Cystic FibrosisANA-MUCONCT04879381
Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients: Descriptive and Non-interventional Study
An observational study of Cystic Fibrosis, run by University Hospital, Brest at 2 sites in France.
Trial summary
Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sputum samples
- How many people
- 101 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Mar 2018to 5 Oct 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cystic Fibrosis patients
Who may be able to join
- Patients with a confirmed diagnosis of Cystic Fibrosis regardless of CFTR genotype
- Persons affiliated to the social security system
- Minor or major patients able to expectorate spontaneously or after induction
- Consent signed by the patient or the holder of parental authority for the children
Who cannot join
- Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
- Persons non affiliated to a social security system or not entitled
- Pulmonary transplant patients
- Refusal to participate to the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients Followed by the Perharidy Cystic Fibrosis Resource and Skills Centre, Roscoff: Descriptive and Non-interventional Study
Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization.
The aim of this project is to describe the bacterial anaerobic population in the respiratory microbiota of a CF cohort. At the end of this study, an inventory of the anaerobic microbiota in CF respiratory samples will be establish in relation to the patients' pulmonary function and P. aeruginosa colonization status in order to speculate about the pulmonary anaerobes roles, still unknown.
The innovative aspect of the ANA-MUCO study is the use of a specific sample kit designed for the study which allows preserving anaerobic bacteria in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Extended-culture and molecular approaches will be performed to identify and describe the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.
Read the detailed description
Cystic Fibrosis (CF) is a lethal genetic disease whose prognostic depends on the patients' respiratory impairment. Indeed, the airways microbial chronic colonization, particularly to Pseudomonas aeruginosa, leads to infectious exacerbations and to noteworthy respiratory function impairment and represents the main cause of morbidity and mortality. Nowadays, antibiotherapy is the main therapeutic solution to thwart bacterial development and to slow respiratory function degradation. However, during the disease progression, this therapeutical approach is limited by the bacteria accommodation and antibiotic resistance development.
Thanks to the development of high-throughput sequencing methods, the respiratory microbiota of CF patients has been mainly described and points the way to new therapeutic approaches. It has been establish that, i) from an early age, the respiratory microbiota of CF children is modified in comparison with the healthy children one, ii) bacterial diversity decrease progressively throughout the disease evolution, iii) anaerobes represent an important part of the healthy and CF respiratory microbiota. Thus pulmonary microbiota composition could be a better disease progression indicator than the only detection of P. aeruginosa in CF respiratory samples. Furthermore, the respiratory microbiota could influence the pathogenesis through direct interactions between micro-organism/micro-organism or micro-organism/host. Recently, thanks to the respiratory microbiota characterisation of a CF patients' cohort (MUCOBIOME study, 2012-2015), the potential role of anaerobes (and particularly species belonging to the genus Porphyromonas) in the first P. aeruginosa colonization has been highlighted. Indeed, the respiratory microbiota study of 34 CF patients has revealed that if patients are deprived or lowly colonized by Porphyromonas spp., the relative risk of P. aeruginosa colonization is 3.7 fold higher. Conversely, the relative abundance's increase of Porphyromonas spp. in CF patients receiving Ivacaftor treatment is correlated with the respiratory function improvement. Thus, in addition to be used as biomarker, the investigators speculate on the fact that some strict anaerobic species, such as Porphyromonas spp., could act as CF pathogens (like P. aeruginosa) competitors and limit their setting up in the airways.
The investigators see here the necessity of complementary studies in order to better characterise anaerobic bacteria in the airways. The aim of the ANA-MUCO study is to identify and describe anaerobic bacteria in sputum of a CF patients' cohort, to characterise the antibiotic resistance profiles of the anaerobic species isolated, to study the anaerobes repartition within the CF population and to evaluate the interactions between anaerobes and CF pathogens (P. aeruginosa, S. aureus, H. influenzae, …). In order to be the most exhaustive as possible in the anaerobes description, the innovative aspect of this study is the conception and the use of a specific sample kit which preserves anaerobic conditions in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Then, extended-culture and molecular approaches will be performed to identify the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.
- Conditions
- Cystic Fibrosis
- Being tested
- Sputum samples
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum samplesOther
During consultation, one expectoration will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis patients | Sputum samples Receives: Other: Sputum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of anaerobic bacteria in sputum by culture and molecular approaches
The presence of anaerobic bacteria will be evaluated by culture and molecular approaches with regard of the number of sputum collected.
Measured: Inclusion ( Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start29 Mar 2018
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Responsible party
- Sponsor
- Investigators
- Geneviève HERY-ARNAUD, Professor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879381
- Sponsor's protocol ID
- ANA-MUCO ( 29BRC18.0045)
- Acronym
- ANA-MUCO
- Status last verified
- Jan 2021
- First submitted
- 11 Feb 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Publications
Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, Grimwood K. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. J Pediatr. 2001 May;138(5):699-704. doi: 10.1067/mpd.2001.112897.
PubMed 11343046Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.
PubMed 20585638Renwick J, McNally P, John B, DeSantis T, Linnane B, Murphy P; SHIELD CF. The microbial community of the cystic fibrosis airway is disrupted in early life. PLoS One. 2014 Dec 19;9(12):e109798. doi: 10.1371/journal.pone.0109798. eCollection 2014.
PubMed 25526264Klepac-Ceraj V, Lemon KP, Martin TR, Allgaier M, Kembel SW, Knapp AA, Lory S, Brodie EL, Lynch SV, Bohannan BJ, Green JL, Maurer BA, Kolter R. Relationship between cystic fibrosis respiratory tract bacterial communities and age, genotype, antibiotics and Pseudomonas aeruginosa. Environ Microbiol. 2010 May;12(5):1293-303. doi: 10.1111/j.1462-2920.2010.02173.x. Epub 2010 Feb 23.
PubMed 20192960Sibley CD, Surette MG. The polymicrobial nature of airway infections in cystic fibrosis: Cangene Gold Medal Lecture. Can J Microbiol. 2011 Feb;57(2):69-77. doi: 10.1139/w10-105.
PubMed 21326348Bernarde C, Keravec M, Mounier J, Gouriou S, Rault G, Ferec C, Barbier G, Hery-Arnaud G. Impact of the CFTR-potentiator ivacaftor on airway microbiota in cystic fibrosis patients carrying a G551D mutation. PLoS One. 2015 Apr 8;10(4):e0124124. doi: 10.1371/journal.pone.0124124. eCollection 2015.
PubMed 25853698Guilloux CA, Lamoureux C, Hery-Arnaud G. [Anaerobic bacteria, the unknown members of the lung microbiota]. Med Sci (Paris). 2018 Mar;34(3):253-260. doi: 10.1051/medsci/20183403014. Epub 2018 Mar 16. French.
PubMed 29547112Tunney MM, Field TR, Moriarty TF, Patrick S, Doering G, Muhlebach MS, Wolfgang MC, Boucher R, Gilpin DF, McDowell A, Elborn JS. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med. 2008 May 1;177(9):995-1001. doi: 10.1164/rccm.200708-1151OC. Epub 2008 Feb 8.
PubMed 18263800Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010.
PubMed 24856775Hery-Arnaud G, Nowak E, Caillon J, David V, Dirou A, Revert K, Munck MR, Frachon I, Haloun A, Horeau-Langlard D, Le Bihan J, Danner-Boucher I, Ramel S, Pelletier MP, Rosec S, Gouriou S, Poulhazan E, Payan C, Ferec C, Rault G, Le Gal G, Le Berre R. Evaluation of quantitative PCR for early diagnosis of Pseudomonas aeruginosa infection in cystic fibrosis: a prospective cohort study. Clin Microbiol Infect. 2017 Mar;23(3):203-207. doi: 10.1016/j.cmi.2016.11.016. Epub 2016 Nov 27.
PubMed 27903460Lamoureux C, Guilloux CA, Beauruelle C, Jolivet-Gougeon A, Hery-Arnaud G. Anaerobes in cystic fibrosis patients' airways. Crit Rev Microbiol. 2019 Feb;45(1):103-117. doi: 10.1080/1040841X.2018.1549019. Epub 2019 Jan 21.
PubMed 30663924Société Française de Microbiologie. REMIC, Référentiel en Microbiologie Médicale, 2 volumes. SFM, 2015. 856 p. ISBN 9782878050325.
CA-SFM EUCAST [En ligne]. Société Française de Microbiologie, 2013 [consulté le 11 janvier 2018]. Available on: http://www.sfmmicrobiologie.org/UserFiles/files/casfm/CASFM2013vjuin.pdf
Héry-Arnaud et al., 2017, European patent EP17306297 Methods for predicting the risk of developping pulmonary colonization/infection by Pseudomonas aeruginosa.
Keravec M, Mounier J, Guilloux CA, Fangous MS, Mondot S, Vallet S, Gouriou S, Le Berre R, Rault G, Ferec C, Barbier G, Lepage P, Hery-Arnaud G. Porphyromonas, a potential predictive biomarker of Pseudomonas aeruginosa pulmonary infection in cystic fibrosis. BMJ Open Respir Res. 2019 Mar 12;6(1):e000374. doi: 10.1136/bmjresp-2018-000374. eCollection 2019.
PubMed 30956802
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients Followed by the Perharidy Cystic Fibrosis Resource and Skills Centre, Roscoff: Descriptive and Non-interventional Study
- ClinicalTrials.gov ID
- NCT04879381
- Acronym / sponsor ID
- ANA-MUCO / ANA-MUCO ( 29BRC18.0045)
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 10 May 2021 (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.
Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization.
The aim of this project is to describe the bacterial anaerobic population in the respiratory microbiota of a CF cohort. At the end of this study, an inventory of the anaerobic microbiota in CF respiratory samples will be establish in relation to the patients' pulmonary function and P. aeruginosa colonization status in order to speculate about the pulmonary anaerobes roles, still unknown.
The innovative aspect of the ANA-MUCO study is the use of a specific sample kit designed for the study which allows preserving anaerobic bacteria in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Extended-culture and molecular approaches will be performed to identify and describe the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.
Detailed description
Cystic Fibrosis (CF) is a lethal genetic disease whose prognostic depends on the patients' respiratory impairment. Indeed, the airways microbial chronic colonization, particularly to Pseudomonas aeruginosa, leads to infectious exacerbations and to noteworthy respiratory function impairment and represents the main cause of morbidity and mortality. Nowadays, antibiotherapy is the main therapeutic solution to thwart bacterial development and to slow respiratory function degradation. However, during the disease progression, this therapeutical approach is limited by the bacteria accommodation and antibiotic resistance development.
Thanks to the development of high-throughput sequencing methods, the respiratory microbiota of CF patients has been mainly described and points the way to new therapeutic approaches. It has been establish that, i) from an early age, the respiratory microbiota of CF children is modified in comparison with the healthy children one, ii) bacterial diversity decrease progressively throughout the disease evolution, iii) anaerobes represent an important part of the healthy and CF respiratory microbiota. Thus pulmonary microbiota composition could be a better disease progression indicator than the only detection of P. aeruginosa in CF respiratory samples. Furthermore, the respiratory microbiota could influence the pathogenesis through direct interactions between micro-organism/micro-organism or micro-organism/host. Recently, thanks to the respiratory microbiota characterisation of a CF patients' cohort (MUCOBIOME study, 2012-2015), the potential role of anaerobes (and particularly species belonging to the genus Porphyromonas) in the first P. aeruginosa colonization has been highlighted. Indeed, the respiratory microbiota study of 34 CF patients has revealed that if patients are deprived or lowly colonized by Porphyromonas spp., the relative risk of P. aeruginosa colonization is 3.7 fold higher. Conversely, the relative abundance's increase of Porphyromonas spp. in CF patients receiving Ivacaftor treatment is correlated with the respiratory function improvement. Thus, in addition to be used as biomarker, the investigators speculate on the fact that some strict anaerobic species, such as Porphyromonas spp., could act as CF pathogens (like P. aeruginosa) competitors and limit their setting up in the airways.
The investigators see here the necessity of complementary studies in order to better characterise anaerobic bacteria in the airways. The aim of the ANA-MUCO study is to identify and describe anaerobic bacteria in sputum of a CF patients' cohort, to characterise the antibiotic resistance profiles of the anaerobic species isolated, to study the anaerobes repartition within the CF population and to evaluate the interactions between anaerobes and CF pathogens (P. aeruginosa, S. aureus, H. influenzae, …). In order to be the most exhaustive as possible in the anaerobes description, the innovative aspect of this study is the conception and the use of a specific sample kit which preserves anaerobic conditions in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Then, extended-culture and molecular approaches will be performed to identify the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis patients | – | Other: Sputum samplesSputum samples |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic Fibrosis patients
Key inclusion criteria (4 listed)
- Patients with a confirmed diagnosis of Cystic Fibrosis regardless of CFTR genotype
- Persons affiliated to the social security system
- Minor or major patients able to expectorate spontaneously or after induction
- Consent signed by the patient or the holder of parental authority for the children
Key exclusion criteria (4 listed)
- Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
- Persons non affiliated to a social security system or not entitled
- Pulmonary transplant patients
- Refusal to participate to the study
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 |
|---|---|---|
| Sputum samplesDuring consultation, one expectoration will be performed. | Other | Cystic Fibrosis patients |
Primary outcome
Presence of anaerobic bacteria in sputum by culture and molecular approaches
Time frame: Inclusion ( Day 0)
The presence of anaerobic bacteria will be evaluated by culture and molecular approaches with regard of the number of sputum collected.
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 30 Jun 2021.
- Background: PubMed 11343046Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, Grimwood K. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. J Pediatr. 2001 May;138(5):699-704. doi: 10.1067/mpd.2001.112897.
- Background: PubMed 20585638Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.
- Background: PubMed 25526264Renwick J, McNally P, John B, DeSantis T, Linnane B, Murphy P; SHIELD CF. The microbial community of the cystic fibrosis airway is disrupted in early life. PLoS One. 2014 Dec 19;9(12):e109798. doi: 10.1371/journal.pone.0109798. eCollection 2014.
- Background: PubMed 20192960Klepac-Ceraj V, Lemon KP, Martin TR, Allgaier M, Kembel SW, Knapp AA, Lory S, Brodie EL, Lynch SV, Bohannan BJ, Green JL, Maurer BA, Kolter R. Relationship between cystic fibrosis respiratory tract bacterial communities and age, genotype, antibiotics and Pseudomonas aeruginosa. Environ Microbiol. 2010 May;12(5):1293-303. doi: 10.1111/j.1462-2920.2010.02173.x. Epub 2010 Feb 23.
- Background: PubMed 21326348Sibley CD, Surette MG. The polymicrobial nature of airway infections in cystic fibrosis: Cangene Gold Medal Lecture. Can J Microbiol. 2011 Feb;57(2):69-77. doi: 10.1139/w10-105.
- Background: PubMed 25853698Bernarde C, Keravec M, Mounier J, Gouriou S, Rault G, Ferec C, Barbier G, Hery-Arnaud G. Impact of the CFTR-potentiator ivacaftor on airway microbiota in cystic fibrosis patients carrying a G551D mutation. PLoS One. 2015 Apr 8;10(4):e0124124. doi: 10.1371/journal.pone.0124124. eCollection 2015.
- Background: PubMed 29547112Guilloux CA, Lamoureux C, Hery-Arnaud G. [Anaerobic bacteria, the unknown members of the lung microbiota]. Med Sci (Paris). 2018 Mar;34(3):253-260. doi: 10.1051/medsci/20183403014. Epub 2018 Mar 16. French.
- Background: PubMed 18263800Tunney MM, Field TR, Moriarty TF, Patrick S, Doering G, Muhlebach MS, Wolfgang MC, Boucher R, Gilpin DF, McDowell A, Elborn JS. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med. 2008 May 1;177(9):995-1001. doi: 10.1164/rccm.200708-1151OC. Epub 2008 Feb 8.
- Background: PubMed 24856775Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010.
- Background: PubMed 27903460Hery-Arnaud G, Nowak E, Caillon J, David V, Dirou A, Revert K, Munck MR, Frachon I, Haloun A, Horeau-Langlard D, Le Bihan J, Danner-Boucher I, Ramel S, Pelletier MP, Rosec S, Gouriou S, Poulhazan E, Payan C, Ferec C, Rault G, Le Gal G, Le Berre R. Evaluation of quantitative PCR for early diagnosis of Pseudomonas aeruginosa infection in cystic fibrosis: a prospective cohort study. Clin Microbiol Infect. 2017 Mar;23(3):203-207. doi: 10.1016/j.cmi.2016.11.016. Epub 2016 Nov 27.
- Background: PubMed 30663924Lamoureux C, Guilloux CA, Beauruelle C, Jolivet-Gougeon A, Hery-Arnaud G. Anaerobes in cystic fibrosis patients' airways. Crit Rev Microbiol. 2019 Feb;45(1):103-117. doi: 10.1080/1040841X.2018.1549019. Epub 2019 Jan 21.
- BackgroundSociété Française de Microbiologie. REMIC, Référentiel en Microbiologie Médicale, 2 volumes. SFM, 2015. 856 p. ISBN 9782878050325.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
Geneviève HERY-ARNAUD, Professor principal investigator
University Hospital, Brest
2 sites 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 University Hospital, Brest at 2 sites in France.
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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Presence of anaerobic bacteria in sputum by culture and molecular approaches (time frame: Inclusion ( Day 0)). 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 NCT04879381, which also lists 15 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 30 Jun 2021.