Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF

NCT04553419 | Unknown Phase 3 DMC

• 1 other identifier: H19-00836
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

  14 days from randomization

• Relative change in LCI5 between day 0 and day 14.

  14 days from randomization

• Absolute change in the CFQ-R(R) between day 0 and day 14.

  up to 12 months

Study Arms (2)

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.

Drug: Cephalexin

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

Drug: Placebo

Interventions

Cephalexin DRUG

Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin

Cephalexin

Placebo DRUG

Cellulose capsules or suspension

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
• A documented genotype with two disease-causing mutations in the CFTR gene
• 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.
• Growth of isolated MSSA on bacterial airway culture from this Study Visit, including cultures collected up to 21 days before this study visit.
• Acceptable MBW test at this Study Visit, per the assessment of the Site MBW Operator.
• Participant willing to be randomised.

You may not qualify if:

• Chronic infection with any of the following: Pseudomonas aeruginosa, Burkholderia cepacia complex, Stenotrophomonas maltophilia or Achromobacter spp, MRSA or any non-tuberculous mycobacteria, where chronic infection is defined as ≥50% positive airway cultures over the previous 12 months or the past 4 airway cultures, which ever is greater (latest culture cannot be positive for Pseudomonas auruginosa).
• Chronic daily antibiotic use (oral, inhaled or intravenous; including azithromycin or cycling month inhaled antibiotics).
• Systemic corticosteroid use for any indication within 28 days.
• Allergic bronchopulmonary aspergillosis (ABPA) requiring corticosteroid therapy within 12 months.
• Known allergy to cephalexin or other cephalosporins.
• Previous organ transplantation.
• Clinical findings that, in the opinion of the Site Investigator, would compromise the safety of the participant or the quality of the study data.
• Known pregnancy or planning to become pregnant during the study.
• Increase in respiratory (upper or lower) symptoms from baseline in the previous 28 days.
• Diagnosis of a pulmonary exacerbation by the treating physician at the Study Visit.
• Change of any respiratory medications within 28 days.
• New diagnosis of allergic bronchopulmonary aspergillosis (ABPA) since previous encounter.
• New use of chronic daily antibiotics since previous encounter.
• Clinical findings that, in the opinion of the Site Investigator, would compromise the safety of the participant or the quality of the study data.

Sponsors & Collaborators

• University of British Columbia: lead
• The Hospital for Sick Children: collaborator

Study Sites (2)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

The Hospital For Sick Children

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jonathan Rayment, MDCM

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fareeha Khan

CONTACT

604-875-2345; fareeha.khan@bcchr.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: July 27, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 14, 2022

Record last verified: 2022-01

Locations

CA (2)