Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol
BackgroundSevere community-acquired pneumonia (SCAP) is the main cause of mortality in immunocompromised patients. Compared with conventional microbiological tests (CMT), metagenomic next-generation sequencing (mNGS) can quickly and simultaneously detect a wide array of bacteria, viruses, and fungi...
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Frontiers Media S.A.
2022-08-01
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmicb.2022.927842/full |
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| author | Shaohua Fan Min Si Nana Xu Meichen Yan Mingmin Pang Guangfeng Liu Jibin Gong Hao Wang |
| author_facet | Shaohua Fan Min Si Nana Xu Meichen Yan Mingmin Pang Guangfeng Liu Jibin Gong Hao Wang |
| author_sort | Shaohua Fan |
| collection | DOAJ |
| description | BackgroundSevere community-acquired pneumonia (SCAP) is the main cause of mortality in immunocompromised patients. Compared with conventional microbiological tests (CMT), metagenomic next-generation sequencing (mNGS) can quickly and simultaneously detect a wide array of bacteria, viruses, and fungi in an unbiased manner. It is increasingly used for severe respiratory infectious diseases, especially for immunocompromised patients. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes in immunocompromised patients with SCAP have not been evaluated.Methods/DesignThe MATESHIP study is a prospective, multicenter, parallel-group, open-label, randomized controlled trial from 20 ICUs in university hospitals and academic teaching hospitals across Shandong Province, China. We will enroll 342 immunocompromised patients with early onset SCAP who are admitted to an intensive care unit (ICU). Participants will be randomly allocated to an mNGS-guided treatment group or a conventional treatment group (guided by CMT), according to centrally computer-based block randomization stratified by participating centers. Participants will undergo CMT tests using appropriate lower respiratory tract (LRT) and other necessary specimens, with or without mNGS tests using LRT specimens. The primary outcomes will be: (1) The relative change in Sequential Organ Failure Assessment (SOFA) score from randomization to day 5, day 7, day 10, or the day of ICU discharge/death; and (2) the consumption of antimicrobial agents during ICU stay (expressed as defined daily doses). The secondary outcome measures will be: days from randomization to initiation of definitive antimicrobial treatment; overall antimicrobial agent use and cost; total cost of hospitalization; length of ICU stay; 28- and 90-day mortality; and clinical cure rate. This study hypothesizes that mNGS-guided treatment will decrease the degree of organ dysfunction/failure, the consumption of antimicrobial agents, and mortality, while the cure rate will be increased, and the time to initiation of appropriate therapy will be advanced.DiscussionThe MATESHIP study will evaluate for the first time whether mNGS-guided antimicrobial therapy improves the outcomes of SCAP in an immunocompromised population, and provide high-level evidence on the application of mNGS in the management of this population.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT05290454]. |
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| language | English |
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| spelling | doaj.art-5cea65b79a8c4c19933bf941a8229f8c2022-12-22T00:52:21ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2022-08-011310.3389/fmicb.2022.927842927842Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocolShaohua Fan0Min Si1Nana Xu2Meichen Yan3Mingmin Pang4Guangfeng Liu5Jibin Gong6Hao Wang7Department of Critical Care Medicine, Central Hospital Affiliated to Shandong First Medical University, Jinan, ChinaDepartment of Critical Care Medicine, Central Hospital Affiliated to Shandong First Medical University, Jinan, ChinaDepartment of Cardiac Surgery, Cardiac Surgery Care Unit, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Critical Care Medicine, Qilu Hospital of Shandong University, Jinan, ChinaBackgroundSevere community-acquired pneumonia (SCAP) is the main cause of mortality in immunocompromised patients. Compared with conventional microbiological tests (CMT), metagenomic next-generation sequencing (mNGS) can quickly and simultaneously detect a wide array of bacteria, viruses, and fungi in an unbiased manner. It is increasingly used for severe respiratory infectious diseases, especially for immunocompromised patients. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes in immunocompromised patients with SCAP have not been evaluated.Methods/DesignThe MATESHIP study is a prospective, multicenter, parallel-group, open-label, randomized controlled trial from 20 ICUs in university hospitals and academic teaching hospitals across Shandong Province, China. We will enroll 342 immunocompromised patients with early onset SCAP who are admitted to an intensive care unit (ICU). Participants will be randomly allocated to an mNGS-guided treatment group or a conventional treatment group (guided by CMT), according to centrally computer-based block randomization stratified by participating centers. Participants will undergo CMT tests using appropriate lower respiratory tract (LRT) and other necessary specimens, with or without mNGS tests using LRT specimens. The primary outcomes will be: (1) The relative change in Sequential Organ Failure Assessment (SOFA) score from randomization to day 5, day 7, day 10, or the day of ICU discharge/death; and (2) the consumption of antimicrobial agents during ICU stay (expressed as defined daily doses). The secondary outcome measures will be: days from randomization to initiation of definitive antimicrobial treatment; overall antimicrobial agent use and cost; total cost of hospitalization; length of ICU stay; 28- and 90-day mortality; and clinical cure rate. This study hypothesizes that mNGS-guided treatment will decrease the degree of organ dysfunction/failure, the consumption of antimicrobial agents, and mortality, while the cure rate will be increased, and the time to initiation of appropriate therapy will be advanced.DiscussionThe MATESHIP study will evaluate for the first time whether mNGS-guided antimicrobial therapy improves the outcomes of SCAP in an immunocompromised population, and provide high-level evidence on the application of mNGS in the management of this population.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT05290454].https://www.frontiersin.org/articles/10.3389/fmicb.2022.927842/fullmetagenomic next generation sequencingimmunosuppressionimmunocompromised patientcommunity-acquired pneumoniaantimicrobial therapy |
| spellingShingle | Shaohua Fan Min Si Nana Xu Meichen Yan Mingmin Pang Guangfeng Liu Jibin Gong Hao Wang Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol Frontiers in Microbiology metagenomic next generation sequencing immunosuppression immunocompromised patient community-acquired pneumonia antimicrobial therapy |
| title | Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol |
| title_full | Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol |
| title_fullStr | Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol |
| title_full_unstemmed | Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol |
| title_short | Metagenomic next-generation sequencing-guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community-acquired pneumonia among immunocompromised patients (MATESHIP): A study protocol |
| title_sort | metagenomic next generation sequencing guided antimicrobial treatment versus conventional antimicrobial treatment in early severe community acquired pneumonia among immunocompromised patients mateship a study protocol |
| topic | metagenomic next generation sequencing immunosuppression immunocompromised patient community-acquired pneumonia antimicrobial therapy |
| url | https://www.frontiersin.org/articles/10.3389/fmicb.2022.927842/full |
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