Jan 09, 2024

Public workspaceOptimizing patient outcomes in severe pneumonia: Timing of Multiplex PCR in critically ill pa-tients V.1

DOI
dx.doi.org/10.17504/protocols.io.eq2lyj59mlx9/v1
  • Jia-Hao Zhang1,
  • Hou-Tai Chang1
  • 1Department of Critical Care Medicine, Far Eastern Memorial Hospital, Taipei 220216, Taiwan
張 美雲
Open access
DOI: dx.doi.org/10.17504/protocols.io.eq2lyj59mlx9/v1
Protocol Citation: Jia-Hao Zhang, Hou-Tai Chang 2024. Optimizing patient outcomes in severe pneumonia: Timing of Multiplex PCR in critically ill pa-tients. protocols.io https://dx.doi.org/10.17504/protocols.io.eq2lyj59mlx9/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: January 08, 2024
Last Modified: January 09, 2024
Protocol Integer ID: 93047
Funders Acknowledgement:
FEMH
Grant ID: 2023-C-020
FEMH
Grant ID: YZU-2023-002.
Disclaimer
The authors declare no conflict of interest.
Abstract
The impact of multiplex PCR on the mortality rate of patients with severe pneumonia in the intensive care unit remains uncertain. Hence, this retrospective cohort study sought to ascertain the most effective timing for implementing multiplex polymerase chain reaction (PCR) in the management of patients with severe pneumonia, and to assess its potential to improve the survival rate of these patients. Patients admitted to the medical intensive care unit (MICU) with acute respiratory failure and severe pneumonia were included in accordance with the diagnostic criteria outlined by the Infectious Diseases Society of America (IDSA). Through the analysis of these factors, this study aimed to provide valuable insights into the management of severe pneumonia cases.
Materials
This retrospective single-center cohort study was conducted at a medical center in Taiwan between July 1, 2021 and October26, 2022. This study used anonymous data and was approved by the Medical Ethics Committee of the Far Eastern Memorial Hospital (approval number: 111211-E). Patients admitted to the medical intensive care unit (MICU) with acute respiratory failure and severe pneumo-nia were included in accordance with the diagnostic criteria outlined by the Infectious Diseases Society of America (IDSA). These criteria necessitated the presence of either new or progressive chest X-ray consolidations combined with clinical symptoms, such as dyspnea, cough, sputum production, fever, and abnormal breathing sounds indicative of pulmonary consolidation. The effects of these factors on patient outcomes were subsequently investigated [6, 13]. Spe-cific exclusion criteria were implemented to maintain a focused analysis. Patients who did not receive invasive me-chanical ventilation were excluded. Additionally, those who died within 3 days after undergoing FA-PP examination were not considered, nor were patients with hospital stays exceeding 90 days.
Study population

Number of Subjects Enrolled: 110 patients from Far Eastern Hospital.
  1. Inclusion Criteria:(1)Patients admitted to the medical intensive care unit (MICU) with acute respiratory failure and severe pneumonia were included in accordance with the diagnostic criteria outlined by the Infectious Diseases Society of America (IDSA). (2)These criteria necessitated the presence of either new or progressive chest X-ray consolidations combined with clinical symptoms, such as dyspnea, cough, sputum production, fever, and abnormal breathing sounds indicative of pulmonary consolidation. (3)Age greater than or equal to 20 years.
  2. Exclusion criteria : (1)Patients who did not receive invasive mechanical ventilation were excluded. (2)Those who died within 3 days after undergoing FA-PP examination were not considered. (3)Patients with hospital stays exceeding 90 days.
  3. This retrospective single-center cohort study was conducted at a medical center in Taiwan between July 1, 2021 and October26, 2022. This study used anonymous data and was approved by the Medical Ethics Committee of the Far Eastern Memorial Hospital (approval number: 111211-E)
Data collection
  1. As a retrospective study, data will be collected from July 1, 2021, to October 26, 2022.
  2. Data Collection includes Age, Gender, APACHE II, Smoking status, Past history, Admission date, ICU date, Diagnosis date, Intubation date, Duration of intubation days, Duration of ICU days, Duration of hospital days, Outcome (survival or mortality upon discharge), Antibiotics, Sputum culture date, Sputum culture result, Sputum FilmArray date, Sputum FilmArray result, Antibiotics adjustment (including Escalation and De-escalation).
  3. Follow-up or necessary rehabilitation plans for subjects: Case tracking will be conducted from July 1, 2021, to October 26, 2022.
  4. Based on lower respiratory tract microbiological culture and Multiplex PCR analysis, patients will be categorized into those with consistent or inconsistent results between microbiological culture and Multiplex PCR analysis. The adjustment of antibiotics will be assessed in relation to patient prognosis.
  5. For critically ill pneumonia patients, the time from diagnosis to the report generated by Multiplex PCR will be analyzed to determine its association with patient outcomes.

Statistical analysis
Statistical analyses were performed using SPSS Statistics software version 19 (IBM Corp.Armonk, NY, USA). The primary analytical methods employed the chi-square test to compare categorical data while continuous data were compared using Student's t-test.We further performed a univariate analysis to identify potential risk factors associated with mortality in patients with severe pneumonia. The chi-square test was used for categorical data and Student's t-test was used for continuous data. Factors exhibiting p-values less than 0.05 were deemed statistically significant, and subsequently included in the multivariate logistic regression model. Statistical significance was defined as a p-value less than 0.05.
Protocol references
1.Garcia-Vidal, C.; Fernandez-Sabe, N.; Carratala, J.; Diaz, V.; Verdaguer, R.; Dorca, J. et al. Early mortality in patients with communi-ty-acquired pneumonia causes and risk factors. Eur Respir J 2008, 32(3), 733-9. DOI: 10.1183/09031936.00128107
2.Zhang, Z,X.; Yong, Y.; Tan, W.C.; Shen, L.; Ng, H.S.; Fong, K.Y. Prognostic factors for mortality due to pneumonia among adults of different age groups in Singapore and mortality predictions based on the PSI and CURB-65. Singapore Med J 2018, 59(4), 190-8. DOI: 10.11622/smedj.2017079
3.Lat, I.; Daley, M.J.; Shewale, A.; Pangrazzi, M.H.; Hammond, D.; Olsen, K.M. et al. A multicenter, prospective, ob-servational study to determine predictive factors for Multidrug-Resistant pneumonia in critically ill adults: the DEFINE study. Pharmacotherapy 2019, 39(3), 253-60. DOI:: 10.1002/phar.2171
4.Ryan, K.; Karve, S.; Peeters, P.; Baelen, E.; Potter, D.; Rojas-Farreras, S. et al. Impact of initial antibiotic treat-ment failure: re-al-world insights into healthcare-associated or nosocomial pneumonia. J Infect 2018, 77(1), 9-17. DOI: 10.1016/j.jinf.2018.04.002
5.Oliveira, A.B.S.; Sacillotto, G.H.; Neves, M.F.B.; Silva, A.; Moimaz, T.A.; Gandolfi, J.V. et al. Prevalence, Outcomes, and Predictors of multidrug-resistant Nosocomial Lower Respiratory Tract Infections in ICU Patients. J Bras Pneumol 2023, 49(1), e20220235.DOI: 10.36416/1806-3756/e20220235. 10.36416/1806-3756/e20220235
6.Metlay, J.P.; Waterer, G.W.; Long, A.C.; Anzueto, A.; Brozek, J.; Crothers, K. et al. Diagnosis and treatment of adults with Commu-nity-acquired Pneumonia. Official Clinical Practice Guidelines of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med 2019, 200(7), e45-e67.DOI: 10.1164/rccm.201908-1581ST
7.García-Vázquez, E.; Marcos, M.A.; Mensa, J.; de Roux, A.; Puig, J.; Font, C. et al. Assessment of the usefulness of spu-tum culture in the diagnosis of community-acquired pneumonia using the PORT predictive scoring system. Arch Intern Med 2004, 164(16), 1807-11. DOI: 10.1001/archinte.164.16.1807
8.Monard, C.; Pehlivan, J.; Auger, G.; Alviset, S.; Tran Dinh, A.; Duquaire, P. et al. Multicenter evaluation of a syn-dromic rapid mul-tiplex PCR test for early adaptation to antimicrobial therapy in adult patients with pneumonia. Crit Care 2020, 24(1), 434.DOI: 10.1186/s13054-020-03114-y.
9.Gastli N, Loubinoux J, Daragon M, Lavigne JP, Saint-Sardos P, Pailhories H, et al. Multicenter evaluation of the BioFire FilmArray Pneumonia Panel for the rapid bacteriological documentation of pneumonia. Clin Microbiol Infect 2021, 27(9),1308-14.DOI: 10.1016/j.cmi.2020.11.014
10.Serigstad, S.; Markussen, D.; Grewal, H.M.S.; Ebbesen, M.; Kommedal, O.; Heggelund, L. et al. Rapid syndromic PCR testing in patients with respiratory tract infections reduces the time to obtain results and improves microbial yield. Sci Rep 2022, 12(1), 326.DOI: 10.1038/s41598-021-03741-7
11.Buchan, B.W.; Windham, S.; Balada-Llasat, J.M.; Leber, A.; Harrington, A.; Relich, R. et al. Practical comparison of the biofire film array pneumonia panel to routine diagnostic methods and its potential impact on antimicrobial stewardship in adult hospitalized patients with lower respiratory tract infections. J Clin Microbiol 2020, 58(7).DOI: 10.1128/JCM.00135-20
12.Peiffer-Smadja, N.; Bouadma, L.; Mathy, V.; Allouche, K.; Patrier, J.; Reboul, M. et al. Performance and impact of multiplex PCR in ICU patients with ventilator-associated pneumonia or hospital-acquired pneumonia. Crit Care 2020, 24(1), 366.DOI: 10.1186/s13054-020-03067-2
13.Kalil, A.C.; Metersky, M.L.; Klompas, M.; Muscedere, J.; Sweeney, D.A.; Palmer, L.B. et al. Management of Adults With Hos pital-acquired and Ventilator-associated Pneumonia:2016 Clinical Practice Guidelines by the Infectious Dis-eases Society of America and the American Thoracic Society. Clin Infect Dis 2016, 63(5), e61-e111. DOI: 10.1093/cid/ciw353
14. Evans, L.; Rhodes, A.; Alhazzani, W.; Antonelli, M.; Coopersmith, C.M.; French, C. et al. Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock, 2021. Crit Care Med 2021, 49(11), e1063-e143. DOI: 10.1097/CCM.0000000000005337
15.Knaus, W,A.; Draper, E.A.; Wagner, D.P. et al. APACHE II: Severity of disease classification system. Crit Care Med 1985, 13(10), 818-29. PMID: 3928249
16.Richards, G.; Levy, H.; Laterre, P.F.; Feldman, C.; Woodward, B.; Bates, B.M. et al. CURB-65, PSI, and APACHE II were used to as-sess mortality risk in patients with severe sepsis and community-acquired pneumonia in PROWESS. J Intensive Care Med 2011, 26(1), 34-40. DOI: 10.1177/0885066610383949
17.Tian, Y.; Yao, Y.; Zhou, J.; Diao, X.; Chen, H.; Cai, K. et al. Dynamic APACHE II score to predict the outcome of Intensive Care Unit patients. Front Med (Lausanne) 2021, 8, 744907.DOI: 10.3389/fmed.2021.744907
18.Fine, M.J.; Auble, T.E., Yealy, D.M.; Hanusa, B.H.; Weissfeld, L.A.; Singer, D.E. et al. Predictive rules for identifying low-risk pa-tients with community-acquired pneumonia. N Engl J Med 1997, 336(4), 243-50. DOI: 10.1056/NEJM199701233360402
19.Shah, B.A.; Ahmed, W.; Dhobi, G.N.; Shah, N.N.; Khursheed, S.Q. et al.. Validity of pneumonia severity index and CURB-65 se-verity scoring systems in community-acquired pneumonia in an Indian setting. Indian J Chest Dis Allied Sci. 2010;52(1):9-17. PMID: 20364609
20.Guillotin F, Poulain C, Gaborit B, Bouras M, Cinotti R, Lakhal K, et al. Potential Impact of Rapid Multiplex PCR on Antimicrobial Therapy Guidance for Ventilated Hospital-Acquired Pneumonia in Critically Ill Patients, A Prospective Ob-servational Clinical and Economic Study. Front Cell Infect Microbiol 2022, 12, 804611.DOI: 10.3389/fcimb.2022.804611
21.Ferrer, J.; Clari, M.A.; Gimenez, E.; Carbonell, N.; Torres, I.; Blasco, M.L,. et al. Biofire(R) Filmarray(R) Pneumonia Plus panel for management of lower respiratory tract infection in mechanically-ventilated patients in the COVID-19 era: a diagnostic and cost-benefit evaluation. Diagn Microbiol Infect Dis 2023, 105(2), 115847.DOI: 10.1016/j.diagmicrobio.2022.115847
22.Clark, T.W.; Lindsley, K.; Wigmosta, T.B.; Bhagat, A.; Hemmert, R.B.; Uyei, J. et al. Rapid multiplex PCR for respiratory viruses re-duces the time required to obtain results and improves clinical care. J Infect 2023, 86(5), 462-75. DOI: 10.1016/j.jinf.2023.03.005