This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks. A sensitive technique called MBW (multiple breath washout) will be used to look at how well the participants lungs are functioning during the study and to see if the antibiotic improves function. The primary outcome of the study will be the relative change in the MBW measurement (LCI2.5) between day 0 and day 14 of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin
Cellulose capsules or suspension
BC Children's Hospital
Vancouver, British Columbia, Canada
RECRUITINGThe Hospital For Sick Children
Toronto, Ontario, Canada
RECRUITINGThe relative change in LCI2.5 between day 0 and day 14 (relative change = [LCI2.5 at day 14-LCI2.5 at day 0]/LCI2.5 at day 0).
Lung clearance index (LCI) as measured using the multiple breath nitrogen washout (MBW) technique with the Exhlayzer D (Eco Medics, Durnten SUI) device.
Time frame: 14 days from randomization
Time to next pulmonary exacerbation
Time frame: up to 12 months
Relative change in percent predicted FEV1 between day 0 and day 14
Time frame: 14 days from randomization
Absolute change in FEV1 (mL) between day 0 and day 14
Time frame: 14 days from randomization
Relative change in LCI5 between day 0 and day 14.
Lung clearance index (LCI) as measured using the multiple breath nitrogen washout (MBW) technique with the Exhlayzer D (Eco Medics, Durnten SUI) device.
Time frame: 14 days from randomization
Absolute change in the CFQ-R(R) between day 0 and day 14.
Cystic fibrosis questionnaire - revised (respiratory domain)
Time frame: up to 12 months
MSSA airway culture positivity at day 14
Time frame: 14 days from randomization
Time until next growth of MSSA on clinical microbiology samples
Time frame: up to 12 months
Number of new CF respiratory pathogens (P. aeruginosa etc) from clinical respiratory samples
Time frame: up to 12 months
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