Lower Respiratory Tract InfectionsNCT01861184
Pneumococcal Carriage in Patients With Lower Respiratory Tract Infection (LRTI)
An observational study of Lower Respiratory Tract Infections, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
We are interested in developing new and better ways of diagnosing the cause of lower respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria or virus) in less than 50% of patients with pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infections
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Nov 2014
- 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: Patients admitted to the hospital with Lower Respiratory Tract Infection
Who may be able to join
- Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker
- Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old
- 10 years of recruited LRTI patient Fluent English speaker
Who cannot join
- Infective exacerbation of COPD or bronchiectasis without consolidation Oxygen saturations <86% on air Tuberculosis suspected Neutropenia
- Signs/symptoms of respiratory infection Oxygen saturations <86% on air Neutropenia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: A Study of Pneumococcal Carriage in Hospitalised Patients With Lower Respiratory Tract Infections
We are interested in developing new and better ways of diagnosing the cause of lower respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria or virus) in less than 50% of patients with pneumonia. A potential way to better find the bug responsible may include checking for bugs in the nose by a nasal wash or swab. Better diagnostics would allow more targeted antibiotic therapy and in the future this technique may be used as a way of checking the efficiency of new vaccines.
We are recruiting both patients with respiratory infections and also a 'control' group of patients admitted to hospital who do not have respiratory infection. We need to have access to your medical history information to make sure you are eligible and suitable for the study. If you participate in the study, it is important that the study doctors continue to have access to your personal Investigator Designation Contact telephone Dr Andrea Collins PhD student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof Stephen Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref: 12/NW/0713 information so you can be followed up properly and so we can contact you during the study if needed.
Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6 teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal Liverpool, in extreme circumstances this will occur at the patient's home).
Read the detailed description
STUDY DESIGN OVERVIEW
Overall research aim
To analyse pneumococcal carriage rates in patients hospitalised with LRTI.
Primary endpoint
Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls.
Secondary endpoints
- Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls
- Alterations of T cell function (Th1, Th17, T regs) in LRTI patients and age matched controls (versus younger adults as part of our existing 'P4' study).
Study design Patients hospitalised with LRTI between November 2012 and April 2014 will be approached within 72 hours of admission.
Patients recruited into the study will consist of those hospitalised with LRTI and a control group of age matched patients (within +/- 10 years) hospitalised for reasons other than respiratory infection.
- Conditions
- Lower Respiratory Tract Infections
- Keywords
- Lower respiratory tract infection, LRTI, Pneumococcal carriage
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 |
|---|---|---|
| LRTI group | Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker | |
| Control group | Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls.
Pneumococcal colonisation will be defined based on the culture (+/-PCR) result of nasal wash/NPS taken at day 0 and 6 weeks.
Measured: 6weeks
Secondary outcomes (1)
Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls
Density will be determined using a modified version of Miles and Misra dilutions.
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Professor Stephen Gordon, Principal investigator, Royal Liverpool University Hospital/ Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861184
- Sponsor's protocol ID
- 100090090
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
German EL, Al-Hakim B, Mitsi E, Pennington SH, Gritzfeld JF, Hyder-Wright AD, Banyard A, Gordon SB, Collins AM, Ferreira DM. Anti-protein immunoglobulin M responses to pneumococcus are not associated with aging. Pneumonia (Nathan). 2018 Jun 5;10:5. doi: 10.1186/s41479-018-0048-3. eCollection 2018.
PubMed 29992080
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pneumococcal Carriage in Hospitalised Patients With Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT01861184
- Acronym / sponsor ID
- 100090090
- Conditions
- Lower Respiratory Tract Infections
- Keywords
- Lower respiratory tract infection, LRTI, Pneumococcal carriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 May 2013 (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.
We are interested in developing new and better ways of diagnosing the cause of lower respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria or virus) in less than 50% of patients with pneumonia. A potential way to better find the bug responsible may include checking for bugs in the nose by a nasal wash or swab. Better diagnostics would allow more targeted antibiotic therapy and in the future this technique may be used as a way of checking the efficiency of new vaccines.
We are recruiting both patients with respiratory infections and also a 'control' group of patients admitted to hospital who do not have respiratory infection. We need to have access to your medical history information to make sure you are eligible and suitable for the study. If you participate in the study, it is important that the study doctors continue to have access to your personal Investigator Designation Contact telephone Dr Andrea Collins PhD student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof Stephen Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref: 12/NW/0713 information so you can be followed up properly and so we can contact you during the study if needed.
Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6 teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal Liverpool, in extreme circumstances this will occur at the patient's home).
Detailed description
STUDY DESIGN OVERVIEW
Overall research aim
To analyse pneumococcal carriage rates in patients hospitalised with LRTI.
Primary endpoint
Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls.
Secondary endpoints
- Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls
- Alterations of T cell function (Th1, Th17, T regs) in LRTI patients and age matched controls (versus younger adults as part of our existing 'P4' study).
Study design Patients hospitalised with LRTI between November 2012 and April 2014 will be approached within 72 hours of admission.
Patients recruited into the study will consist of those hospitalised with LRTI and a control group of age matched patients (within +/- 10 years) hospitalised for reasons other than respiratory infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRTI group | – | –Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker |
| Control group | – | –Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with Lower Respiratory Tract Infection
Key inclusion criteria (3 listed)
- Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker
- Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old
- 10 years of recruited LRTI patient Fluent English speaker
Key exclusion criteria (2 listed)
- Infective exacerbation of COPD or bronchiectasis without consolidation Oxygen saturations <86% on air Tuberculosis suspected Neutropenia
- Signs/symptoms of respiratory infection Oxygen saturations <86% on air Neutropenia
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
Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls.
Time frame: 6weeks
Pneumococcal colonisation will be defined based on the culture (+/-PCR) result of nasal wash/NPS taken at day 0 and 6 weeks.
1 secondary outcome
Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls
Time frame: 6weeks
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 9 Jun 2022.
- Derived from this study: PubMed 29992080German EL, Al-Hakim B, Mitsi E, Pennington SH, Gritzfeld JF, Hyder-Wright AD, Banyard A, Gordon SB, Collins AM, Ferreira DM. Anti-protein immunoglobulin M responses to pneumococcus are not associated with aging. Pneumonia (Nathan). 2018 Jun 5;10:5. doi: 10.1186/s41479-018-0048-3. eCollection 2018.
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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.
Professor Stephen Gordon principal investigator
Royal Liverpool University Hospital/ Liverpool School of Tropical Medicine
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 Lower Respiratory Tract Infections, run by Liverpool University Hospitals NHS Foundation 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 3 inclusion and 2 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 9 Jun 2022. 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?
Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls. (time frame: 6weeks). 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 NCT01861184, which also lists 1 linked publication.
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 9 Jun 2022.