Cephalexin for Cystic Fibrosis

BC Children's Hospital, Vancouver, Canada
Cephalexin +1 morePhase 3RecruitingLed by Jonathan Rayment, MDCMResearch Sponsored by University of British Columbia

Study Summary

This trial will test whether the antibiotic cephalexin can improve lung function in children with cystic fibrosis who have grown a specific type of bacteria.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your breathing problems should not get worse for 28 days compared to how you were feeling before the study.
You have been diagnosed with cystic fibrosis based on certain symptoms or positive newborn screening results.


Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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).
Secondary outcome measures
Absolute change in FEV1 (mL) between day 0 and day 14
Absolute change in the CFQ-R(R) between day 0 and day 14.
MSSA airway culture positivity at day 14
+5 more

Side effects data

From 2013 Phase 2 & 3 trial • 2265 Patients • NCT00729937
Abdominal pain upper
Study treatment Arm
Abscess, Placebo
Abscess, TMP/SMX
Infected Wound, TMP/SMX
Infected Wound, Clindamycin
Cellulitis, Cephalexin and TMP/SMX
Cellulitis, Cephalexin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CephalexinExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
The placebo will be available in both capsule and suspension format. Doses will be administered 3 times a day for 2 weeks
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER
659 Previous Clinical Trials
6,924,260 Total Patients Enrolled
23 Trials studying Cystic Fibrosis
2,076 Patients Enrolled for Cystic Fibrosis
University of British ColumbiaLead Sponsor
1,367 Previous Clinical Trials
1,439,650 Total Patients Enrolled
15 Trials studying Cystic Fibrosis
2,456 Patients Enrolled for Cystic Fibrosis
Jonathan Rayment, MDCMPrincipal Investigator
University of British Columbia
1 Previous Clinical Trials
500 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
500 Patients Enrolled for Cystic Fibrosis

Media Library

Cephalexin (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT04553419 — Phase 3
Cystic Fibrosis Research Study Groups: Placebo, Cephalexin
Cystic Fibrosis Clinical Trial 2023: Cephalexin Highlights & Side Effects. Trial Name: NCT04553419 — Phase 3
Cephalexin (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04553419 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Cephalexin for medical use?

"There is already some efficacy data for Cephalexin from Phase 3 trials, as well as multiple rounds of safety data, so it receives a score of 3."

Answered by AI

How many people are allowed to join this trial?

"The information available on reveals that this trial is currently looking for individuals to participate. The study was first posted on 7/27/2020, and the most recent update was 1/12/2022. They are recruiting for 86 participants from 2 locations."

Answered by AI

Is there still room for more people in this particular experiment?

"Yes, this trial is still recruiting patients. The study was posted on July 27th 2020 and updated January 12th of this year. They need 86 individuals total from 2 different locations."

Answered by AI

Are there many peer-reviewed papers on Cephalexin's efficacy?

"There are currently 14 ongoing studies investigating Cephalexin. 3 of these trials have reached Phase 3 status. Most of the research being conducted on Cephalexin is based in Morgantown, West Virginia; however, there are 44 different locations where clinical trials for this medication are taking place."

Answered by AI

Could I be a candidate for this research?

"This study is for 86 children and adolescents with cystic fibrosis (CF), aged 3 to 17 years. The CF participants should: a) weigh more than 10 kg; b) have had at least one airway culture positive for methicillin-sensitive Staphylococcus aureus(MSSA) in the past 24 months or on 10 of the most recent cultures, whichever is greater; and c) not have worse lower respiratory tract symptoms than at baseline for 28 days prior to randomization."

Answered by AI

Does this research opportunity have an age limit?

"This study is available for children aged 3-17."

Answered by AI

What are some common indications for Cephalexin?

"While most often used to treat streptococcus pneumoniae, cephalexin can also be administered to patients suffering from otitis media (om), genitourinary tract infection, and communicable diseases."

Answered by AI
~31 spots leftby Jun 2025