Prospective Study of Multi-centers Exploring the Difference of Clinical Impact by Using Respiratory Pathogen ID/AMR Panel (RPIP) Versus Untarget Metagenomic Next-generation Sequencing (mNGS) and Multiplex PCR in Pathogen Identification of Pneumonia Patients in Intensive Care Unit

NCT07626073 | Enrolling By Invitation

• 1 other identifier: CMUH112-REC1-087
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia, pathogen involved to lower respiratory tract and leading lung parenchyma infection, is one of the three most common infectious diseases in the world. Rapidly and correctly diagnosis and prescription could reduce the complication, length of hospitalization and mortality rate, especially for the critically patients in intensive care unit. Among the current microbiological diagnostic methods, the current traditional culture combined with biochemical identification method is easily affected by the drug using and different species, and time consuming. Although other diagnostic methods like MALDI-TOF MS、multiplex PCR also common and available in clinically, but owing some limitations like lower resolution, inability to afford the drug sensitivity of pathogen. Whole genome sequencing is one of the potential developing tools in pathogen identification, especially the next-general sequencing. The advantage of Metagenomic NGS (mNGS) in the application of clinical microbial detection is that it can identify various species and provide drug resistance gene information at the same time. However, background DNA from non-pathogens can highly affect the sensitivity of next-generation sequencing (untargeted mNGS). The Respiratory Pathogen ID/AMR Panel (RPIP) is a targeted mNGS developed by Illumina, which can provide the detection results of pathogen type and resistant gene. This study is a prospective multi-centers study to explore using the new diagnostic tool of " RPIP " and the different detection methods of next-generation sequencing and multiplex PCR in patients with pneumonia in ICU. Further compare the difference of pathogen identification and clinical impact by different diagnostic methods.

Conditions

Respiratory Pathogens

Outcome Measures

Primary Outcomes (1)

• The expected outcomes to validate the effectiveness of RPIP application in the treatment of pneumonia patients in intensive care units, and to evaluate the value of this method in pathogen identification and clinical treatment decision-making.

  The turnaround time between RPIP results and the final report of the standard test is compared to evaluate the time saved by using RPIP. The proportion of clinical treatment strategy adjustments prompted by RPIP results is analyzed, as well as the proportion of inappropriate empirical treatments. It also analyzes whether adjustments in treatment strategies have an impact on mortality.

  After obtaining informed consent, samples will be collected from ICU patients with severe pneumonia at that hospitalization.

Secondary Outcomes (1)

• Generalization medical information

  Collect data admission period, 28-day and 90-day mortality.

Study Arms (1)

ICU pneumonia patient

Standard-of-care test: Bacterial and fungal testing: BAL and ETA or sputum specimens are subjected to Gram staining, and aerobic, anaerobic, and fungal cultures are performed. Mycobacterium culture is performed, and PCR is used to detect mycobacterial DNA. Other tests included atypical pathogen, aspergillus and virus survey. FilmArray PP can detect 15 bacterial species, 3 atypical bacteria, 8 viruses, and detect 7 antimicrobial resistance genes. Respiratory Pathogen ID/AMR enrichment (RPIP): According to the manufacturer's instructions, the workflow includes nucleic acid extraction, cDNA synthesis, sequencing library construction, target amplification, library quality testing, sequencing, and analysis. Untargeted mNGS: The sample is outsourced to a biotechnology company for mNGS analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU pneumonia patients

You may qualify if:

• Patients admitted to the intensive care unit who meet the diagnosis of pneumonia

You may not qualify if:

• Under 18 years old

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Biomedical Technology R&D Center

Taichung, 40447, Taiwan

Location

Related Publications (37)

• Rodrigues CMC, Groves H. Community-Acquired Pneumonia in Children: the Challenges of Microbiological Diagnosis. J Clin Microbiol. 2018 Feb 22;56(3):e01318-17. doi: 10.1128/JCM.01318-17. Print 2018 Mar.

  PMID: 29237789 BACKGROUND

• DiBardino DM, Wunderink RG. Aspiration pneumonia: a review of modern trends. J Crit Care. 2015 Feb;30(1):40-8. doi: 10.1016/j.jcrc.2014.07.011. Epub 2014 Jul 22.

  PMID: 25129577 BACKGROUND

• Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociacion Latinoamericana del Torax (ALAT). Eur Respir J. 2017 Sep 10;50(3):1700582. doi: 10.1183/13993003.00582-2017. Print 2017 Sep.

  PMID: 28890434 BACKGROUND

• Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med. 2004 Mar 22;164(6):637-44. doi: 10.1001/archinte.164.6.637.

  PMID: 15037492 BACKGROUND

• Esperatti M, Ferrer M, Theessen A, Liapikou A, Valencia M, Saucedo LM, Zavala E, Welte T, Torres A. Nosocomial pneumonia in the intensive care unit acquired by mechanically ventilated versus nonventilated patients. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1533-9. doi: 10.1164/rccm.201001-0094OC. Epub 2010 Aug 6.

  PMID: 20693381 BACKGROUND

• Battleman DS, Callahan M, Thaler HT. Rapid antibiotic delivery and appropriate antibiotic selection reduce length of hospital stay of patients with community-acquired pneumonia: link between quality of care and resource utilization. Arch Intern Med. 2002 Mar 25;162(6):682-8. doi: 10.1001/archinte.162.6.682.

  PMID: 11911722 BACKGROUND

• Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27. doi: 10.1056/NEJMoa1500245. Epub 2015 Jul 14.

  PMID: 26172429 BACKGROUND

• Davidson KR, Ha DM, Schwarz MI, Chan ED. Bronchoalveolar lavage as a diagnostic procedure: a review of known cellular and molecular findings in various lung diseases. J Thorac Dis. 2020 Sep;12(9):4991-5019. doi: 10.21037/jtd-20-651.

  PMID: 33145073 BACKGROUND

• Hertz MI, Woodward ME, Gross CR, Swart M, Marcy TW, Bitterman PB. Safety of bronchoalveolar lavage in the critically ill, mechanically ventilated patient. Crit Care Med. 1991 Dec;19(12):1526-32. doi: 10.1097/00003246-199112000-00015.

  PMID: 1959373 BACKGROUND

• Chen Q, Yi J, Liu Y, Yang C, Sun Y, Du J, Liu Y, Gu D, Liu H, Xu Y, Chen Y. Clinical diagnostic value of targeted next-generation sequencing for infectious diseases (Review). Mol Med Rep. 2024 Sep;30(3):153. doi: 10.3892/mmr.2024.13277. Epub 2024 Jul 4.

  PMID: 38963022 BACKGROUND

• Wilson MR, Naccache SN, Samayoa E, Biagtan M, Bashir H, Yu G, Salamat SM, Somasekar S, Federman S, Miller S, Sokolic R, Garabedian E, Candotti F, Buckley RH, Reed KD, Meyer TL, Seroogy CM, Galloway R, Henderson SL, Gern JE, DeRisi JL, Chiu CY. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. N Engl J Med. 2014 Jun 19;370(25):2408-17. doi: 10.1056/NEJMoa1401268. Epub 2014 Jun 4.

  PMID: 24896819 BACKGROUND

• Lee SH, Ruan SY, Pan SC, Lee TF, Chien JY, Hsueh PR. Performance of a multiplex PCR pneumonia panel for the identification of respiratory pathogens and the main determinants of resistance from the lower respiratory tract specimens of adult patients in intensive care units. J Microbiol Immunol Infect. 2019 Dec;52(6):920-928. doi: 10.1016/j.jmii.2019.10.009. Epub 2019 Nov 23.

  PMID: 31806539 BACKGROUND

• Bentley DR, Balasubramanian S, Swerdlow HP, Smith GP, Milton J, Brown CG, Hall KP, Evers DJ, Barnes CL, Bignell HR, Boutell JM, Bryant J, Carter RJ, Keira Cheetham R, Cox AJ, Ellis DJ, Flatbush MR, Gormley NA, Humphray SJ, Irving LJ, Karbelashvili MS, Kirk SM, Li H, Liu X, Maisinger KS, Murray LJ, Obradovic B, Ost T, Parkinson ML, Pratt MR, Rasolonjatovo IM, Reed MT, Rigatti R, Rodighiero C, Ross MT, Sabot A, Sankar SV, Scally A, Schroth GP, Smith ME, Smith VP, Spiridou A, Torrance PE, Tzonev SS, Vermaas EH, Walter K, Wu X, Zhang L, Alam MD, Anastasi C, Aniebo IC, Bailey DM, Bancarz IR, Banerjee S, Barbour SG, Baybayan PA, Benoit VA, Benson KF, Bevis C, Black PJ, Boodhun A, Brennan JS, Bridgham JA, Brown RC, Brown AA, Buermann DH, Bundu AA, Burrows JC, Carter NP, Castillo N, Chiara E Catenazzi M, Chang S, Neil Cooley R, Crake NR, Dada OO, Diakoumakos KD, Dominguez-Fernandez B, Earnshaw DJ, Egbujor UC, Elmore DW, Etchin SS, Ewan MR, Fedurco M, Fraser LJ, Fuentes Fajardo KV, Scott Furey W, George D, Gietzen KJ, Goddard CP, Golda GS, Granieri PA, Green DE, Gustafson DL, Hansen NF, Harnish K, Haudenschild CD, Heyer NI, Hims MM, Ho JT, Horgan AM, Hoschler K, Hurwitz S, Ivanov DV, Johnson MQ, James T, Huw Jones TA, Kang GD, Kerelska TH, Kersey AD, Khrebtukova I, Kindwall AP, Kingsbury Z, Kokko-Gonzales PI, Kumar A, Laurent MA, Lawley CT, Lee SE, Lee X, Liao AK, Loch JA, Lok M, Luo S, Mammen RM, Martin JW, McCauley PG, McNitt P, Mehta P, Moon KW, Mullens JW, Newington T, Ning Z, Ling Ng B, Novo SM, O'Neill MJ, Osborne MA, Osnowski A, Ostadan O, Paraschos LL, Pickering L, Pike AC, Pike AC, Chris Pinkard D, Pliskin DP, Podhasky J, Quijano VJ, Raczy C, Rae VH, Rawlings SR, Chiva Rodriguez A, Roe PM, Rogers J, Rogert Bacigalupo MC, Romanov N, Romieu A, Roth RK, Rourke NJ, Ruediger ST, Rusman E, Sanches-Kuiper RM, Schenker MR, Seoane JM, Shaw RJ, Shiver MK, Short SW, Sizto NL, Sluis JP, Smith MA, Ernest Sohna Sohna J, Spence EJ, Stevens K, Sutton N, Szajkowski L, Tregidgo CL, Turcatti G, Vandevondele S, Verhovsky Y, Virk SM, Wakelin S, Walcott GC, Wang J, Worsley GJ, Yan J, Yau L, Zuerlein M, Rogers J, Mullikin JC, Hurles ME, McCooke NJ, West JS, Oaks FL, Lundberg PL, Klenerman D, Durbin R, Smith AJ. Accurate whole human genome sequencing using reversible terminator chemistry. Nature. 2008 Nov 6;456(7218):53-9. doi: 10.1038/nature07517.

  PMID: 18987734 BACKGROUND

• Rothberg JM, Hinz W, Rearick TM, Schultz J, Mileski W, Davey M, Leamon JH, Johnson K, Milgrew MJ, Edwards M, Hoon J, Simons JF, Marran D, Myers JW, Davidson JF, Branting A, Nobile JR, Puc BP, Light D, Clark TA, Huber M, Branciforte JT, Stoner IB, Cawley SE, Lyons M, Fu Y, Homer N, Sedova M, Miao X, Reed B, Sabina J, Feierstein E, Schorn M, Alanjary M, Dimalanta E, Dressman D, Kasinskas R, Sokolsky T, Fidanza JA, Namsaraev E, McKernan KJ, Williams A, Roth GT, Bustillo J. An integrated semiconductor device enabling non-optical genome sequencing. Nature. 2011 Jul 20;475(7356):348-52. doi: 10.1038/nature10242.

  PMID: 21776081 BACKGROUND

• Chiu CY. Viral pathogen discovery. Curr Opin Microbiol. 2013 Aug;16(4):468-78. doi: 10.1016/j.mib.2013.05.001. Epub 2013 May 29.

  PMID: 23725672 BACKGROUND

• Quince C, Walker AW, Simpson JT, Loman NJ, Segata N. Shotgun metagenomics, from sampling to analysis. Nat Biotechnol. 2017 Sep 12;35(9):833-844. doi: 10.1038/nbt.3935.

  PMID: 28898207 BACKGROUND

• Naccache SN, Federman S, Veeraraghavan N, Zaharia M, Lee D, Samayoa E, Bouquet J, Greninger AL, Luk KC, Enge B, Wadford DA, Messenger SL, Genrich GL, Pellegrino K, Grard G, Leroy E, Schneider BS, Fair JN, Martinez MA, Isa P, Crump JA, DeRisi JL, Sittler T, Hackett J Jr, Miller S, Chiu CY. A cloud-compatible bioinformatics pipeline for ultrarapid pathogen identification from next-generation sequencing of clinical samples. Genome Res. 2014 Jul;24(7):1180-92. doi: 10.1101/gr.171934.113. Epub 2014 Jun 4.

  PMID: 24899342 BACKGROUND

• Snitkin ES, Zelazny AM, Thomas PJ, Stock F; NISC Comparative Sequencing Program Group; Henderson DK, Palmore TN, Segre JA. Tracking a hospital outbreak of carbapenem-resistant Klebsiella pneumoniae with whole-genome sequencing. Sci Transl Med. 2012 Aug 22;4(148):148ra116. doi: 10.1126/scitranslmed.3004129.

  PMID: 22914622 BACKGROUND

• Blauwkamp TA, Thair S, Rosen MJ, Blair L, Lindner MS, Vilfan ID, Kawli T, Christians FC, Venkatasubrahmanyam S, Wall GD, Cheung A, Rogers ZN, Meshulam-Simon G, Huijse L, Balakrishnan S, Quinn JV, Hollemon D, Hong DK, Vaughn ML, Kertesz M, Bercovici S, Wilber JC, Yang S. Analytical and clinical validation of a microbial cell-free DNA sequencing test for infectious disease. Nat Microbiol. 2019 Apr;4(4):663-674. doi: 10.1038/s41564-018-0349-6. Epub 2019 Feb 11.

  PMID: 30742071 BACKGROUND

• Miller S, Naccache SN, Samayoa E, Messacar K, Arevalo S, Federman S, Stryke D, Pham E, Fung B, Bolosky WJ, Ingebrigtsen D, Lorizio W, Paff SM, Leake JA, Pesano R, DeBiasi R, Dominguez S, Chiu CY. Laboratory validation of a clinical metagenomic sequencing assay for pathogen detection in cerebrospinal fluid. Genome Res. 2019 May;29(5):831-842. doi: 10.1101/gr.238170.118. Epub 2019 Apr 16.

  PMID: 30992304 BACKGROUND

• Schlaberg R, Chiu CY, Miller S, Procop GW, Weinstock G; Professional Practice Committee and Committee on Laboratory Practices of the American Society for Microbiology; Microbiology Resource Committee of the College of American Pathologists. Validation of Metagenomic Next-Generation Sequencing Tests for Universal Pathogen Detection. Arch Pathol Lab Med. 2017 Jun;141(6):776-786. doi: 10.5858/arpa.2016-0539-RA. Epub 2017 Feb 7.

  PMID: 28169558 BACKGROUND

• Pallen MJ. Diagnostic metagenomics: potential applications to bacterial, viral and parasitic infections. Parasitology. 2014 Dec;141(14):1856-62. doi: 10.1017/S0031182014000134. Epub 2014 Feb 27.

  PMID: 24576467 BACKGROUND

• Salipante SJ, Sengupta DJ, Rosenthal C, Costa G, Spangler J, Sims EH, Jacobs MA, Miller SI, Hoogestraat DR, Cookson BT, McCoy C, Matsen FA, Shendure J, Lee CC, Harkins TT, Hoffman NG. Rapid 16S rRNA next-generation sequencing of polymicrobial clinical samples for diagnosis of complex bacterial infections. PLoS One. 2013 May 29;8(5):e65226. doi: 10.1371/journal.pone.0065226. Print 2013.

  PMID: 23734239 BACKGROUND

• Wagner K, Springer B, Pires VP, Keller PM. Molecular detection of fungal pathogens in clinical specimens by 18S rDNA high-throughput screening in comparison to ITS PCR and culture. Sci Rep. 2018 May 3;8(1):6964. doi: 10.1038/s41598-018-25129-w.

  PMID: 29725065 BACKGROUND

• Quick J, Grubaugh ND, Pullan ST, Claro IM, Smith AD, Gangavarapu K, Oliveira G, Robles-Sikisaka R, Rogers TF, Beutler NA, Burton DR, Lewis-Ximenez LL, de Jesus JG, Giovanetti M, Hill SC, Black A, Bedford T, Carroll MW, Nunes M, Alcantara LC Jr, Sabino EC, Baylis SA, Faria NR, Loose M, Simpson JT, Pybus OG, Andersen KG, Loman NJ. Multiplex PCR method for MinION and Illumina sequencing of Zika and other virus genomes directly from clinical samples. Nat Protoc. 2017 Jun;12(6):1261-1276. doi: 10.1038/nprot.2017.066. Epub 2017 May 24.

  PMID: 28538739 BACKGROUND

• Briese T, Kapoor A, Mishra N, Jain K, Kumar A, Jabado OJ, Lipkin WI. Virome Capture Sequencing Enables Sensitive Viral Diagnosis and Comprehensive Virome Analysis. mBio. 2015 Sep 22;6(5):e01491-15. doi: 10.1128/mBio.01491-15.

  PMID: 26396248 BACKGROUND

• Metsky HC, Siddle KJ, Gladden-Young A, Qu J, Yang DK, Brehio P, Goldfarb A, Piantadosi A, Wohl S, Carter A, Lin AE, Barnes KG, Tully DC, Corleis B, Hennigan S, Barbosa-Lima G, Vieira YR, Paul LM, Tan AL, Garcia KF, Parham LA, Odia I, Eromon P, Folarin OA, Goba A; Viral Hemorrhagic Fever Consortium; Simon-Loriere E, Hensley L, Balmaseda A, Harris E, Kwon DS, Allen TM, Runstadler JA, Smole S, Bozza FA, Souza TML, Isern S, Michael SF, Lorenzana I, Gehrke L, Bosch I, Ebel G, Grant DS, Happi CT, Park DJ, Gnirke A, Sabeti PC, Matranga CB. Capturing sequence diversity in metagenomes with comprehensive and scalable probe design. Nat Biotechnol. 2019 Feb;37(2):160-168. doi: 10.1038/s41587-018-0006-x. Epub 2019 Feb 4.

  PMID: 30718881 BACKGROUND

• Stefan CP, Koehler JW, Minogue TD. Targeted next-generation sequencing for the detection of ciprofloxacin resistance markers using molecular inversion probes. Sci Rep. 2016 May 13;6:25904. doi: 10.1038/srep25904.

  PMID: 27174456 BACKGROUND

• Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.

  PMID: 30918369 BACKGROUND

• Naccache SN, Peggs KS, Mattes FM, Phadke R, Garson JA, Grant P, Samayoa E, Federman S, Miller S, Lunn MP, Gant V, Chiu CY. Diagnosis of neuroinvasive astrovirus infection in an immunocompromised adult with encephalitis by unbiased next-generation sequencing. Clin Infect Dis. 2015 Mar 15;60(6):919-23. doi: 10.1093/cid/ciu912. Epub 2015 Jan 7.

  PMID: 25572898 BACKGROUND

• Fukui Y, Aoki K, Okuma S, Sato T, Ishii Y, Tateda K. Metagenomic analysis for detecting pathogens in culture-negative infective endocarditis. J Infect Chemother. 2015 Dec;21(12):882-4. doi: 10.1016/j.jiac.2015.08.007. Epub 2015 Sep 8.

  PMID: 26360016 BACKGROUND

• Ortiz-Alcantara JM, Segura-Candelas JM, Garces-Ayala F, Gonzalez-Duran E, Rodriguez-Castillo A, Alcantara-Perez P, Wong-Arambula C, Gonzalez-Villa M, Leon-Avila G, Garcia-Chequer AJ, Diaz-Quinonez JA, Mendez-Tenorio A, Ramirez-Gonzalez JE. Fatal Psychrobacter sp. infection in a pediatric patient with meningitis identified by metagenomic next-generation sequencing in cerebrospinal fluid. Arch Microbiol. 2016 Mar;198(2):129-35. doi: 10.1007/s00203-015-1168-2. Epub 2015 Nov 6.

  PMID: 26546315 BACKGROUND

• Wylie KM, Blanco-Guzman M, Wylie TN, Lawrence SJ, Ghobadi A, DiPersio JF, Storch GA. High-throughput sequencing of cerebrospinal fluid for diagnosis of chronic Propionibacterium acnes meningitis in an allogeneic stem cell transplant recipient. Transpl Infect Dis. 2016 Apr;18(2):227-33. doi: 10.1111/tid.12512. Epub 2016 Mar 31.

  PMID: 26895706 BACKGROUND

• Leo S, Gaia N, Ruppe E, Emonet S, Girard M, Lazarevic V, Schrenzel J. Detection of Bacterial Pathogens from Broncho-Alveolar Lavage by Next-Generation Sequencing. Int J Mol Sci. 2017 Sep 20;18(9):2011. doi: 10.3390/ijms18092011.

  PMID: 28930150 BACKGROUND

• Pendleton KM, Erb-Downward JR, Bao Y, Branton WR, Falkowski NR, Newton DW, Huffnagle GB, Dickson RP. Rapid Pathogen Identification in Bacterial Pneumonia Using Real-Time Metagenomics. Am J Respir Crit Care Med. 2017 Dec 15;196(12):1610-1612. doi: 10.1164/rccm.201703-0537LE. No abstract available.

  PMID: 28475350 BACKGROUND

• Li Y, Sun B, Tang X, Liu YL, He HY, Li XY, Wang R, Guo F, Tong ZH. Application of metagenomic next-generation sequencing for bronchoalveolar lavage diagnostics in critically ill patients. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):369-374. doi: 10.1007/s10096-019-03734-5. Epub 2019 Dec 7.

  PMID: 31813078 BACKGROUND

• Chen Y, Feng W, Ye K, Guo L, Xia H, Guan Y, Chai L, Shi W, Zhai C, Wang J, Yan X, Wang Q, Zhang Q, Li C, Liu P, Li M. Application of Metagenomic Next-Generation Sequencing in the Diagnosis of Pulmonary Infectious Pathogens From Bronchoalveolar Lavage Samples. Front Cell Infect Microbiol. 2021 Mar 11;11:541092. doi: 10.3389/fcimb.2021.541092. eCollection 2021.

  PMID: 33777827 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start: November 20, 2023
• Primary Completion (Estimated): April 9, 2028
• Study Completion (Estimated): April 9, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)