Antibiotics for Cystic Fibrosis
(ASAP-CF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if the antibiotic Cephalexin can help children with cystic fibrosis and a specific bacterial infection (MSSA) by improving their lung function. Cephalexin has been used in previous studies for antistaphylococcal prophylaxis in infants and young children with cystic fibrosis.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial requires no changes in respiratory medications within 28 days before enrollment and no chronic daily antibiotic use.
Is cephalexin safe for humans?
How does the drug Cephalexin differ from other treatments for cystic fibrosis?
Cephalexin is a type of antibiotic known as a cephalosporin, which is generally used to treat bacterial infections by stopping the growth of bacteria. While it is not specifically highlighted in the research for treating Pseudomonas infections in cystic fibrosis, it may be considered for its broad-spectrum antibacterial properties. However, other cephalosporins like ceftazidime and cefsulodin are more commonly used for cystic fibrosis due to their specific effectiveness against Pseudomonas aeruginosa, a common bacteria in these patients.678910
Who Is on the Research Team?
Jonathan Rayment, MDCM
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for children with cystic fibrosis who have had a Staphylococcus aureus infection in the past two years, are between 3 years and under 17, weigh at least 10 kg, and haven't changed their respiratory meds recently. They can't join if they have chronic infections with certain bacteria or use daily antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral Cephalexin or placebo for 2 weeks to assess lung function improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cephalexin
- Placebo
Cephalexin is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
The Hospital for Sick Children
Collaborator