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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
Pivotal Trial

Summary

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.

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Absolute change in the CFQ-R(R) between day 0 and day 14.
Relative change in LCI5 between day 0 and day 14.

Side effects data

From 2013 Phase 2 & 3 trial • 2265 Patients • NCT00729937
21%
Nausea
16%
Headache
15%
Diarrhoea
14%
Abscess
10%
Vomiting
7%
Dizziness
6%
Abdominal pain upper
4%
Constipation
3%
Pyrexia
3%
Rash
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abscess, Placebo
Abscess, TMP/SMX
Infected Wound, TMP/SMX
Infected Wound, Clindamycin
Cellulitis, Cephalexin and TMP/SMX
Cellulitis, Cephalexin

Awards & Highlights

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
2012
Completed Phase 4
~4070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cystic Fibrosis (CF) include antibiotics like Cephalexin, which target and kill specific bacteria such as MSSA, and inhaled antibiotics like tobramycin and aztreonam, which target Pseudomonas aeruginosa. These antibiotics disrupt bacterial cell walls or protein synthesis, leading to bacterial death. Additionally, inhaled hypertonic saline and DNase help to hydrate and break down mucus in the lungs, improving airway clearance. These treatments are essential for CF patients as they manage chronic lung infections, reduce inflammation, and improve lung function, thereby enhancing quality of life and survival.
Drugs, Drugs, Drugs: Current Treatment Paradigms in Cystic Fibrosis Airway Infections.Cystic fibrosis: a clinical view.Targeting the Root Cause of Cystic Fibrosis.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER
710 Previous Clinical Trials
6,958,084 Total Patients Enrolled
23 Trials studying Cystic Fibrosis
2,016 Patients Enrolled for Cystic Fibrosis
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,375 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
~10 spots leftby Jun 2025