Usage of Procalcitonin to Reduce Antibiotics Duration in VAP in Neurosurgical ICU

NCT06395454 | Not Yet Recruiting

• 1 other identifier: USM/JEPeM/KK/24010018
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia

Conditions

Antibiotic Side Effect

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• To compare 14 days mortality rate in between 2 arms

  14 days

• To compare proportion of difficult to treat organisms (MRO) in between 2 arms

  14 days

• To compare the proportion of reinfection within 72 hours after stopping antibiotics

  14 days

Study Arms (2)

Procalcitonin guided antibiotics treatment duration

EXPERIMENTAL

Procalcitonin test in addition to standard care blood investigations

Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levels

Standard care guided antibiotics treatment duration

NO INTERVENTION

Interventions

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.

Procalcitonin guided antibiotics treatment duration

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adults more than 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to Neuro-ICU \& Trauma ICU
• Patients aged \>18 years old.
• Ventilation for \>48 hours
• Patient with arterial line or central line

You may not qualify if:

• Patients who are on antibiotics but not assumed or proven to have VAP
• Expected short ICU stay (\<3 Days)
• Non-bacterial infections
• Long term antibiotic treatment (transplant or chemotherapy patients, endocarditis, osteomyelitis)
• Hospitalisation 48hours before enrolment
• Severe immunosuppression
• Pregnancy
• Primary team's decision to continue antibiotics for 14 days prior to trial
• DNAR or expected to die within 5 days

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Related Publications (17)

• 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.

  PMID: 29982303 BACKGROUND

• 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.

  PMID: 32157357 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.

  PMID: 28480245 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.

  PMID: 18470710 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.

  PMID: 19034493 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.

  PMID: 34006044 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.

  PMID: 20097417 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.

  PMID: 34177168 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.

  PMID: 26553084 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.

  PMID: 16603606 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.

  PMID: 23418298 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.

  PMID: 19493352 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.

  PMID: 19529989 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.

  PMID: 29271844 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.

  PMID: 21398306 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.

  PMID: 38456106 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.

  PMID: 34031334 BACKGROUND

Study Officials

• Zulfakar Mazlan

  Associated Professor Dr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerome Loh

CONTACT

+60128589099; jeromederyang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share