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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cephalexin | Experimental | Oral cephalexin (available in capsule or suspension format) dosed at 150 mg/kg/day. Doses will be administered 3 times a day for 2 weeks. |
|
| Placebo | Placebo Comparator | The placebo will be available in both capsule and suspension format. Doses will be administered 3 times a day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalexin | Drug | Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | 14 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Time to next pulmonary exacerbation | up to 12 months | |
| Relative change in percent predicted FEV1 between day 0 and day 14 | 14 days from randomization | |
| Absolute change in FEV1 (mL) between day 0 and day 14 |
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Inclusion Criteria:
Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
Age 3 years and over, up to 17th birthday.
Weight ≥ 10.0kg
No increase in lower respiratory tract symptoms from baseline for 28 days.
At least one episode of MSSA growth on airway culture in the past 24 months OR the past 10 airway cultures, which ever is greater.
Successful MBW test occasion at the Screening Visit, per the assessment of the Site MBW Operator.
Informed consent by participant or parent/legal guardian with written assent where age-appropriate.
Randomization inclusion at each visit(applied after every Study Visit in the Phase 1)
Exclusion Criteria:
Randomisation exclusion(applied after every Study Visit in the Phase 1)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fareeha Khan | Contact | 604-875-2345 | 7606 | fareeha.khan@bcchr.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Rayment, MDCM | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002506 | Cephalexin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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double-blinded
| Placebo |
| Drug |
Cellulose capsules or suspension |
|
| 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. | 14 days from randomization |
| Absolute change in the CFQ-R(R) between day 0 and day 14. | Cystic fibrosis questionnaire - revised (respiratory domain) | up to 12 months |
| MSSA airway culture positivity at day 14 | 14 days from randomization |
| Time until next growth of MSSA on clinical microbiology samples | up to 12 months |
| Number of new CF respiratory pathogens (P. aeruginosa etc) from clinical respiratory samples | up to 12 months |
| The Hospital For Sick Children | Recruiting | Toronto | Ontario | Canada |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |