Cystic FibrosisPhase 3ASAP-CFNCT04553419
Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF
A Phase 3 study testing Cephalexin in people with Cystic Fibrosis, run by University of British Columbia at 2 sites in Canada.
Trial summary
This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Cephalexin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Jul 2020to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
- A documented genotype with two disease-causing mutations in the CFTR gene
- Age 3 years and over, up to 17th birthday.
- Weight ≥ 10.0kg
- No increase in lower respiratory tract symptoms from baseline for 28 days.
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- At least one episode of MSSA growth on airway culture in the past 24 months OR the past 10 airway cultures, which ever is greater.
- Successful MBW test occasion at the Screening Visit, per the assessment of the Site MBW Operator.
- Informed consent by participant or parent/legal guardian with written assent where age-appropriate.
- Randomization inclusion at each visit(applied after every Study Visit in the Phase 1)
- Growth of isolated MSSA on bacterial airway culture from this Study Visit, including cultures collected up to 21 days before this study visit.
- Acceptable MBW test at this Study Visit, per the assessment of the Site MBW Operator.
- Participant willing to be randomised.
Who cannot join
- Change of any respiratory medications within 28 days of enrollment (i.e. recent increase in pancreatic enzyme dosing, or similar, is not an exclusion).
- Chronic infection with any of the following: Pseudomonas aeruginosa, Burkholderia cepacia complex, Stenotrophomonas maltophilia or Achromobacter spp, MRSA or any non-tuberculous mycobacteria, where chronic infection is defined as ≥50% positive airway cultures over the previous 12 months or the past 4 airway cultures, which ever is greater (latest culture cannot be positive for Pseudomonas auruginosa).
- Chronic daily antibiotic use (oral, inhaled or intravenous; including azithromycin or cycling month inhaled antibiotics).
- Systemic corticosteroid use for any indication within 28 days.
- Allergic bronchopulmonary aspergillosis (ABPA) requiring corticosteroid therapy within 12 months.
- Known allergy to cephalexin or other cephalosporins.
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- Previous organ transplantation.
- Clinical findings that, in the opinion of the Site Investigator, would compromise the safety of the participant or the quality of the study data.
- Known pregnancy or planning to become pregnant during the study.
- Randomisation exclusion(applied after every Study Visit in the Phase 1)
- Increase in respiratory (upper or lower) symptoms from baseline in the previous 28 days.
- Diagnosis of a pulmonary exacerbation by the treating physician at the Study Visit.
- Change of any respiratory medications within 28 days.
- New diagnosis of allergic bronchopulmonary aspergillosis (ABPA) since previous encounter.
- New use of chronic daily antibiotics since previous encounter.
- Clinical findings that, in the opinion of the Site Investigator, would compromise the safety of the participant or the quality of the study data.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
The Hospital For Sick Children
Toronto, Ontario
Felix Ratjen
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Fareeha Khan, 604-875-2345 ext. 7606, fareeha.khan@bcchr.ca
Alam Lakhani, 604-875-2345 ext. 7606, alam.lakhani@cw.bc.ca
About this study
Official title: Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research Protocol
This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks.
A sensitive technique called MBW (multiple breath washout) will be used to look at how well the participants lungs are functioning during the study and to see if the antibiotic improves function. The primary outcome of the study will be the relative change in the MBW measurement (LCI2.5) between day 0 and day 14 of study treatment.
- Conditions
- Cystic Fibrosis
- Being tested
- Cephalexin, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CephalexinDrug
Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin
PlaceboDrug
Cellulose capsules or suspension
| Study group | Role | What they receive |
|---|---|---|
| Cephalexin | Experimental | 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. Receives: Drug: Cephalexin |
| Placebo | Placebo comparator | The placebo will be available in both capsule and suspension format. Doses will be administered 3 times a day for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Lung clearance index (LCI) as measured using the multiple breath nitrogen washout (MBW) technique with the Exhlayzer D (Eco Medics, Durnten SUI) device.
Measured: 14 days from randomization
Secondary outcomes (8)
Time to next pulmonary exacerbation
Measured: up to 12 months
Relative change in percent predicted FEV1 between day 0 and day 14
Measured: 14 days from randomization
Absolute change in FEV1 (mL) between day 0 and day 14
Measured: 14 days from randomization
Relative change in LCI5 between day 0 and day 14.
Lung clearance index (LCI) as measured using the multiple breath nitrogen washout (MBW) technique with the Exhlayzer D (Eco Medics, Durnten SUI) device.
Measured: 14 days from randomization
Absolute change in the CFQ-R(R) between day 0 and day 14.
Cystic fibrosis questionnaire - revised (respiratory domain)
Measured: up to 12 months
MSSA airway culture positivity at day 14
Measured: 14 days from randomization
Time until next growth of MSSA on clinical microbiology samples
Measured: up to 12 months
Number of new CF respiratory pathogens (P. aeruginosa etc) from clinical respiratory samples
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start27 Jul 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Jonathan Rayment, University of British Columbia
- Investigators
- Jonathan Rayment, MDCM, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553419
- Sponsor's protocol ID
- H19-00836
- Acronym
- ASAP-CF
- Status last verified
- Jan 2022
- First submitted
- 11 Sep 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research Protocol
- ClinicalTrials.gov ID
- NCT04553419
- Acronym / sponsor ID
- ASAP-CF / H19-00836
- Conditions
- Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks.
A sensitive technique called MBW (multiple breath washout) will be used to look at how well the participants lungs are functioning during the study and to see if the antibiotic improves function. The primary outcome of the study will be the relative change in the MBW measurement (LCI2.5) between day 0 and day 14 of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cephalexin | Experimental | Drug: CephalexinOral cephalexin (available in capsule or suspension format) dosed at 150 mg/kg/day. Doses will be administered 3 times a day for 2 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will be available in both capsule and suspension format. Doses will be administered 3 times a day for 2 weeks |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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:
- Age 3 years and over, up to 17th birthday.
- Weight ≥ 10.0kg
- No increase in lower respiratory tract symptoms from baseline for 28 days.
- At least one episode of MSSA growth on airway culture in the past 24 months OR the past 10 airway cultures, which ever is greater.
Key exclusion criteria (16 listed)
- Change of any respiratory medications within 28 days of enrollment (i.e. recent increase in pancreatic enzyme dosing, or similar, is not an exclusion).
- Chronic infection with any of the following: Pseudomonas aeruginosa, Burkholderia cepacia complex, Stenotrophomonas maltophilia or Achromobacter spp, MRSA or any non-tuberculous mycobacteria, where chronic infection is defined as ≥50% positive airway cultures over the previous 12 months or the past 4 airway cultures, which ever is greater (latest culture cannot be positive for Pseudomonas auruginosa).
- Chronic daily antibiotic use (oral, inhaled or intravenous; including azithromycin or cycling month inhaled antibiotics).
- Systemic corticosteroid use for any indication within 28 days.
- Allergic bronchopulmonary aspergillosis (ABPA) requiring corticosteroid therapy within 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CephalexinCephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin | Drug | Cephalexin |
| PlaceboCellulose capsules or suspension | Drug | Placebo |
Primary outcome
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).
Time frame: 14 days from randomization
Lung clearance index (LCI) as measured using the multiple breath nitrogen washout (MBW) technique with the Exhlayzer D (Eco Medics, Durnten SUI) device.
8 secondary outcomes
Time to next pulmonary exacerbation
Time frame: up to 12 months
Relative change in percent predicted FEV1 between day 0 and day 14
Time frame: 14 days from randomization
Absolute change in FEV1 (mL) between day 0 and day 14
Time frame: 14 days from randomization
Relative change in LCI5 between day 0 and day 14.
Time frame: 14 days from randomization
Absolute change in the CFQ-R(R) between day 0 and day 14.
Time frame: up to 12 months
MSSA airway culture positivity at day 14
Time frame: 14 days from randomization
Time until next growth of MSSA on clinical microbiology samples
Time frame: up to 12 months
Number of new CF respiratory pathogens (P. aeruginosa etc) from clinical respiratory samples
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Rayment, MDCM principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cephalexin in people with Cystic Fibrosis, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fareeha Khan (604-875-2345 ext. 7606, fareeha.khan@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 14 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.