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Anti-bacterial

Antibiotics for Cystic Fibrosis (ASAP-CF Trial)

Phase 3

Recruiting

Led By Jonathan Rayment, MDCM

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

ASAP-CF Trial 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.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests whether Cephalexin (an oral antibiotic) improves lung function in stable cystic fibrosis patients compared to a placebo. It's randomized and double-blinded, meaning neither the researchers nor participants know who gets the real medicine during the two-week trial.See study design

What are the potential side effects?

Cephalexin may cause allergic reactions, digestive issues like diarrhea or nausea, skin rashes, or rarely more serious effects like kidney problems or severe allergic reactions.

ASAP-CF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

ASAP-CF 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

2012

Completed Phase 4

~4070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

690 Previous Clinical Trials

6,945,392 Total Patients Enrolled

23 Trials studying Cystic Fibrosis

2,068 Patients Enrolled for Cystic Fibrosis

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,032 Total Patients Enrolled

15 Trials studying Cystic Fibrosis

2,456 Patients Enrolled for Cystic Fibrosis

Jonathan Rayment, MDCMPrincipal InvestigatorUniversity 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: Cephalexin, Placebo

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.

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