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Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia
Patients who are more than 18 years old who are admitted to Neurosurgical ICU will be recruited 48hours after ventilation if matches criteria for ventilator associated pneumonia. Patients will be randomised into 2 groups. first group will be procalcitonin guided in addition to conventionally guided sepsis assessment (TWC, CRP, body temperature). second group is only conventionally guided sepsis assessment. in procalcitonin guided group, blood sample will be taken on Day 1 of recruitment and day 5. On day 5 , the procalcitonin level will be compared to recommendations in PRORATA trial. If procalcitonin level is below the level to withhold antibiotics, recommendation will be made to the primary physician to off the antibiotics. Another Procalcitonin level will be repeated on Day 7 to rule out reinfection. This study aims to compare the duration of antibiotics and length of ICU stay among the 2 groups.
This study will fill up the gap among the lack of datas in neurosurgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin guided antibiotics treatment duration | Experimental | Procalcitonin test in addition to standard care blood investigations |
|
| Standard care guided antibiotics treatment duration | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shorten antibiotics duration based on procalcitonin test levels | Diagnostic Test | procalcitonin test will be taken on day 1 of recruitment as baseline, test done on day 5 will decide whether antibiotics will be withheld, followed by day 7 to determine rate of reinfection. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic | compare the duration of antibiotics between 2 arms | 14 days |
| To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic | compare the length of ICU stay in between 2 arms | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To compare 14 days mortality rate in between 2 arms | compare 14 days mortality rate in between 2 arms | 14 days |
| To compare proportion of difficult to treat organisms (MRO) in between 2 arms | compare proportion of difficult to treat organisms (MRO) in between 2 arms |
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Inclusion Criteria:
Exclusion Criteria:
Adults more than 18 years old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerome Loh | Contact | +60128589099 | jeromederyang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zulfakar Mazlan | Associated Professor Dr | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29982303 | Background | Bonell A, Azarrafiy R, Huong VTL, Viet TL, Phu VD, Dat VQ, Wertheim H, van Doorn HR, Lewycka S, Nadjm B. A Systematic Review and Meta-analysis of Ventilator-associated Pneumonia in Adults in Asia: An Analysis of National Income Level on Incidence and Etiology. Clin Infect Dis. 2019 Jan 18;68(3):511-518. doi: 10.1093/cid/ciy543. | |
| 32157357 |
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In a parallel group design, participants are randomized to two groups (PCT guided versus Non PCT guided (standard of care).
Each group receives a different intervention (e.g., pct vs crp, tw, blood culture, temperature and clinical).
The groups are compared to assess the effectiveness of the interventions.
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| 14 days |
| To compare the proportion of reinfection within 72 hours after stopping antibiotics | compare the proportion of reinfection within 72 hours after stopping antibiotics | 14 days |
| Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med. 2020 May;46(5):888-906. doi: 10.1007/s00134-020-05980-0. Epub 2020 Mar 10. |
| 28480245 | Background | Rhee C. Using Procalcitonin to Guide Antibiotic Therapy. Open Forum Infect Dis. 2016 Dec 7;4(1):ofw249. doi: 10.1093/ofid/ofw249. eCollection 2017 Winter. |
| 18470710 | Background | Brunkhorst FM, Wegscheider K, Forycki ZF, Brunkhorst R. Procalcitonin for early diagnosis and differentiation of SIRS, sepsis, severe sepsis, and septic shock. Intensive Care Med. 2000 Mar;26 Suppl 2:S148-52. doi: 10.1007/BF02900728. |
| 19034493 | Background | Schroeder S, Hochreiter M, Koehler T, Schweiger AM, Bein B, Keck FS, von Spiegel T. Procalcitonin (PCT)-guided algorithm reduces length of antibiotic treatment in surgical intensive care patients with severe sepsis: results of a prospective randomized study. Langenbecks Arch Surg. 2009 Mar;394(2):221-6. doi: 10.1007/s00423-008-0432-1. Epub 2008 Nov 26. |
| 34006044 | Background | Z Mazlan M, A H Ismail M, Ali S, Salmuna ZN, Wan Muhd Shukeri WF, Omar M. Efficacy and safety of the point-of-care procalcitonin test for determining the antibiotic treatment duration in patients with ventilator-associated pneumonia in the intensive care unit: a randomised controlled trial. Anaesthesiol Intensive Ther. 2021;53(3):207-214. doi: 10.5114/ait.2021.104300. |
| 20097417 | Background | Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25. |
| 34177168 | Background | Vishalashi SG, Gupta P, Verma PK. Serum Procalcitonin as a Biomarker to Determine the Duration of Antibiotic Therapy in Adult Patients with Sepsis and Septic Shock in Intensive Care Units: A Prospective Study. Indian J Crit Care Med. 2021 May;25(5):507-511. doi: 10.5005/jp-journals-10071-23802. |
| 26553084 | Background | Najafi A, Khodadadian A, Sanatkar M, Shariat Moharari R, Etezadi F, Ahmadi A, Imani F, Khajavi MR. The Comparison of Procalcitonin Guidance Administer Antibiotics with Empiric Antibiotic Therapy in Critically Ill Patients Admitted in Intensive Care Unit. Acta Med Iran. 2015;53(9):562-7. |
| 16603606 | Background | Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7. |
| 23418298 | Background | Annane D, Maxime V, Faller JP, Mezher C, Clec'h C, Martel P, Gonzales H, Feissel M, Cohen Y, Capellier G, Gharbi M, Nardi O. Procalcitonin levels to guide antibiotic therapy in adults with non-microbiologically proven apparent severe sepsis: a randomised controlled trial. BMJ Open. 2013 Feb 14;3(2):e002186. doi: 10.1136/bmjopen-2012-002186. Print 2013. |
| 19493352 | Background | Hochreiter M, Kohler T, Schweiger AM, Keck FS, Bein B, von Spiegel T, Schroeder S. Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomized prospective controlled trial. Crit Care. 2009;13(3):R83. doi: 10.1186/cc7903. Epub 2009 Jun 3. |
| 19529989 | Background | Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584. |
| 29271844 | Background | Iankova I, Thompson-Leduc P, Kirson NY, Rice B, Hey J, Krause A, Schonfeld SA, DeBrase CR, Bozzette S, Schuetz P. Efficacy and Safety of Procalcitonin Guidance in Patients With Suspected or Confirmed Sepsis: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 May;46(5):691-698. doi: 10.1097/CCM.0000000000002928. |
| 21398306 | Background | Kibe S, Adams K, Barlow G. Diagnostic and prognostic biomarkers of sepsis in critical care. J Antimicrob Chemother. 2011 Apr;66 Suppl 2:ii33-40. doi: 10.1093/jac/dkq523. |
| 38456106 | Background | Mazlan MZ, Ghazali AG, Omar M, Yaacob NM, Nik Mohamad NA, Hassan MH, Wan Muhd Shukeri WF. Predictors of Treatment Failure and Mortality among Patients with Septic Shock Treated with Meropenem in the Intensive Care Unit. Malays J Med Sci. 2024 Feb;31(1):76-90. doi: 10.21315/mjms2024.31.1.7. Epub 2024 Feb 28. |
| 34031334 | Background | Nik Nurfazleen MZ, Mohamad Hasyizan H, Laila Ab M, Zeti Norfidiyati S, Kamaruddin I, Mahamarowi O, Mohd Zulfakar M. Clinical characteristics and factors associated with diagnoses of ventilator and non-ventilator associated pneumonia in Intensive care unit. Med J Malaysia. 2021 May;76(3):353-359. |