An interventional study of results of SSBD are used to guide antibiotics adjustment in Severe Pneumonia, sponsored by Chinese Medical Association. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Chinese Medical Association · Not applicable, Interventional, and Diagnostic
This study is a multicenter randomized controlled trial. The purpose of this study is to assess the efficacy of Species-specific Bacterial Dector（SSBD）for fast pathogen diagnosis and treatment in patients with severe pneumonia. Several adult ICU units from the hospitals in Jiangsu province participate the study and the hosted unit is the Department of Critical Care Medicine, Affiliated Drum Tower Hospital of Nanjing University Medical College. All patients who met the inclusion criteria are enrolled and randomly assigned either to the experiment group or to the control group, and received empiral antibiotics initially. In the experiment group, secretions from low respiratory tract are detected by SSBD and conventional culture tests simultaneously on day1,day3 and day7 after enrollment, while in the control group conventional culture tests are carried out on the same days. In the experiment group, antibiotics adjustments are made by two experienced doctors immediately when SSBD results are available, and other treatments are equivalent to those in the control group as routinely. Some clinical parameters and outcomes are recorded.
Sepsis is associated with high morbidity and mortality . Adequate antibiotic therapy in time could decrease mortality and reduce the length of stay in ICU for patients with sepsis or septic shock . As reported in the previous study, the mortality rate of patients increased approximately 7.6% for every hour delayed. Therefore, rapid diagnosis of pathogenic microorganisms is crucial for shortening the time of empirical antibiotic therapy and improving the prognosis of patients with sepsis.
Conventional culture test (CCT) is the most commonly used and golden standard identification method of pathogenic microorganisms in most countries. However, it showed two critical limitations: long time-consuming (2-5 days) and low sensitivity (30-50%), which limited the application of this method in the ICU . To overcome this bottleneck, several new tools were developed and showed significant improvement in time consumption and accuracy. Recently, next-generation sequencing (NGS) technology was applied to acquire the entire information of microorganisms and demonstrated great ability in diagnosing rare pathogens. However, the whole process still needs at least 2 days for the full diagnostic report with high cost. On the other hand, NGS provided too much information about microorganisms but only semi-quantification of pathogens, which was hard for most clinical doctors to extract the most important information to determine antibiotic usage. Other new emerging detection techniques designed by BioFire and Curetis are much superior in detection time than these above. However, its original principle was based on nucleotide diversity of conserved genes among species, which could not satisfy the application in the ICU due to potential false-positive results. Therefore, a unique diagnosis tool aimed at faster and more accurate pathogen identification in the ICU was still a great challenge.
Species-specific gene sequences for bacteria are found creatively. Based on these sequences, species-specific Bacterial Dector（SSBD) are designed. By SSBD, accurate and rapid detection of the most common pathogenic bacteria of sepsis could be carried out bedside conveniently in the ICU in 2\~3 hours. A multiple-center randomized controlled trial will be conducted in ICU pneumonia patients to evaluate clinical benefits from SSBD.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 256 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Chinese Medical Association is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
antibiotics adjustments are made by two experienced doctors immediately when SSBD results are available, and other treatments are equivalent to those in the control group as routinely
Diagnostic Test: results of SSBD are used to guide antibiotics adjustment
As routinely, antibiotics adjustmens are guided on the results of conventional culture tests and other clinical parameters by two experienced doctors.
secretions from low resipratory will be obtained on day1,day 3 and day7 after enrollment and detected by SSBD at bedside at once. Antibiotics will be adjusted on the results by experienced doctors.
Improved Acute Physiology and Chronic Health Evaluation score II score
Acute Physiology and Chronic Health Evaluation score II score will be assessed and compared on day1, day3, day7, day10 and day14
Time frame: up to 14 days
the therapeutic turnaround time (TTAT)
the time from collecting the specimen for the investigation to initiating appropriate treatment on the results available on test1, test2 ,test3 day.
Time frame: on day1, day3,day7
coverage of appropriate antibiotics
numbers of patients with appropriate antibiotics
Time frame: on day1, day3,day7
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Jun 2025, 7 months later.
Of 258 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 7 months is below that.
Counting every sponsor, half of 265 studies reached it within 21 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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