Cystic FibrosisPRIVATENCT04016571
Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Cystic fibrosis (CF) is a multisystem disease characterized by viscid secretions in multiple organ systems. Lung infection and damage account for most of the disease burden. Acute changes in respiratory signs and symptoms termed Pulmonary Exacerbations require treatment with intravenous antibiotics and hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2016to 1 Mar 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a confirmed diagnosis of Cystic Fibrosis being admitted for treatment with intravenous antibiotics for a pulmonary exacerbation using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)
Who may be able to join
- Patients attending the adult service with a confirmed diagnosis of CF by sweat test or genotype
- Able to provide written informed consent
- Able to understand and comply with protocol requirements and instructions
- Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)
Who cannot join
- Previous recipient of a lung or other solid organ transplant
- Inability to complete questionnaires
- Current enrolment in other investigational medicinal product randomised trial
- Admission for reasons other than pulmonary exacerbation of CF
Trial locations and contacts
1 site in 1 country.
About this study
Cystic fibrosis (CF) is a multisystem disease characterized by viscid secretions in multiple organ systems. Lung infection and damage account for most of the disease burden. Acute changes in respiratory signs and symptoms termed Pulmonary Exacerbations require treatment with intravenous antibiotics and hospital admission. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan. Current treatment regimes require improvement but further study is needed to identify who might benefit from a different approach.
This observational study aims to assess if multi-dimensional measurements taken during treatment correspond with later treatment response. This may allow us to personalise treatment more effectively in the future and to better understand how individuals respond to treatment.
Read the detailed description
Pulmonary Exacerbations in CF require treatment with intravenous (IV) antibiotics and hospital admission for between 10-21 days. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan.Robust evidence to support current treatment approaches is lacking with awareness that current regimes could be optimised.
As yet there is no model for predicting how patients with CF will respond to IV antibiotic treatment- other than clinical judgement and lung function response.This is due to lack of robust measures to identify clinical response at the time of treatment and safely predict later clinical outcomes. The heterogeneity of the 21st Century CF population means a multi-dimensional composite measure is needed. This study has therefore been designed to provide an overall picture of people's response including clinical, biochemical and patient related outcome measures. Using multi-dimensional assessment we hope the measures assessed in this study will give a better picture of how people feel and how they respond to treatment.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pulmonary Exacerbation, Antibiotics, Outcome measures
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Cystic Fibrosis | All Adults with a confirmed diagnosis of Cystic Fibrosis being admitted for Intra-Venous Antibiotic Treatment of a Pulmonary Exacerbation This study is observational so no intervention will be carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Lung function Measure
Measured: Change in lung function between baseline and day 0, Day 5 and Day 14 of treatment
Secondary outcomes (10)
Treatment Failure defined by need for further IV antibiotic treatment within 30 days
The number of participants requiring a further course of IV antibiotics within 30 days
Measured: Need for a further course of IV antibiotics within 30 days of treatment completion
Change in Respiratory Symptoms
Change in Respiratory Symptoms assessed by CF-Respiratory Symptom Diary
Measured: Change between Day 0, day 5 and day 14 of treatment
Physical activity levels (step count, distance walked, Lightly active minutes, Moderate velocity physical activity (MVPA) and Exercise)
Change in Physical Activity Levels measured by consumable wearable device
Measured: Change between Day 0, day 5 and day 14 of treatment
Sleep parameters measured by consumable wearable device
Change in time in bed, time asleep and time awake/restless (mins)
Measured: Change between Day 0, day 5 and day 14 of treatment
Change in serum inflammatory marker (C-Reactive Protein)
Change in serum inflammatory marker (CRP)
Measured: Change between Day 0, day 5 and day 14 of treatment
Change in sputum inflammatory markers
Change in sputum (Interleukins, Tumour Necrosis Factor-Alpha, Calprotectin and Human Mobility Growth Box Protein -1) inflammatory markers (measured in pg/ml)
Measured: Change between Day 0, day 5 and day 14 of treatment
Change in microbiological growth measured by culture
Change in microbiological growth measured by culture
Measured: Change between Day 0, day 5 and day 14 of treatment
Change in microbiological community composition measured by microbiota analysis
Change in microbiological relative abundance, dominance, evenness, diversity and richness
Measured: Change between Day 0, day 5 and day 14 of treatment
Change in 24 hour sputum volume
Change in 24 hour sputum volume (mls)
Measured: Change between Day 0, day 5 and day 14 of treatment
Time to next exacerbation
Time to next exacerbation
Measured: Time to next course of intravenous antibiotics within 12 month follow up period (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Dec 2016
- Primary completion10 Aug 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast
- Responsible party
- Sponsor
- Investigators
- Damian Dr Downey, MBBS MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016571
- Sponsor's protocol ID
- IRAS 210802
- Acronym
- PRIVATE
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to maintain confidentiality
Publications
Heltshe SL, Goss CH, Thompson V, Sagel SD, Sanders DB, Marshall BC, Flume PA. Short-term and long-term response to pulmonary exacerbation treatment in cystic fibrosis. Thorax. 2016 Mar;71(3):223-9. doi: 10.1136/thoraxjnl-2014-206750. Epub 2015 Apr 24.
PubMed 25911223Britto MT, Kotagal UR, Hornung RW, Atherton HD, Tsevat J, Wilmott RW. Impact of recent pulmonary exacerbations on quality of life in patients with cystic fibrosis. Chest. 2002 Jan;121(1):64-72. doi: 10.1378/chest.121.1.64.
PubMed 11796433de Boer K, Vandemheen KL, Tullis E, Doucette S, Fergusson D, Freitag A, Paterson N, Jackson M, Lougheed MD, Kumar V, Aaron SD. Exacerbation frequency and clinical outcomes in adult patients with cystic fibrosis. Thorax. 2011 Aug;66(8):680-5. doi: 10.1136/thx.2011.161117. Epub 2011 Jun 15.
PubMed 21680566VanDevanter DR, Pasta DJ, Konstan MW. Treatment and demographic factors affecting time to next pulmonary exacerbation in cystic fibrosis. J Cyst Fibros. 2015 Nov;14(6):763-9. doi: 10.1016/j.jcf.2015.02.007. Epub 2015 Mar 6.
PubMed 25754096Sanders DB, Bittner RC, Rosenfeld M, Hoffman LR, Redding GJ, Goss CH. Failure to recover to baseline pulmonary function after cystic fibrosis pulmonary exacerbation. Am J Respir Crit Care Med. 2010 Sep 1;182(5):627-32. doi: 10.1164/rccm.200909-1421OC. Epub 2010 May 12.
PubMed 20463179Flume PA, Mogayzel PJ Jr, Robinson KA, Goss CH, Rosenblatt RL, Kuhn RJ, Marshall BC; Clinical Practice Guidelines for Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: treatment of pulmonary exacerbations. Am J Respir Crit Care Med. 2009 Nov 1;180(9):802-8. doi: 10.1164/rccm.200812-1845PP. Epub 2009 Sep 3.
PubMed 19729669VanDevanter DR, O'Riordan MA, Blumer JL, Konstan MW. Assessing time to pulmonary function benefit following antibiotic treatment of acute cystic fibrosis exacerbations. Respir Res. 2010 Oct 6;11(1):137. doi: 10.1186/1465-9921-11-137.
PubMed 20925941Collaco JM, Green DM, Cutting GR, Naughton KM, Mogayzel PJ Jr. Location and duration of treatment of cystic fibrosis respiratory exacerbations do not affect outcomes. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1137-43. doi: 10.1164/rccm.201001-0057OC. Epub 2010 Jun 25.
PubMed 20581166Smith DJ, Badrick AC, Zakrzewski M, Krause L, Bell SC, Anderson GJ, Reid DW. Pyrosequencing reveals transient cystic fibrosis lung microbiome changes with intravenous antibiotics. Eur Respir J. 2014 Oct;44(4):922-30. doi: 10.1183/09031936.00203013. Epub 2014 Jul 17.
PubMed 25034564Heltshe SL, Goss CH. Optimising treatment of CF pulmonary exacerbation: a tough nut to crack. Thorax. 2016 Feb;71(2):101-2. doi: 10.1136/thoraxjnl-2015-208057. No abstract available.
PubMed 26769012Shoki AH, Mayer-Hamblett N, Wilcox PG, Sin DD, Quon BS. Systematic review of blood biomarkers in cystic fibrosis pulmonary exacerbations. Chest. 2013 Nov;144(5):1659-1670. doi: 10.1378/chest.13-0693.
PubMed 23868694McCourt F, O'Neill B, Logan I, Abbott J, Plant B, McCrum-Gardner E, McKeown S, Stuart Elborn J, Bradley JM. Indicators of pulmonary exacerbation in cystic fibrosis: A Delphi survey of patients and health professionals. J Cyst Fibros. 2015 Jan;14(1):90-6. doi: 10.1016/j.jcf.2014.06.007. Epub 2014 Aug 12.
PubMed 25127921Goss CH, Edwards TC, Ramsey BW, Aitken ML, Patrick DL. Patient-reported respiratory symptoms in cystic fibrosis. J Cyst Fibros. 2009 Jul;8(4):245-52. doi: 10.1016/j.jcf.2009.04.003. Epub 2009 May 29.
PubMed 19481983
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04016571
- Acronym / sponsor ID
- PRIVATE / IRAS 210802
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pulmonary Exacerbation, Antibiotics, Outcome measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 11 Jul 2019 (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.
Cystic fibrosis (CF) is a multisystem disease characterized by viscid secretions in multiple organ systems. Lung infection and damage account for most of the disease burden. Acute changes in respiratory signs and symptoms termed Pulmonary Exacerbations require treatment with intravenous antibiotics and hospital admission. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan. Current treatment regimes require improvement but further study is needed to identify who might benefit from a different approach.
This observational study aims to assess if multi-dimensional measurements taken during treatment correspond with later treatment response. This may allow us to personalise treatment more effectively in the future and to better understand how individuals respond to treatment.
Detailed description
Pulmonary Exacerbations in CF require treatment with intravenous (IV) antibiotics and hospital admission for between 10-21 days. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan.Robust evidence to support current treatment approaches is lacking with awareness that current regimes could be optimised.
As yet there is no model for predicting how patients with CF will respond to IV antibiotic treatment- other than clinical judgement and lung function response.This is due to lack of robust measures to identify clinical response at the time of treatment and safely predict later clinical outcomes. The heterogeneity of the 21st Century CF population means a multi-dimensional composite measure is needed. This study has therefore been designed to provide an overall picture of people's response including clinical, biochemical and patient related outcome measures. Using multi-dimensional assessment we hope the measures assessed in this study will give a better picture of how people feel and how they respond to treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Cystic Fibrosis | – | –All Adults with a confirmed diagnosis of Cystic Fibrosis being admitted for Intra-Venous Antibiotic Treatment of a Pulmonary Exacerbation This study is observational so no intervention will be carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a confirmed diagnosis of Cystic Fibrosis being admitted for treatment with intravenous antibiotics for a pulmonary exacerbation using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)
Key inclusion criteria (4 listed)
- Patients attending the adult service with a confirmed diagnosis of CF by sweat test or genotype
- Able to provide written informed consent
- Able to understand and comply with protocol requirements and instructions
- Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)
Key exclusion criteria (4 listed)
- Previous recipient of a lung or other solid organ transplant
- Inability to complete questionnaires
- Current enrolment in other investigational medicinal product randomised trial
- Admission for reasons other than pulmonary exacerbation of CF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Change in lung function between baseline and day 0, Day 5 and Day 14 of treatment
Lung function Measure
10 secondary outcomes
Treatment Failure defined by need for further IV antibiotic treatment within 30 days
Time frame: Need for a further course of IV antibiotics within 30 days of treatment completion
Change in Respiratory Symptoms
Time frame: Change between Day 0, day 5 and day 14 of treatment
Physical activity levels (step count, distance walked, Lightly active minutes, Moderate velocity physical activity (MVPA) and Exercise)
Time frame: Change between Day 0, day 5 and day 14 of treatment
Sleep parameters measured by consumable wearable device
Time frame: Change between Day 0, day 5 and day 14 of treatment
Change in serum inflammatory marker (C-Reactive Protein)
Time frame: Change between Day 0, day 5 and day 14 of treatment
Change in sputum inflammatory markers
Time frame: Change between Day 0, day 5 and day 14 of treatment
Change in microbiological growth measured by culture
Time frame: Change between Day 0, day 5 and day 14 of treatment
Change in microbiological community composition measured by microbiota analysis
Time frame: Change between Day 0, day 5 and day 14 of treatment
Change in 24 hour sputum volume
Time frame: Change between Day 0, day 5 and day 14 of treatment
Time to next exacerbation
Time frame: Time to next course of intravenous antibiotics within 12 month follow up period (study end)
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 5 Aug 2020.
- Background: PubMed 25911223Heltshe SL, Goss CH, Thompson V, Sagel SD, Sanders DB, Marshall BC, Flume PA. Short-term and long-term response to pulmonary exacerbation treatment in cystic fibrosis. Thorax. 2016 Mar;71(3):223-9. doi: 10.1136/thoraxjnl-2014-206750. Epub 2015 Apr 24.
- Background: PubMed 11796433Britto MT, Kotagal UR, Hornung RW, Atherton HD, Tsevat J, Wilmott RW. Impact of recent pulmonary exacerbations on quality of life in patients with cystic fibrosis. Chest. 2002 Jan;121(1):64-72. doi: 10.1378/chest.121.1.64.
- Background: PubMed 21680566de Boer K, Vandemheen KL, Tullis E, Doucette S, Fergusson D, Freitag A, Paterson N, Jackson M, Lougheed MD, Kumar V, Aaron SD. Exacerbation frequency and clinical outcomes in adult patients with cystic fibrosis. Thorax. 2011 Aug;66(8):680-5. doi: 10.1136/thx.2011.161117. Epub 2011 Jun 15.
- Background: PubMed 25754096VanDevanter DR, Pasta DJ, Konstan MW. Treatment and demographic factors affecting time to next pulmonary exacerbation in cystic fibrosis. J Cyst Fibros. 2015 Nov;14(6):763-9. doi: 10.1016/j.jcf.2015.02.007. Epub 2015 Mar 6.
- Background: PubMed 20463179Sanders DB, Bittner RC, Rosenfeld M, Hoffman LR, Redding GJ, Goss CH. Failure to recover to baseline pulmonary function after cystic fibrosis pulmonary exacerbation. Am J Respir Crit Care Med. 2010 Sep 1;182(5):627-32. doi: 10.1164/rccm.200909-1421OC. Epub 2010 May 12.
- Background: PubMed 19729669Flume PA, Mogayzel PJ Jr, Robinson KA, Goss CH, Rosenblatt RL, Kuhn RJ, Marshall BC; Clinical Practice Guidelines for Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: treatment of pulmonary exacerbations. Am J Respir Crit Care Med. 2009 Nov 1;180(9):802-8. doi: 10.1164/rccm.200812-1845PP. Epub 2009 Sep 3.
- Background: PubMed 20925941VanDevanter DR, O'Riordan MA, Blumer JL, Konstan MW. Assessing time to pulmonary function benefit following antibiotic treatment of acute cystic fibrosis exacerbations. Respir Res. 2010 Oct 6;11(1):137. doi: 10.1186/1465-9921-11-137.
- Background: PubMed 20581166Collaco JM, Green DM, Cutting GR, Naughton KM, Mogayzel PJ Jr. Location and duration of treatment of cystic fibrosis respiratory exacerbations do not affect outcomes. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1137-43. doi: 10.1164/rccm.201001-0057OC. Epub 2010 Jun 25.
- Background: PubMed 25034564Smith DJ, Badrick AC, Zakrzewski M, Krause L, Bell SC, Anderson GJ, Reid DW. Pyrosequencing reveals transient cystic fibrosis lung microbiome changes with intravenous antibiotics. Eur Respir J. 2014 Oct;44(4):922-30. doi: 10.1183/09031936.00203013. Epub 2014 Jul 17.
- Background: PubMed 26769012Heltshe SL, Goss CH. Optimising treatment of CF pulmonary exacerbation: a tough nut to crack. Thorax. 2016 Feb;71(2):101-2. doi: 10.1136/thoraxjnl-2015-208057. No abstract available.
- Background: PubMed 23868694Shoki AH, Mayer-Hamblett N, Wilcox PG, Sin DD, Quon BS. Systematic review of blood biomarkers in cystic fibrosis pulmonary exacerbations. Chest. 2013 Nov;144(5):1659-1670. doi: 10.1378/chest.13-0693.
- Background: PubMed 25127921McCourt F, O'Neill B, Logan I, Abbott J, Plant B, McCrum-Gardner E, McKeown S, Stuart Elborn J, Bradley JM. Indicators of pulmonary exacerbation in cystic fibrosis: A Delphi survey of patients and health professionals. J Cyst Fibros. 2015 Jan;14(1):90-6. doi: 10.1016/j.jcf.2014.06.007. Epub 2014 Aug 12.
- Individual participant dataSharing planned: No. No individual participant data will be made available to maintain confidentiality
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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.
Damian Dr Downey, MBBS MD principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: Change in lung function between baseline and day 0, Day 5 and Day 14 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016571, which also lists 13 linked publications.
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 5 Aug 2020.