: Amikacin ELISA Kit.;Hearing loss. Timepoint: In baseline and 14 days after beginning of treatment. Method of measurement: Auditory Brainstem Response (ABR) testing.;Serum cratinine. Timepoint: Every 48 hours. Method of measurement: Jaffe's Kinetic Method.;Hospital stay. Timepoint: Day. Method of measurement: Counting.