PneumoniaNCT05300776
M-ROSE Combined With mNGS in Severe Hospital-acquired Pneumonia
A study testing M-ROSE analysis in people with Pneumonia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- M-ROSE analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- May 2022to 31 Dec 2024
- 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
- Clinical diagnosis of severe hospital-acquired pneumonia
- Must have undergone bronchoalveolar lavage
Who cannot join
- BALF samples were not sent for mNGS examination
- Age < 18 years old
- The hospitalization days ≤ 3
- The clinical data are incomplete
- Mechanical ventilation time > 60 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yi Tao
Beijing, Beijing Municipality, 100083
Yi Tao, 17797708263
About this study
Official title: A Multi-center Prospective Clinical Study of M-ROSE Combined With mNGS to Guide the Individualized Anti-infection Treatment, Prevention and Control of Drug-resistant Bacteria in Severe Hospital-acquired Pneumonia
The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia.
Read the detailed description
Severe hospital acquired pneumonia (SHAP) is the critical risk factor leading to the death of nosocomial infection patients. Rapid identification of pathogens, guidance of individualized treatment and rational application of antibiotics can not only improve the administration of antibiotics, but also reduce the production of multi drug resistant bacteria. Metagenomic second-generation sequencing (mNGS) is an important tool to quickly identify the pathogen in ICU. However, due to the low qualified rate of lower respiratory tract specimens in patients with SHAP, easily polluted, and the difficulty to determine whether microorganisms are infectious, colonizated or polluted, the value of mNGS was limited in the etiological diagnosis of SHAP. The bedside M-ROSE system established by our research team can determine whether the lower respiratory tract specimen is qualified, whether infection exists and the pathogen of infection within half an hour. Based on the previous work, this project plans to conduct a prospective multicenter, single blind, randomized controlled study under the guidance of M-ROSE and mNGS in the individualized anti-infection strategy of SHAP, to reduce the mortality of patients with SHAP; Combined with the third-generation sequencing, the standard analysis framework for the traceability and prevention and control of drug-resistant bacteria was established to clarify the transmission route of drug-resistant bacteria, so as to provide a new solution for the prevention and control of clinical multidrug-resistant bacteria.
- Conditions
- Pneumonia
- Being tested
- M-ROSE analysis
- Keywords
- M-ROSE, mNGS, severe hospital-acquired pneumonia, treatment
- Medical subject headings
- Pneumonia, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-ROSE analysisDiagnostic test
The M-ROSE analysis process consists of 3 procudures.
- Specimen quality assessment. The BALF undergoes the process of smear, diff-quik stain, gram stain and are analyzed by experts to report the cytoloy and pathogen patterns to determine whether the sample is qualified according to the cell proportions. The qualified BALF samples are: squamous epithelial cell proportion<1%, columnar epithelial cell proportion <5% .
- Distinguish infection and colonization. According to the cytoloy pattern, the proportion of neutrophils > 50% often strongly suggests pulmonary bacterial infection; Neutrophil phagocytosis proportion> 5% indicates infection, and phagocytosis of bacteria is the pathogen. Besides, fungal and hyphae can be found under the microscope.
- Preliminary identification of infectious pathogens. Identify the infected bacteria and fungi, and the results are gram-positive cocci, gram-positive bacilli, gram-negative cocci, gram-negative bacilli, yeasts and molds.
| Study group | Role | What they receive |
|---|---|---|
| M-ROSE combined with mNGS group | Experimental | The bronchoalveolar lavage fluid (BALF) of patients undergoes M-ROSE analysis and decide whether the samples are qualified, whether they indicate bacterial infection and identify pathogens, and the qualified samples are sent for mNGS analysis. The individualized anti-infection treatment is comprehensively guided according to the results of M-ROSE, mNGS and clinical examinations. Receives: Diagnostic Test: M-ROSE analysis |
| mNGS group | No intervention | BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Alive or Dead.
Measured: During the intervention.
Secondary outcomes (6)
Blood leukocyte ratio tread
The changing of blood leukocyte ratio
Measured: During the intervention.
28 day outcome
Live or dead.
Measured: 28 days after admission
Blood neutriphil ratio tread
The changing of blood neutriphil ratio tread
Measured: During the intervention.
Blood interleukin 6 tread
The changing of blood interleukin 6 tread
Measured: During the intervention.
Blood C-reactive protein
The changing of blood C-reactive protein
Measured: During the intervention.
Blood procalcitonin tread
The changing of blood procalcitonin tread
Measured: During the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study startMay 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
- Investigators
- Lixin Xie, Ph.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300776
- Sponsor's protocol ID
- shoufa2022-1-5091
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Wang K, Xie F, Han Z, Liu Y, Pan L, Zhu G, Cao Z, Yan P, Xiao L, Duan Z, Hu Y, Xiao K, Chen X, Fu H, Shi Y, Song Y, Han X, Xie W, Xie L. Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia. Trials. 2023 Aug 23;24(1):552. doi: 10.1186/s13063-023-07570-z.
PubMed 37612723
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Clinical Study of M-ROSE Combined With mNGS to Guide the Individualized Anti-infection Treatment, Prevention and Control of Drug-resistant Bacteria in Severe Hospital-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05300776
- Acronym / sponsor ID
- shoufa2022-1-5091
- Conditions
- Pneumonia
- Keywords
- M-ROSE, mNGS, severe hospital-acquired pneumonia, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University
- Study start
- May 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2022 (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.
The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia.
Detailed description
Severe hospital acquired pneumonia (SHAP) is the critical risk factor leading to the death of nosocomial infection patients. Rapid identification of pathogens, guidance of individualized treatment and rational application of antibiotics can not only improve the administration of antibiotics, but also reduce the production of multi drug resistant bacteria. Metagenomic second-generation sequencing (mNGS) is an important tool to quickly identify the pathogen in ICU. However, due to the low qualified rate of lower respiratory tract specimens in patients with SHAP, easily polluted, and the difficulty to determine whether microorganisms are infectious, colonizated or polluted, the value of mNGS was limited in the etiological diagnosis of SHAP. The bedside M-ROSE system established by our research team can determine whether the lower respiratory tract specimen is qualified, whether infection exists and the pathogen of infection within half an hour. Based on the previous work, this project plans to conduct a prospective multicenter, single blind, randomized controlled study under the guidance of M-ROSE and mNGS in the individualized anti-infection strategy of SHAP, to reduce the mortality of patients with SHAP; Combined with the third-generation sequencing, the standard analysis framework for the traceability and prevention and control of drug-resistant bacteria was established to clarify the transmission route of drug-resistant bacteria, so as to provide a new solution for the prevention and control of clinical multidrug-resistant bacteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-ROSE combined with mNGS group | Experimental | Diagnostic Test: M-ROSE analysisThe bronchoalveolar lavage fluid (BALF) of patients undergoes M-ROSE analysis and decide whether the samples are qualified, whether they indicate bacterial infection and identify pathogens, and the qualified samples are sent for mNGS analysis. The individualized anti-infection treatment is comprehensively guided according to the results of M-ROSE, mNGS and clinical examinations. |
| mNGS group | No intervention | –BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of severe hospital-acquired pneumonia
- Must have undergone bronchoalveolar lavage
Key exclusion criteria (5 listed)
- BALF samples were not sent for mNGS examination
- Age < 18 years old
- The hospitalization days ≤ 3
- The clinical data are incomplete
- Mechanical ventilation time > 60 days
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 |
|---|---|---|
| M-ROSE analysisThe M-ROSE analysis process consists of 3 procudures. 1. Specimen quality assessment. The BALF undergoes the process of smear, diff-quik stain, gram stain and are analyzed by experts to report the cytoloy and pathogen patterns to determine whether the sample is qualified according to the cell proportions. The qualified BALF samples are: squamous epithelial cell proportion<1%, columnar epithelial cell proportion <5% . 2. Distinguish infection and colonization. According to the cytoloy pattern, the proportion of neutrophils > 50% often strongly suggests pulmonary bacterial infection; Neutrophil phagocytosis proportion> 5% indicates infection, and phagocytosis of bacteria is the pathogen. Besides, fungal and hyphae can be found under the microscope. 3. Preliminary identification of infectious pathogens. Identify the infected bacteria and fungi, and the results are gram-positive cocci, gram-positive bacilli, gram-negative cocci, gram-negative bacilli, yeasts and molds. | Diagnostic test | M-ROSE combined with mNGS group |
Primary outcome
mortality
Time frame: During the intervention.
Alive or Dead.
6 secondary outcomes
Blood leukocyte ratio tread
Time frame: During the intervention.
28 day outcome
Time frame: 28 days after admission
Blood neutriphil ratio tread
Time frame: During the intervention.
Blood interleukin 6 tread
Time frame: During the intervention.
Blood C-reactive protein
Time frame: During the intervention.
Blood procalcitonin tread
Time frame: During the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 37612723Wang X, Wang K, Xie F, Han Z, Liu Y, Pan L, Zhu G, Cao Z, Yan P, Xiao L, Duan Z, Hu Y, Xiao K, Chen X, Fu H, Shi Y, Song Y, Han X, Xie W, Xie L. Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia. Trials. 2023 Aug 23;24(1):552. doi: 10.1186/s13063-023-07570-z.
- 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.
Lixin Xie, Ph.D principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-ROSE analysis in people with Pneumonia, run by Chinese PLA General Hospital at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Tao, Ph.D (+8617797708263, taoyimmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: During the intervention.). 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 NCT05300776, 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 26 Apr 2022.