Respiratory Tract InfectionsNCT04595526
Optimal Collection of Specimens of the Lower Respiratory Tract
A study testing Forced expiratory technique and induced sputum and Tracheal suction in people with Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Respiratory tract infection is a serious condition causing 3 million deaths worldwide every year. Approximately 20-40% of patients with community-acquired pneumonia are hospitalised. Treatment of pneumonia should be initiated as quickly as possible and therefore an early and precise diagnostic is extremely important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Forced expiratory technique and induced sputum and Tracheal suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Nov 2020to 5 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with suspected lower respiratory tract infection
- Patients > 18 years old
- One of the following symptoms: dyspnea, cough, expectoration, fever and chest tightness
Who cannot join
- Patients transferred directly to ICU
- If the attending physician considers emergency treatment is needed
- Patients receiving prednisolone treatment of 20mg/day or more over the last 2 weeks
- Patient which consent cannot be obtained
Trial locations and contacts
1 site in 1 country.
About this study
Respiratory tract infection is a serious condition causing 3 million deaths worldwide every year. Approximately 20-40% of patients with community-acquired pneumonia are hospitalised. Treatment of pneumonia should be initiated as quickly as possible and therefore an early and precise diagnostic is extremely important. Imprecise or delayed diagnosis often results in overconsumption of broad-spectrum antibiotics that contribute to the development of antibiotic resistance. Unspecific symptoms, unsure diagnosis methods and a wait time of up to several days for results challenge a quick and effective diagnosis and treatment of pneumonia. Microbiological analysis of sputum samples is used to identify pathogens causative to pneumonia. However, obtaining specimens of good quality is challenging and affects the sensitivity and specificity of the results. Therefore, the identification of the optimal sputum collecting method is needed to ensure an improved identification process of the pathogen causing pneumonia.
The purpose of this study is to determine the most optimal method for obtaining good quality sputum samples when comparing tracheal suction to methods without suction. A more accurate diagnosis will lead to more appropriate antibiotic consumption and will reduce the general development of antibiotic resistance.
Read the detailed description
Multi-resistant bacteria (MRB) are associated with high antibiotic consumption and designated by WHO as one of the major threats to the world. In Denmark, the incidence of MRB is generally increasing, and every 20th patient admitted to Danish Emergency Department (ED), is infected with resistant bacteria. Respiratory tract infection is a serious condition, with 3 million death worldwide every year, and about 20-40% of the patients with community-acquired pneumonia need hospitalization. Data from the ED at Hospital Sønderjylland shows that 6% of the patients are registered with a respiratory tract infection, including pneumonia. Treatment of pneumonia should be initiated within a few hours, therefore early and precise diagnostic is extremely important. An imprecise or delayed diagnostic will often result in overconsumption of broad-spectrum antibiotics, contributing to an increase in the development of MRB threatening future treatments possibilities. Currently, pneumonia diagnosis is based on clinical symptoms such as cough, expectoration, chest pain, fever or breathlessness, combined with an x-ray of the lungs, relevant blood tests and microbiological analyses of sputum samples. However, X-ray is an imprecise diagnostic tool, and sputum test responses are first available after 2 days. Thus, the diagnostic is challenged by unspecific symptoms, unsure diagnostic methods and prolonged waiting time for results of up to several days. Sputum can be cultivated to determine the bacterial agent. However, the sputum samples are often of poor quality and many patients cannot deliver a sample. A recently published Danish study shows, that only half of the patients at the ED have sputum samples collected for culturing and none of them had their antibiotic treatment adjusted based on the microbiological results of the sputum. Despite, the use of different microbiological analysis methods to detect bacteria or virus causative of pneumonia, common to the methods is that a representative specimen from the lower respiratory tract is crucial for optimal sensitivity and specificity. Despite technological advances in molecular diagnostics, identifying the etiology of pneumonia remains a challenge. Consequently, identification of optimal sputum collecting method and investigation of an alternative sputum analyses assessment is needed to improve specimens' suitability to identify the etiology of pneumonia.
Clinical experience indicates that an inhalation mask with saline solution can induce a successful sputum sampling. Tracheal suction is often used on intubated patients in the intensive care unit to collect sputum, and this method has become the standard procedure at several ED. A comparison of the two methods has not been investigated in an ED context nor has the quality of the collected sputum samples and relevance for clinical practice been explored.
Ensuring the optimal sputum collection is of particular relevance during the COVID-19 pandemic. An optimal sputum collection is important to be able to determine if the pneumonia is caused by SARS-CoV-2 or a bacterium - especially in situations where the swab from throat or pharynx presents a negative result, as the method is not sensitive enough to rule out COVID-19 in patients with pneumonia. Accordingly, the Health Board in Denmark recommends tracheal suction of patients admitted with suspected COVID-19 in case of symptoms of the lower respiratory tract, and only in cases the symptoms originates from the upper airways a swab can be performed
1.1 Hypothesis and purpose The hypotheses is that methods without suction (forced expiratory technique and induced sputum) are just as effective as tracheal suction for obtaining a representative specimen from the lower respiratory tract..
The purpose of this study is to determine the most optimal method for obtaining high-quality sputum samples.
Following research questions will be explored:
- What is the difference between the conventional sampling by tracheal suction comparing to sampling using forced expiratory or induced sputum techniques in relation to the suitability of collected specimens from the lower respiratory tract
- Identification of possible adverse events during sputum collection
- How do patients experience the two sputum sample collecting procedures?
Collection of sputum and adverse events After consent, the patient will be randomized in two groups with 1:1 allocation using permuting blocks. The software tool 'Randomized' offered by Open Patient data Explorative Network (OPEN) will be used.
ORGANIZATION The project is anchored in the Research unit of Emergency Medicine, the ED of Hospital Sønderjylland and the Department of Regional Health Research, University of Southern Denmark. The project is a research collaboration between clinicians and researchers in the field of emergency medicine and microbiology at Hospital Sønderjylland (SHS) and Odense University Hospital (OUH).
- Conditions
- Respiratory Tract Infections
- Being tested
- Forced expiratory technique and induced sputum, Tracheal suction
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced expiratory technique and induced sputumProcedure or surgery
The intervention is based on the patient's own attempt to deliver a sputum sample after instructions of proper huff forced exhalation and coughing technique. After an attempt to deliver a sputum sample the patient will receive a 0,9% isotonic saline by an inhalation mask to induce the sputum, thereafter the patient will again make an effort to expectorate a sputum sample repeating the forced expiratory technique.
Tracheal suctionProcedure or surgery
Tracheal suction is often used on intubated patients at the intensive care unit to collect sputum, and this method has become the standard procedure at several emergency departments.
| Study group | Role | What they receive |
|---|---|---|
| Tracheal suction | Active comparator | Uses the local standard procedure of tracheal suction to obtain secretions from the lower respiratory tract Receives: Procedure: Tracheal suction |
| Forced expiratory technique and induced sputum | Experimental | This procedure is without suction. The patient's attempts to deliver a sputum sample after forced exhalation and coughing technique. Regardless of the result the patient then receives hypertonic saline by an inhalation mask to induce the sputum. If the patient cannot deliver a sample, tracheal suction will be performed in order to obtain a specimen for the analyses. Receives: Procedure: Forced expiratory technique and induced sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of specimen from the lower respiratory tract
Unsuitable (bad quality) measured by microscopy - > 10 squamous epithelial cells per low power field of view (x10). Suitable (good quality) measured by microscopy - Samples with < 10 squamous epithelial cells per low power field of view
Measured: From collection to culture results - up to 5 days
Secondary outcomes (8)
Patient clinical symptoms
The patients are asked about 4 specific symptoms (Cough, Expectoration, Chest pain and Dyspnea). The clinical symptoms are measured as following: yes/no/yes worse than usual. Ten minutes after the intervention they will be asked the same questions with yes/no/worse than before the intervention.
Measured: Patients are followed before intervention and 10 minutes after intervention
Respiratory rate
This will be counted by the health professional attending the patient and is the number of breaths per minute in rest. It is assessed by counting the number of times the patients chest rises in a half minute multiplied by 2.
Measured: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Oxygen saturation
This is measured using a pulse oximetry device - a non-invasive method to measure arterial oxygen saturation level in percentages
Measured: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Patient well-being and experience of procedure
Measured using the Borg Categorical rate 10 scale and a single likert-scale question - 'How does the patient experience the procedure' (only measured after the intervention).
Measured: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Occurrence of side effects
Project assistants will register any side effects such as bleeding from the airways and bronchospasm.
Measured: Registered up to 1 hour after intervention
Short term mortality
Death within 7 days from hospital admission
Measured: Registered within 7 days from hospital admission
Number of patients readmitted to hospital
30 days readmission after current hospitalization
Measured: Registered within 1 month after readmission
Patient experience of sputum collection
This outcome will be measured once after an attempt at sputum collection. A five-point Likert scale ranging from "very bad, bad, neither bad nor good, good, very good" will be used to report how the patient experienced the procedure.
Measured: Measured 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start9 Nov 2020
- Primary completion5 Jul 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Backer Mogensen, MD PhD, Study chair, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595526
- Sponsor's protocol ID
- SHS-ED-08-2020
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Overend TJ, Anderson CM, Brooks D, Cicutto L, Keim M, McAuslan D, Nonoyama M. Updating the evidence-base for suctioning adult patients: a systematic review. Can Respir J. 2009 May-Jun;16(3):e6-17. doi: 10.1155/2009/872921.
PubMed 19557211Skjot-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Moller JM, Ludwig M, Fuglsang-Damgaard D, Nielsen FE, Petersen DB, Jensen US, Rosenvinge FS. Carrier prevalence and risk factors for colonisation of multiresistant bacteria in Danish emergency departments: a cross-sectional survey. BMJ Open. 2019 Jun 27;9(6):e029000. doi: 10.1136/bmjopen-2019-029000.
PubMed 31253624Meehan TP, Fine MJ, Krumholz HM, Scinto JD, Galusha DH, Mockalis JT, Weber GF, Petrillo MK, Houck PM, Fine JM. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997 Dec 17;278(23):2080-4.
PubMed 9403422Karakioulaki M, Stolz D. Biomarkers and clinical scoring systems in community-acquired pneumonia. Ann Thorac Med. 2019 Jul-Sep;14(3):165-172. doi: 10.4103/atm.ATM_305_18.
PubMed 31333765Savvateeva EN, Rubina AY, Gryadunov DA. Biomarkers of Community-Acquired Pneumonia: A Key to Disease Diagnosis and Management. Biomed Res Int. 2019 Apr 30;2019:1701276. doi: 10.1155/2019/1701276. eCollection 2019.
PubMed 31183362Saukkoriipi A, Palmu AA, Jokinen J. Culture of all sputum samples irrespective of quality adds value to the diagnosis of pneumococcal community-acquired pneumonia in the elderly. Eur J Clin Microbiol Infect Dis. 2019 Jul;38(7):1249-1254. doi: 10.1007/s10096-019-03536-9. Epub 2019 Apr 4.
PubMed 30949897Miyashita N, Shimizu H, Ouchi K, Kawasaki K, Kawai Y, Obase Y, Kobashi Y, Oka M. Assessment of the usefulness of sputum Gram stain and culture for diagnosis of community-acquired pneumonia requiring hospitalization. Med Sci Monit. 2008 Apr;14(4):CR171-6.
PubMed 18376343Murdoch DR. How best to determine causative pathogens of pneumonia. Pneumonia (Nathan). 2016 Apr 12;8:1. doi: 10.1186/s41479-016-0004-z. eCollection 2016.
PubMed 28702281Herrero-Cortina B, Alcaraz V, Vilaro J, Torres A, Polverino E. Impact of Hypertonic Saline Solutions on Sputum Expectoration and Their Safety Profile in Patients with Bronchiectasis: A Randomized Crossover Trial. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):281-289. doi: 10.1089/jamp.2017.1443. Epub 2018 Jun 7.
PubMed 29878856Cartuliares MB, Skjot-Arkil H, Rosenvinge FS, Mogensen CB, Skovsted TA, Pedersen AK. Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial. Trials. 2021 Oct 2;22(1):675. doi: 10.1186/s13063-021-05639-1.
PubMed 34600559
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Collection of Specimens of the Lower Respiratory Tract
- ClinicalTrials.gov ID
- NCT04595526
- Acronym / sponsor ID
- SHS-ED-08-2020
- Conditions
- Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 20 Oct 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.
Respiratory tract infection is a serious condition causing 3 million deaths worldwide every year. Approximately 20-40% of patients with community-acquired pneumonia are hospitalised. Treatment of pneumonia should be initiated as quickly as possible and therefore an early and precise diagnostic is extremely important. Imprecise or delayed diagnosis often results in overconsumption of broad-spectrum antibiotics that contribute to the development of antibiotic resistance. Unspecific symptoms, unsure diagnosis methods and a wait time of up to several days for results challenge a quick and effective diagnosis and treatment of pneumonia. Microbiological analysis of sputum samples is used to identify pathogens causative to pneumonia. However, obtaining specimens of good quality is challenging and affects the sensitivity and specificity of the results. Therefore, the identification of the optimal sputum collecting method is needed to ensure an improved identification process of the pathogen causing pneumonia.
The purpose of this study is to determine the most optimal method for obtaining good quality sputum samples when comparing tracheal suction to methods without suction. A more accurate diagnosis will lead to more appropriate antibiotic consumption and will reduce the general development of antibiotic resistance.
Detailed description
Multi-resistant bacteria (MRB) are associated with high antibiotic consumption and designated by WHO as one of the major threats to the world. In Denmark, the incidence of MRB is generally increasing, and every 20th patient admitted to Danish Emergency Department (ED), is infected with resistant bacteria. Respiratory tract infection is a serious condition, with 3 million death worldwide every year, and about 20-40% of the patients with community-acquired pneumonia need hospitalization. Data from the ED at Hospital Sønderjylland shows that 6% of the patients are registered with a respiratory tract infection, including pneumonia. Treatment of pneumonia should be initiated within a few hours, therefore early and precise diagnostic is extremely important. An imprecise or delayed diagnostic will often result in overconsumption of broad-spectrum antibiotics, contributing to an increase in the development of MRB threatening future treatments possibilities. Currently, pneumonia diagnosis is based on clinical symptoms such as cough, expectoration, chest pain, fever or breathlessness, combined with an x-ray of the lungs, relevant blood tests and microbiological analyses of sputum samples. However, X-ray is an imprecise diagnostic tool, and sputum test responses are first available after 2 days. Thus, the diagnostic is challenged by unspecific symptoms, unsure diagnostic methods and prolonged waiting time for results of up to several days. Sputum can be cultivated to determine the bacterial agent. However, the sputum samples are often of poor quality and many patients cannot deliver a sample. A recently published Danish study shows, that only half of the patients at the ED have sputum samples collected for culturing and none of them had their antibiotic treatment adjusted based on the microbiological results of the sputum. Despite, the use of different microbiological analysis methods to detect bacteria or virus causative of pneumonia, common to the methods is that a representative specimen from the lower respiratory tract is crucial for optimal sensitivity and specificity. Despite technological advances in molecular diagnostics, identifying the etiology of pneumonia remains a challenge. Consequently, identification of optimal sputum collecting method and investigation of an alternative sputum analyses assessment is needed to improve specimens' suitability to identify the etiology of pneumonia.
Clinical experience indicates that an inhalation mask with saline solution can induce a successful sputum sampling. Tracheal suction is often used on intubated patients in the intensive care unit to collect sputum, and this method has become the standard procedure at several ED. A comparison of the two methods has not been investigated in an ED context nor has the quality of the collected sputum samples and relevance for clinical practice been explored.
Ensuring the optimal sputum collection is of particular relevance during the COVID-19 pandemic. An optimal sputum collection is important to be able to determine if the pneumonia is caused by SARS-CoV-2 or a bacterium - especially in situations where the swab from throat or pharynx presents a negative result, as the method is not sensitive enough to rule out COVID-19 in patients with pneumonia. Accordingly, the Health Board in Denmark recommends tracheal suction of patients admitted with suspected COVID-19 in case of symptoms of the lower respiratory tract, and only in cases the symptoms originates from the upper airways a swab can be performed
1.1 Hypothesis and purpose The hypotheses is that methods without suction (forced expiratory technique and induced sputum) are just as effective as tracheal suction for obtaining a representative specimen from the lower respiratory tract..
The purpose of this study is to determine the most optimal method for obtaining high-quality sputum samples.
Following research questions will be explored:
- What is the difference between the conventional sampling by tracheal suction comparing to sampling using forced expiratory or induced sputum techniques in relation to the suitability of collected specimens from the lower respiratory tract
- Identification of possible adverse events during sputum collection
- How do patients experience the two sputum sample collecting procedures?
Collection of sputum and adverse events After consent, the patient will be randomized in two groups with 1:1 allocation using permuting blocks. The software tool 'Randomized' offered by Open Patient data Explorative Network (OPEN) will be used.
ORGANIZATION The project is anchored in the Research unit of Emergency Medicine, the ED of Hospital Sønderjylland and the Department of Regional Health Research, University of Southern Denmark. The project is a research collaboration between clinicians and researchers in the field of emergency medicine and microbiology at Hospital Sønderjylland (SHS) and Odense University Hospital (OUH).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal suction | Active comparator | Procedure: Tracheal suctionUses the local standard procedure of tracheal suction to obtain secretions from the lower respiratory tract |
| Forced expiratory technique and induced sputum | Experimental | Procedure: Forced expiratory technique and induced sputumThis procedure is without suction. The patient's attempts to deliver a sputum sample after forced exhalation and coughing technique. Regardless of the result the patient then receives hypertonic saline by an inhalation mask to induce the sputum. If the patient cannot deliver a sample, tracheal suction will be performed in order to obtain a specimen for the analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted with suspected lower respiratory tract infection
- Patients > 18 years old
- One of the following symptoms: dyspnea, cough, expectoration, fever and chest tightness
Key exclusion criteria (4 listed)
- Patients transferred directly to ICU
- If the attending physician considers emergency treatment is needed
- Patients receiving prednisolone treatment of 20mg/day or more over the last 2 weeks
- Patient which consent cannot be obtained
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 |
|---|---|---|
| Forced expiratory technique and induced sputumThe intervention is based on the patient's own attempt to deliver a sputum sample after instructions of proper huff forced exhalation and coughing technique. After an attempt to deliver a sputum sample the patient will receive a 0,9% isotonic saline by an inhalation mask to induce the sputum, thereafter the patient will again make an effort to expectorate a sputum sample repeating the forced expiratory technique. | Procedure or surgery | Forced expiratory technique and induced sputum |
| Tracheal suctionTracheal suction is often used on intubated patients at the intensive care unit to collect sputum, and this method has become the standard procedure at several emergency departments. | Procedure or surgery | Tracheal suction |
Primary outcome
Quality of specimen from the lower respiratory tract
Time frame: From collection to culture results - up to 5 days
Unsuitable (bad quality) measured by microscopy - > 10 squamous epithelial cells per low power field of view (x10). Suitable (good quality) measured by microscopy - Samples with < 10 squamous epithelial cells per low power field of view
8 secondary outcomes
Patient clinical symptoms
Time frame: Patients are followed before intervention and 10 minutes after intervention
Respiratory rate
Time frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Oxygen saturation
Time frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Patient well-being and experience of procedure
Time frame: Measured twice: Baseline ( at admission) and follow up (10 minutes after intervention)
Occurrence of side effects
Time frame: Registered up to 1 hour after intervention
Short term mortality
Time frame: Registered within 7 days from hospital admission
Number of patients readmitted to hospital
Time frame: Registered within 1 month after readmission
Patient experience of sputum collection
Time frame: Measured 5 minutes after procedure
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 17 Aug 2021.
- Background: PubMed 19557211Overend TJ, Anderson CM, Brooks D, Cicutto L, Keim M, McAuslan D, Nonoyama M. Updating the evidence-base for suctioning adult patients: a systematic review. Can Respir J. 2009 May-Jun;16(3):e6-17. doi: 10.1155/2009/872921.
- Background: PubMed 31253624Skjot-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Moller JM, Ludwig M, Fuglsang-Damgaard D, Nielsen FE, Petersen DB, Jensen US, Rosenvinge FS. Carrier prevalence and risk factors for colonisation of multiresistant bacteria in Danish emergency departments: a cross-sectional survey. BMJ Open. 2019 Jun 27;9(6):e029000. doi: 10.1136/bmjopen-2019-029000.
- Background: PubMed 9403422Meehan TP, Fine MJ, Krumholz HM, Scinto JD, Galusha DH, Mockalis JT, Weber GF, Petrillo MK, Houck PM, Fine JM. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997 Dec 17;278(23):2080-4.
- Background: PubMed 31333765Karakioulaki M, Stolz D. Biomarkers and clinical scoring systems in community-acquired pneumonia. Ann Thorac Med. 2019 Jul-Sep;14(3):165-172. doi: 10.4103/atm.ATM_305_18.
- Background: PubMed 31183362Savvateeva EN, Rubina AY, Gryadunov DA. Biomarkers of Community-Acquired Pneumonia: A Key to Disease Diagnosis and Management. Biomed Res Int. 2019 Apr 30;2019:1701276. doi: 10.1155/2019/1701276. eCollection 2019.
- Background: PubMed 30949897Saukkoriipi A, Palmu AA, Jokinen J. Culture of all sputum samples irrespective of quality adds value to the diagnosis of pneumococcal community-acquired pneumonia in the elderly. Eur J Clin Microbiol Infect Dis. 2019 Jul;38(7):1249-1254. doi: 10.1007/s10096-019-03536-9. Epub 2019 Apr 4.
- Background: PubMed 18376343Miyashita N, Shimizu H, Ouchi K, Kawasaki K, Kawai Y, Obase Y, Kobashi Y, Oka M. Assessment of the usefulness of sputum Gram stain and culture for diagnosis of community-acquired pneumonia requiring hospitalization. Med Sci Monit. 2008 Apr;14(4):CR171-6.
- Background: PubMed 28702281Murdoch DR. How best to determine causative pathogens of pneumonia. Pneumonia (Nathan). 2016 Apr 12;8:1. doi: 10.1186/s41479-016-0004-z. eCollection 2016.
- Background: PubMed 29878856Herrero-Cortina B, Alcaraz V, Vilaro J, Torres A, Polverino E. Impact of Hypertonic Saline Solutions on Sputum Expectoration and Their Safety Profile in Patients with Bronchiectasis: A Randomized Crossover Trial. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):281-289. doi: 10.1089/jamp.2017.1443. Epub 2018 Jun 7.
- Derived from this study: PubMed 34600559Cartuliares MB, Skjot-Arkil H, Rosenvinge FS, Mogensen CB, Skovsted TA, Pedersen AK. Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial. Trials. 2021 Oct 2;22(1):675. doi: 10.1186/s13063-021-05639-1.
- Individual participant dataSharing planned: No
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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.
Christian Backer Mogensen, MD PhD study chair
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced expiratory technique and induced sputum and Tracheal suction in people with Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
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 17 Aug 2021. 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 Denmark. 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?
Quality of specimen from the lower respiratory tract (time frame: From collection to culture results - up to 5 days). 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 NCT04595526, which also lists 10 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 17 Aug 2021.