Cystic FibrosisNCT01306279
The Infective Pulmonary Exacerbations in Cystic Fibrosis - an Ecological Perspective
An observational study of Cystic Fibrosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Given the treatment burden and excess morbidity and mortality associated with acute infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the origins of an infective exacerbation and the response to antibiotics is vital to improving long-term outcomes in CF. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Aug 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with Cystic Fibrosis attending to commence intravenous antibiotics for a pulmonary exacerbation of CF
Who may be able to join
- Confirmed diagnosis of Cystic Fibrosis
- Chronic Pseudomonas aeruginosa
- Symptoms and signs of infective exacerbation
Who cannot join
- age under 16
- unable to give consent or patients with significant mental health problems
- co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy
- a previous participant in this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cystic Fibrosis, NHLI, Imperial College,
London, London, SW3 6NP
About this study
Given the treatment burden and excess morbidity and mortality associated with acute infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the origins of an infective exacerbation and the response to antibiotics is vital to improving long-term outcomes in CF.
This study will examine 3 areas of interest in CF exacerbations.
Read more
- Bacterial biodiversity and its clinical significance
- The role of bacteria which are able to rapidly mutate (hypermutators)
- Inter-bacterial communication and its role in infective exacerbations
Study Hypothesis 1
Increased microbiological diversity represents a balanced community of bacteria. The presence of a diverse population of bacteria in CF infections therefore predicts a better outcome for treatment than when a population consists of a small number of more virulent organisms.
Study Hypothesis 2
Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under stress, such as during antibiotic treatment or during an infection. They are, however, weaker organisms because of the multiple mutations they have undergone. Their presence does not relate to clinical outcome but may be associated with the emergence of antibiotic resistance.
Study Hypothesis 3
Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill this population of bacteria and QS molecule levels drop in the lung, patients recover from infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels to remain elevated and patients to have prolonged infections.
Read the detailed description
We will sequentially recruit patients attending our CF centre with an infective exacerbation of CF, who are chronically infected with Pseudomonas aeruginosa.
We will record spirometry, blood markers of inflammation, quality of life questionnaires and investigate sputum samples for:
- Routine microbiology
- Bacterial diversity using 16s RNA identification techniques
- Relative abundance of P.aeruginosa hypermutators
- Levels of quorum sensing molecules
These observations will be undertaken before commencing intravenous antibiotic therapy, on days 7, 10 and the last day of antibiotic therapy. Patients will also be reviewed one month after the end of antibiotic therapy where spirometry and a sputum sample will be collected for the above investigations.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Infection, Pulmonary exacerbation, Hypermutators, Bacterial diversity, Quorum sensing
- Medical subject headings
- Cystic Fibrosis, Infections
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 |
|---|---|---|
| Cystic Fibrosis, infection | Cystic Fibrosis patients with an infective exacerbation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
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 Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Hodson, MD MSc FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306279
- Sponsor's protocol ID
- 11/H0713/7
- Status last verified
- Mar 2013
- First submitted
- 28 Feb 2011
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Infective Pulmonary Exacerbations in Cystic Fibrosis - an Ecological Perspective
- ClinicalTrials.gov ID
- NCT01306279
- Acronym / sponsor ID
- 11/H0713/7
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Infection, Pulmonary exacerbation, Hypermutators, Bacterial diversity, Quorum sensing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- First posted
- 1 Mar 2011 (estimated)
- 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.
Given the treatment burden and excess morbidity and mortality associated with acute infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the origins of an infective exacerbation and the response to antibiotics is vital to improving long-term outcomes in CF.
This study will examine 3 areas of interest in CF exacerbations.
- Bacterial biodiversity and its clinical significance
- The role of bacteria which are able to rapidly mutate (hypermutators)
- Inter-bacterial communication and its role in infective exacerbations
Study Hypothesis 1
Increased microbiological diversity represents a balanced community of bacteria. The presence of a diverse population of bacteria in CF infections therefore predicts a better outcome for treatment than when a population consists of a small number of more virulent organisms.
Study Hypothesis 2
Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under stress, such as during antibiotic treatment or during an infection. They are, however, weaker organisms because of the multiple mutations they have undergone. Their presence does not relate to clinical outcome but may be associated with the emergence of antibiotic resistance.
Study Hypothesis 3
Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill this population of bacteria and QS molecule levels drop in the lung, patients recover from infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels to remain elevated and patients to have prolonged infections.
Detailed description
We will sequentially recruit patients attending our CF centre with an infective exacerbation of CF, who are chronically infected with Pseudomonas aeruginosa.
We will record spirometry, blood markers of inflammation, quality of life questionnaires and investigate sputum samples for:
- Routine microbiology
- Bacterial diversity using 16s RNA identification techniques
- Relative abundance of P.aeruginosa hypermutators
- Levels of quorum sensing molecules
These observations will be undertaken before commencing intravenous antibiotic therapy, on days 7, 10 and the last day of antibiotic therapy. Patients will also be reviewed one month after the end of antibiotic therapy where spirometry and a sputum sample will be collected for the above investigations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis, infection | – | –Cystic Fibrosis patients with an infective exacerbation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with Cystic Fibrosis attending to commence intravenous antibiotics for a pulmonary exacerbation of CF
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Cystic Fibrosis
- Chronic Pseudomonas aeruginosa
- Symptoms and signs of infective exacerbation
Key exclusion criteria (4 listed)
- age under 16
- unable to give consent or patients with significant mental health problems
- co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy
- a previous participant in this study
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
Not reported in the source record.
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 21 Mar 2016.
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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.
Margaret Hodson, MD MSc FRCP principal investigator
Imperial College London
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 Imperial College London 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 3 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 21 Mar 2016. 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.
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 21 Mar 2016.