Anti-bacterial

Cephalexin for Cystic Fibrosis

BC Children's Hospital, Vancouver, Canada

Cephalexin +1 morePhase 3RecruitingLed by Jonathan Rayment, MDCMResearch Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No increase in lower respiratory tract symptoms from baseline for 28 days

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:

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow upsup to 12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

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

Select...

Your breathing problems should not get worse for 28 days compared to how you were feeling before the study.

Select...

You have been diagnosed with cystic fibrosis based on certain symptoms or positive newborn screening results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ up to 12 months

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

21%

Nausea

16%

Headache

15%

Diarrhoea

14%

Abscess

10%

Vomiting

Dizziness

Abdominal pain upper

Constipation

Pyrexia

Rash

Cellulitis

100%

80%

60%

40%

20%

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cephalexin

FDA approved

0 / 2Eligibility criteria met

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 clinicaltrials.gov 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

Recent research and studies

clinicaltrials.govStudy

Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF

Jonathan Rayment 2020. "Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04553419.