Antibiotic Side EffectNCT06395454
Usage of Procalcitonin to Reduce Antibiotics Duration in VAP in Neurosurgical ICU
A study testing Shorten antibiotics duration based on procalcitonin test levels in people with Antibiotic Side Effect, run by Universiti Sains Malaysia.
Trial summary
Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Side Effect
- What is being tested?
- Shorten antibiotics duration based on procalcitonin test levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to Neuro-ICU \& Trauma ICU
- Patients aged >18 years old.
- Ventilation for >48 hours
- VAP and treated with antibiotics <24hours prior to inclusion in trial.
- Patient with arterial line or central line
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Primary team's decision to continue antibiotics for 14 days prior to trial
- DNAR or expected to die within 5 days
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Procalcitonin as a Sepsis Biomarker in Guiding Antibiotics Treatment Duration in Ventilator Associated Pneumonia in Neuro-ICU: A Randomised Controlled Trial
Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia
Read the detailed description
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.
- Conditions
- Antibiotic Side Effect
- Being tested
- Shorten antibiotics duration based on procalcitonin test levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorten antibiotics duration based on procalcitonin test levelsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin guided antibiotics treatment duration | Experimental | Procalcitonin test in addition to standard care blood investigations Receives: Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levels |
| Standard care guided antibiotics treatment duration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
compare the duration of antibiotics between 2 arms
Measured: 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
Measured: 14 days
Secondary outcomes (3)
To compare 14 days mortality rate in between 2 arms
compare 14 days mortality rate in between 2 arms
Measured: 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
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia
- Investigators
- Zulfakar Mazlan, Principal investigator, Associated Professor Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395454
- Sponsor's protocol ID
- USM/JEPeM/KK/24010018
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29982303Papazian 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.
PubMed 32157357Rhee 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.
PubMed 28480245Brunkhorst 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.
PubMed 18470710Schroeder 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.
PubMed 19034493Z 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.
PubMed 34006044Bouadma 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.
PubMed 20097417Vishalashi 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.
PubMed 34177168Najafi 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.
PubMed 26553084Christ-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.
PubMed 16603606Annane 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.
PubMed 23418298Hochreiter 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.
PubMed 19493352Schuetz 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.
PubMed 19529989Iankova 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.
PubMed 29271844Kibe 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.
PubMed 21398306
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin as a Sepsis Biomarker in Guiding Antibiotics Treatment Duration in Ventilator Associated Pneumonia in Neuro-ICU: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06395454
- Acronym / sponsor ID
- USM/JEPeM/KK/24010018
- Conditions
- Antibiotic Side Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin guided antibiotics treatment duration | Experimental | Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levelsProcalcitonin test in addition to standard care blood investigations |
| Standard care guided antibiotics treatment duration | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to Neuro-ICU \& Trauma ICU
- Patients aged >18 years old.
- Ventilation for >48 hours
- VAP and treated with antibiotics <24hours prior to inclusion in trial.
- Patient with arterial line or central line
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shorten antibiotics duration based on procalcitonin test levelsprocalcitonin 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. | Diagnostic test | Procalcitonin guided antibiotics treatment duration |
Primary outcome
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
Time frame: 14 days
compare the duration of antibiotics between 2 arms
To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic
Time frame: 14 days
compare the length of ICU stay in between 2 arms
3 secondary outcomes
To compare 14 days mortality rate in between 2 arms
Time frame: 14 days
To compare proportion of difficult to treat organisms (MRO) in between 2 arms
Time frame: 14 days
To compare the proportion of reinfection within 72 hours after stopping antibiotics
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 29982303Bonell 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.
- Background: PubMed 32157357Papazian 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.
- Background: PubMed 28480245Rhee 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.
- Background: PubMed 18470710Brunkhorst 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.
- Background: PubMed 19034493Schroeder 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.
- Background: PubMed 34006044Z 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.
- Background: PubMed 20097417Bouadma 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.
- Background: PubMed 34177168Vishalashi 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.
- Background: PubMed 26553084Najafi 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.
- Background: PubMed 16603606Christ-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.
- Background: PubMed 23418298Annane 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.
- Background: PubMed 19493352Hochreiter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfakar Mazlan principal investigator
Associated Professor Dr
Questions about this trial
What is this clinical trial studying?
A study testing Shorten antibiotics duration based on procalcitonin test levels in people with Antibiotic Side Effect, run by Universiti Sains Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerome Loh (+60128589099, jeromederyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395454, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.