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| Name | Class |
|---|---|
| Western Michigan University | OTHER |
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The objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock.
This study will involve 8 centers is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock. The study team will compare two sequential 4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one 'conservative' antimicrobial initiation period.
This study will serve the following specific aims:
Specific Aim 1: To determine feasibility of a larger multicenter study of the same design as well as assess protocol adherence across multiple centers.
Specific Aim 2: Prospectively determine the all-cause, in-hospital mortality for all patients with suspected pneumonia who were treated under either an aggressive or conservative antimicrobial initiation protocol.
Specific Aim 3: Prospectively determine antimicrobial initiation rates, total days of antimicrobial administration, hospital and ICU length of stay, and ventilator-free alive days for patients treated under each protocol.
Specific Aim 4: To survey physicians that participated in the study to assess their feelings about the study including level of comfort starting antimicrobials aggressively, level of comfort withholding antimicrobials until definitive evidence of infection, perceived protocol adherence, perceived importance of the study, and willingness to participate in other studies of its kind (to be performed after closure of the clinical portion of the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggressive Arm | Other | If an intubated patient is suspected of having an ICU-acquired HAP/VAP during the aggressive period, antimicrobials should be initiated immediately after quantitative or semi-quantitative endobronchial cultures are sent regardless of clinical status. This will include patients who, as determined by the attending intensivist, are in sepsis or septic shock. If, after 72 hours, cultures and other clinical data do not point to a pneumonia, the antimicrobials should be stopped in the absence of another source of infection. |
|
| Conservative Arm | Other | If a patient is suspected of having an ICU-acquired HAP/VAP during the conservative period, quantitative or semi-quantitative endobronchial cultures should be sent. If the patient is in septic shock persistent hypotension requiring vasoactive medications to maintain mean arterial pressure (MAP) ≥65 mm HG or persistent lactic acidosis (>2 mmol/L) despite adequate resuscitation) antimicrobials will be initiated immediately. If the patient has new onset organ dysfunction that is presumed to be due to infection (sepsis) then antimicrobials will be initiated at the discretion of the attending intensivist. In the absence of septic shock or sepsis (intensivist discretion), antimicrobials will not be initiated unless objective evidence of pneumonia is present or another documented source of infection is identified mandating treatment with antimicrobials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antimicrobial initiation | Other | antimicrobial initiation based on protocol assignment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| protocol adherence | as a pilot study the primary outcome will be protocol adherence as defined by using the criteria below: Aggressive Protocol:
Conservative Protocol:
| by time of culture finalization or 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related | until hospital discharge or 1 year |
| Days of antimicrobials administered | includes empiric, therapeutic, prophylactic, and perioperative antimicrobials |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Guidry | KU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22951600 | Background | Hranjec T, Rosenberger LH, Swenson B, Metzger R, Flohr TR, Politano AD, Riccio LM, Popovsky KA, Sawyer RG. Aggressive versus conservative initiation of antimicrobial treatment in critically ill surgical patients with suspected intensive-care-unit-acquired infection: a quasi-experimental, before and after observational cohort study. Lancet Infect Dis. 2012 Oct;12(10):774-80. doi: 10.1016/S1473-3099(12)70151-2. Epub 2012 Aug 28. | |
| 23524477 |
| Label | URL |
|---|---|
| Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot | View source |
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aggregated study results
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| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.
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| until hospital discharge or 1 year |
| Ventilator-free alive days | until hospital discharge or 1 year |
| ICU length of stay | Until discharge from ICU or 1 year |
| Hospital length of stay | until hospital discharge or 1 year |
| Background |
| Barbier F, Andremont A, Wolff M, Bouadma L. Hospital-acquired pneumonia and ventilator-associated pneumonia: recent advances in epidemiology and management. Curr Opin Pulm Med. 2013 May;19(3):216-28. doi: 10.1097/MCP.0b013e32835f27be. |
| 28890434 | 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. |
| 26938612 | Background | Leonard KL, Borst GM, Davies SW, Coogan M, Waibel BH, Poulin NR, Bard MR, Goettler CE, Rinehart SM, Toschlog EA. Ventilator-Associated Pneumonia in Trauma Patients: Different Criteria, Different Rates. Surg Infect (Larchmt). 2016 Jun;17(3):363-8. doi: 10.1089/sur.2014.076. Epub 2016 Mar 3. |
| 30553458 | Background | Krebs ED, Hassinger TE, Guidry CA, Berry PS, Elwood NR, Sawyer RG. Non-utility of sepsis scores for identifying infection in surgical intensive care unit patients. Am J Surg. 2019 Aug;218(2):243-247. doi: 10.1016/j.amjsurg.2018.11.044. Epub 2018 Dec 8. |
| 30885453 | Background | Eguia E, Cobb AN, Baker MS, Joyce C, Gilbert E, Gonzalez R, Afshar M, Churpek MM. Risk factors for infection and evaluation of Sepsis-3 in patients with trauma. Am J Surg. 2019 Nov;218(5):851-857. doi: 10.1016/j.amjsurg.2019.03.005. Epub 2019 Mar 8. |
| 30978329 | Background | Anand V, Zhang Z, Kadri SS, Klompas M, Rhee C; CDC Prevention Epicenters Program. Epidemiology of Quick Sequential Organ Failure Assessment Criteria in Undifferentiated Patients and Association With Suspected Infection and Sepsis. Chest. 2019 Aug;156(2):289-297. doi: 10.1016/j.chest.2019.03.032. Epub 2019 Apr 9. |
| 26556896 | Background | Piriyapatsom A, Lin H, Pirrone M, De Pascale G, Corona De Lapuerta J, Bittner EA, Schmidt UH, De Moya M, Berra L. Evaluation of the Infection-Related Ventilator-Associated Events Algorithm for Ventilator-Associated Pneumonia Surveillance in a Trauma Population. Respir Care. 2016 Mar;61(3):269-76. doi: 10.4187/respcare.04280. Epub 2015 Nov 10. |
| 26207397 | Background | Pieracci FM, Rodil M, Haenel J, Stovall RT, Johnson JL, Burlew CC, Jurkovich GJ, Moore EE. Screening for Ventilator-Associated Pneumonia in the Surgical Intensive Care Unit: A Single-Institution Analysis of 1,013 Lower Respiratory Tract Cultures. Surg Infect (Larchmt). 2015 Aug;16(4):368-74. doi: 10.1089/sur.2014.086. Epub 2015 May 28. |
| 25314257 | Background | Carraro E, Cook C, Evans D, Stawicki S, Postoev A, Olcese V, Phillips G, Eiferman D. Lack of added predictive value of portable chest radiography in diagnosing ventilator-associated pulmonary infection. Surg Infect (Larchmt). 2014 Dec;15(6):739-44. doi: 10.1089/sur.2013.239. |
| 16531849 | Background | Croce MA, Swanson JM, Magnotti LJ, Claridge JA, Weinberg JA, Wood GC, Boucher BA, Fabian TC. The futility of the clinical pulmonary infection score in trauma patients. J Trauma. 2006 Mar;60(3):523-7; discussion 527-8. doi: 10.1097/01.ta.0000204033.78125.1b. |
| 29580362 | Background | Quick JA, Breite MD, Barnes SL. Inadequacy of Algorithmic Ventilator-Associated Pneumonia Diagnosis in Acute Care Surgery. Am Surg. 2018 Feb 1;84(2):300-304. |
| 27418577 | Background | Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. |
| 15090974 | Background | Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4. |
| 28098591 | Background | Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255. |
| 15865550 | Background | Barie PS, Hydo LJ, Shou J, Larone DH, Eachempati SR. Influence of antibiotic therapy on mortality of critical surgical illness caused or complicated by infection. Surg Infect (Larchmt). 2005 Spring;6(1):41-54. doi: 10.1089/sur.2005.6.41. |
| 16625125 | Background | Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9. |
| 20029343 | Background | Barochia AV, Cui X, Vitberg D, Suffredini AF, O'Grady NP, Banks SM, Minneci P, Kern SJ, Danner RL, Natanson C, Eichacker PQ. Bundled care for septic shock: an analysis of clinical trials. Crit Care Med. 2010 Feb;38(2):668-78. doi: 10.1097/CCM.0b013e3181cb0ddf. |
| 20048677 | Background | Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824. |
| 24717459 | Background | Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330. |
| 27635693 | Background | Loftus TJ, Brakenridge SC, Moore FA, Lemon SJ, Nguyen LL, Voils SA, Jordan JR, Croft CA, Smith RS, Efron PA, Mohr AM. Intubated Trauma Patients Receiving Prolonged Antibiotics for Pneumonia despite Negative Cultures: Predictors and Outcomes. Surg Infect (Larchmt). 2016 Dec;17(6):766-772. doi: 10.1089/sur.2016.108. Epub 2016 Sep 16. |
| 30242350 | Background | Klompas M, Calandra T, Singer M. Antibiotics for Sepsis-Finding the Equilibrium. JAMA. 2018 Oct 9;320(14):1433-1434. doi: 10.1001/jama.2018.12179. No abstract available. |
| 30726686 | Background | Mi MY, Klompas M, Evans L. Early Administration of Antibiotics for Suspected Sepsis. N Engl J Med. 2019 Feb 7;380(6):593-596. doi: 10.1056/NEJMclde1809210. No abstract available. |
| 30883190 | Background | Prescott HC, Iwashyna TJ. Improving Sepsis Treatment by Embracing Diagnostic Uncertainty. Ann Am Thorac Soc. 2019 Apr;16(4):426-429. doi: 10.1513/AnnalsATS.201809-646PS. No abstract available. |
| 29196046 | Background | Alam N, Oskam E, Stassen PM, Exter PV, van de Ven PM, Haak HR, Holleman F, Zanten AV, Leeuwen-Nguyen HV, Bon V, Duineveld BAM, Nannan Panday RS, Kramer MHH, Nanayakkara PWB; PHANTASi Trial Investigators and the ORCA (Onderzoeks Consortium Acute Geneeskunde) Research Consortium the Netherlands. Prehospital antibiotics in the ambulance for sepsis: a multicentre, open label, randomised trial. Lancet Respir Med. 2018 Jan;6(1):40-50. doi: 10.1016/S2213-2600(17)30469-1. Epub 2017 Nov 28. |
| 24589043 | Background | Bloos F, Thomas-Ruddel D, Ruddel H, Engel C, Schwarzkopf D, Marshall JC, Harbarth S, Simon P, Riessen R, Keh D, Dey K, Weiss M, Toussaint S, Schadler D, Weyland A, Ragaller M, Schwarzkopf K, Eiche J, Kuhnle G, Hoyer H, Hartog C, Kaisers U, Reinhart K; MEDUSA Study Group. Impact of compliance with infection management guidelines on outcome in patients with severe sepsis: a prospective observational multi-center study. Crit Care. 2014 Mar 3;18(2):R42. doi: 10.1186/cc13755. |
| 30466493 | Background | Abe T, Ogura H, Shiraishi A, Kushimoto S, Saitoh D, Fujishima S, Mayumi T, Shiino Y, Nakada TA, Tarui T, Hifumi T, Otomo Y, Okamoto K, Umemura Y, Kotani J, Sakamoto Y, Sasaki J, Shiraishi SI, Takuma K, Tsuruta R, Hagiwara A, Yamakawa K, Masuno T, Takeyama N, Yamashita N, Ikeda H, Ueyama M, Fujimi S, Gando S; JAAM FORECAST group. Characteristics, management, and in-hospital mortality among patients with severe sepsis in intensive care units in Japan: the FORECAST study. Crit Care. 2018 Nov 22;22(1):322. doi: 10.1186/s13054-018-2186-7. |
| 25925412 | Background | de Groot B, Ansems A, Gerling DH, Rijpsma D, van Amstel P, Linzel D, Kostense PJ, Jonker M, de Jonge E. The association between time to antibiotics and relevant clinical outcomes in emergency department patients with various stages of sepsis: a prospective multi-center study. Crit Care. 2015 Apr 29;19(1):194. doi: 10.1186/s13054-015-0936-3. |
| 23539143 | Background | Kaasch AJ, Rieg S, Kuetscher J, Brodt HR, Widmann T, Herrmann M, Meyer C, Welte T, Kern P, Haars U, Reuter S, Hubner I, Strauss R, Sinha B, Brunkhorst FM, Hellmich M, Fatkenheuer G, Kern WV, Seifert H; preSABATO study group. Delay in the administration of appropriate antimicrobial therapy in Staphylococcus aureus bloodstream infection: a prospective multicenter hospital-based cohort study. Infection. 2013 Oct;41(5):979-85. doi: 10.1007/s15010-013-0428-9. Epub 2013 Mar 29. |
| 36534474 | Derived | Guidry CA, Beyene RT, Watson CM, Sawyer RG, Chollet-Hinton L, Simpson SQ, Atchison L, Derickson M, Cooper LC, Pennington GP 2nd, VandenBerg S, Halimeh BN, O'Dell JC. Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot. J Trauma Acute Care Surg. 2023 Feb 1;94(2):232-240. doi: 10.1097/TA.0000000000003839. Epub 2022 Nov 18. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |