Cystic FibrosisNCT05584982
Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
A study testing AtbFinder in people with Cystic Fibrosis and Lung Infection Bacterial, run by TGV-Dx.
Trial summary
This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Lung Infection Bacterial
- What is being tested?
- AtbFinder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 12 Oct 2022
- Phase
- Interventional
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of cystic fibrosis based on sweat chloride levels = or > 60, or genetic testing showing 2 pathogenic mutations.
- Ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment.
- Prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year.
Who cannot join
- Inability to meet any of the above inclusion criteria.
- Systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics.
- Primary or secondary (drug- or condition-induced) immune compromise.
- Creatinine > 2 x upper limit of normal for age.
- Previous participation in this study in the prior 28 days.
About this study
Official title: Open-label, Single-arm, Investigator-Initiated Clinical Study to Investigate the Performance of the AtbFinder® Diagnostic Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.
Read the detailed description
This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the AtbFinder® for the treatment of lung infections in persons with cystic fibrosis.
- Conditions
- Cystic Fibrosis, Lung Infection Bacterial
- Being tested
- AtbFinder
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtbFinderDevice
In the present study, we provided a prospective evaluation of the effectiveness of antibiotics selected with AtbFinder compared to a retrospective analysis of antibiotic efficacy selected with conventional culture-based antibiotic susceptibility tets in patients with cystic fibrosis
| Study group | Role | What they receive |
|---|---|---|
| AtbFinder-1 | Experimental | persons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen Receives: Device: AtbFinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to an exacerbation (in months)
Measured: Time Frame: up to 24 months
Secondary outcomes (7)
Evaluate changes in forced expiratory volume from baseline to end of study
Measured: Time Frame: up to 24 months
Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
Measured: Time Frame: up to 24 months
Changes in bacterial load of isolated organisms (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
Measured: Time Frame: up to 24 months
Changes in blood white blood cell count (10*9 mg/L)
Measured: Time Frame: up to 24 months
Changes in blood C-reactive protein (in mg/L)
Measured: Time Frame: up to 24 months
Changes in weight (in kilograms)
Measured: Time Frame: up to 24 months
Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).
Measured: Time Frame: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study startJan 2016
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- TGV-Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584982
- Sponsor's protocol ID
- Atbfinder-CF1
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Investigator-Initiated Clinical Study to Investigate the Performance of the AtbFinder® Diagnostic Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05584982
- Acronym / sponsor ID
- Atbfinder-CF1
- Conditions
- Cystic Fibrosis, Lung Infection Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- TGV-DxIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 18 Oct 2022 (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 prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.
Detailed description
This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the AtbFinder® for the treatment of lung infections in persons with cystic fibrosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtbFinder-1 | Experimental | Device: AtbFinderpersons with cystic fibrosis to whom AtbFinder was used to formulate an individualized antibiotic regimen |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of cystic fibrosis based on sweat chloride levels = or > 60, or genetic testing showing 2 pathogenic mutations.
- Ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment.
- Prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year.
Key exclusion criteria (5 listed)
- Inability to meet any of the above inclusion criteria.
- Systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics.
- Primary or secondary (drug- or condition-induced) immune compromise.
- Creatinine > 2 x upper limit of normal for age.
- Previous participation in this study in the prior 28 days.
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 |
|---|---|---|
| AtbFinderIn the present study, we provided a prospective evaluation of the effectiveness of antibiotics selected with AtbFinder compared to a retrospective analysis of antibiotic efficacy selected with conventional culture-based antibiotic susceptibility tets in patients with cystic fibrosis | Device | AtbFinder-1 |
Primary outcome
Time to an exacerbation (in months)
Time frame: Time Frame: up to 24 months
7 secondary outcomes
Evaluate changes in forced expiratory volume from baseline to end of study
Time frame: Time Frame: up to 24 months
Changes in Pseudomonas aeruginosa load (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
Time frame: Time Frame: up to 24 months
Changes in bacterial load of isolated organisms (the number of colony forming units per 1 ml of sputum) from baseline to end of treatment
Time frame: Time Frame: up to 24 months
Changes in blood white blood cell count (10*9 mg/L)
Time frame: Time Frame: up to 24 months
Changes in blood C-reactive protein (in mg/L)
Time frame: Time Frame: up to 24 months
Changes in weight (in kilograms)
Time frame: Time Frame: up to 24 months
Changes in body mass index calculated as weight (in kilograms) divided by height squared (m2).
Time frame: Time Frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AtbFinder in people with Cystic Fibrosis and Lung Infection Bacterial, run by TGV-Dx.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to an exacerbation (in months) (time frame: Time Frame: up to 24 months). 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 18 Oct 2022.