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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
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 • NCT0072993721%
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The participant should not have made changes to their respiratory medications within the last 28 days, have certain chronic infections, be using certain antibiotics or steroids, or have certain medical conditions. They should also not be pregnant or have certain respiratory symptoms or diagnoses.You have been diagnosed with cystic fibrosis (CF) through specific tests or screenings, and you meet certain age, weight, and symptom criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Cephalexin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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