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Research Title: Efficacy and Safety of Point- Of-care Procalcitonin Test to Reduce Antibiotic Exposure in VAP
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ventilator Associated Pneumonia | Diagnostic Test: PCT-guided group | Not Applicable |
Pneumonia remains one of the major cause of morbidity and mortality in critically ill patients in the intensive care unit (ICU) worldwide. In Malaysia, according to the Malaysian Registry of Intensive Care 2016, pneumonia was among the four (5.7%) most common diagnosis leading to admission to ICU. In many scenario, pneumonia associated with severe sepsis either as single source of sepsis or in combination with other source of infection which carry mortality mortality reported 53.4% 1. Timely, appropriate and adequate antibiotic therapy is of paramount importance in the critically ill patients with severe pneumonia. However, overly long antibiotic treatment is undesirable because of side effects, increasing antibiotic resistance2 and financial burden to patient and Malaysia Healthcare.
Antibiotic remain the main weapon to combat pneumonia. Nevertheless, rampant use of antibiotic without specific indicator is vain. Hence, with the latest technology, physicians not only rely on clinical improvement but also specific biomarkers for resolution of sepsis which might assist the ICU physicians in making decisions on antibiotic therapy on an individual basis.
Commonest used biomarkers for this purpose include leucocyte count and C-reactive protein (CRP). These biomarkers are sensitive but not specific. Procalcitonin (PCT) however has been advocated as a biomarker with a better specificity and sensitivity for diagnosis and follow-up of severe bacterial infections.
PCT is the prohormone of calcitonin. It consists of about 116 amino-acids. The locus of formation in classical pathway is the C-cells of the thyroid. In case of bacterial infection, PCT is formed in all tissues via an alternative pathway. Linscheid et al. 2004 described, in case of bacterial infection two mechanisms of synthesis are at work. At first cytokine-stimulated adherent monocytes release PCT in low quantities. This synthesis is limited. But it plays an important role in the initiation of PCT synthesis in storage tissues of humans. This PCT burst is initiated in all storage tissues (>18h). PCT is a perfect tool to differentiate between viral and bacterial infections (e.g. Gendrel et al. 1999). This is why in septic patients extremely high concentrations of PCT were found in the plasma (about 100,000-fold of the physiological concentration in healthy subjects).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Diagnostic |
| Official Title: | Research Title: Efficacy and Safety of Point- Of-care Procalcitonin Test to Reduce Antibiotic Exposure in Ventilator Associated Pneumonia (VAP) Patient in ICU: A Randomised Controlled Trial |
| Actual Study Start Date : | June 15, 2019 |
| Actual Primary Completion Date : | July 1, 2020 |
| Actual Study Completion Date : | July 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: PCT group
For patients randomly assigned to the PCT-guided group, measurements of serum PCT concentrations (Day 1, 3, 7, and 9) will be taken and made available to the attending physicians. This means 3 ml of whole blood will be sampled from the arterial line of the patients for each measurement the serum PCT in plain tubes. The samples will be immediately assayed for the PCT measurement using the available device and the results will be ready in next 30 minutes after running the system.
|
Diagnostic Test: PCT-guided group
In the PCT-guided group, the study protocol encourages to stop the prescribed antibiotics if PCT concentration decrease by 80% or more of its peak value (or if PCT concentration is ≥0·25 and <0·5 μg/L), and strongly encourage to stop the prescribed antibiotics when it reaches a value of < 0·25 μg/L. The attending physician is free to decide whether to continue antibiotic treatment in patients who reach these thresholds. Reasons for non-adherence will be recorded. Antibiotics in the standard-of-care group will be stopped according to local or national guidelines and according to the discretion of attending physicians. Patients will be followed-up until hospital discharge.
|
| No Intervention: Standard-of-care group |
- To compare the duration of antibiotic treatment between PCT and standard of care groups [ Time Frame: 3 to 14 days ]Most of the antiobiotic duration is about 5 - 14 days. In Ventilated Associated Pneumonia, the duration of antibiotic treatment is difficult to stop since the patient stil in intensive care unit due to multiple factors. Therefore the use of PCT guided might be useful.
- To compare the mortality between PCT and standard of care [ Time Frame: 30 days ]Malaysia Sepsis Mortality rate is nearly 50%. This could be because of higher APACHE score. In PCT guided group, the antibiotic might be stop earlier if clinically indicated. Therefore, the rate of patient die in this group is very important to assess the safety of using this point of care PCT in ICU.
- To compare the rate of recurrence infection between PCT and standard of care [ Time Frame: 30 days ]By stopping antibiotics earlier, the is possibility risk of recurrent infection if the source of infection is not adequately treated. Therefore the number of recurrence infection is required in PCT group to assess the safety of using PCT guided antibiotic in ICU
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years and above; and
- Admitted to the ICU; and
- Receive their first dose of antibiotics no longer than 24 h before inclusion to the trial for an assumed or proven bacterial infection.
- Treated as Ventilator Associated Pneumonia (VAP)
Exclusion Criteria:
- Systemic antibiotics as prophylaxis only
- Antibiotics solely as part of selective decontamination of the digestive tract
- Prolonged therapy (eg, endocarditis)
- Expected ICU stay of less than 24 h
- Severe immunosuppression
- Severe infections due to non-bacterial causes
- Previously been enrolled in the study
| Malaysia | |
| Mohd Zulfakar Mazlan, MBBS | |
| Kota Bharu, Kelantan, Malaysia, 16150 | |
| Mohd Zulfakar Mazlan | |
| Kota Bharu, Kelantan, Malaysia, 16150 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 8, 2019 | ||||
| First Posted Date ICMJE | June 11, 2019 | ||||
| Last Update Posted Date | July 15, 2020 | ||||
| Actual Study Start Date ICMJE | June 15, 2019 | ||||
| Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare the duration of antibiotic treatment between PCT and standard of care groups [ Time Frame: 3 to 14 days ] Most of the antiobiotic duration is about 5 - 14 days. In Ventilated Associated Pneumonia, the duration of antibiotic treatment is difficult to stop since the patient stil in intensive care unit due to multiple factors. Therefore the use of PCT guided might be useful.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Research Title: Efficacy and Safety of Point- Of-care Procalcitonin Test to Reduce Antibiotic Exposure in VAP | ||||
| Official Title ICMJE | Research Title: Efficacy and Safety of Point- Of-care Procalcitonin Test to Reduce Antibiotic Exposure in Ventilator Associated Pneumonia (VAP) Patient in ICU: A Randomised Controlled Trial | ||||
| Brief Summary | Several studies have shown that PCT guidance can reduce the duration of antibiotic treatment for patients with bacterial infections in the ICU, without compromising the safety outcomes. However PCT is known to be more costly than standard biomarkers that commonly use in our ICU setup. This remain the main challenge for us whether by monitoring the PCT level, it can reduce both the duration of antibiotic simultaneously reduce the total cost of the treatment for the patients. A local study addressing efficacy, safety and cost analysis of PCT-guided antibiotic therapy in severe pneumonia patients is therefore warranted. Until the results from a local study become available, the utility of PCT to guide antibiotic duration in our patient population cannot be recommended. | ||||
| Detailed Description |
Pneumonia remains one of the major cause of morbidity and mortality in critically ill patients in the intensive care unit (ICU) worldwide. In Malaysia, according to the Malaysian Registry of Intensive Care 2016, pneumonia was among the four (5.7%) most common diagnosis leading to admission to ICU. In many scenario, pneumonia associated with severe sepsis either as single source of sepsis or in combination with other source of infection which carry mortality mortality reported 53.4% 1. Timely, appropriate and adequate antibiotic therapy is of paramount importance in the critically ill patients with severe pneumonia. However, overly long antibiotic treatment is undesirable because of side effects, increasing antibiotic resistance2 and financial burden to patient and Malaysia Healthcare. Antibiotic remain the main weapon to combat pneumonia. Nevertheless, rampant use of antibiotic without specific indicator is vain. Hence, with the latest technology, physicians not only rely on clinical improvement but also specific biomarkers for resolution of sepsis which might assist the ICU physicians in making decisions on antibiotic therapy on an individual basis. Commonest used biomarkers for this purpose include leucocyte count and C-reactive protein (CRP). These biomarkers are sensitive but not specific. Procalcitonin (PCT) however has been advocated as a biomarker with a better specificity and sensitivity for diagnosis and follow-up of severe bacterial infections. PCT is the prohormone of calcitonin. It consists of about 116 amino-acids. The locus of formation in classical pathway is the C-cells of the thyroid. In case of bacterial infection, PCT is formed in all tissues via an alternative pathway. Linscheid et al. 2004 described, in case of bacterial infection two mechanisms of synthesis are at work. At first cytokine-stimulated adherent monocytes release PCT in low quantities. This synthesis is limited. But it plays an important role in the initiation of PCT synthesis in storage tissues of humans. This PCT burst is initiated in all storage tissues (>18h). PCT is a perfect tool to differentiate between viral and bacterial infections (e.g. Gendrel et al. 1999). This is why in septic patients extremely high concentrations of PCT were found in the plasma (about 100,000-fold of the physiological concentration in healthy subjects). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Diagnostic |
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| Condition ICMJE | Ventilator Associated Pneumonia | ||||
| Intervention ICMJE | Diagnostic Test: PCT-guided group
In the PCT-guided group, the study protocol encourages to stop the prescribed antibiotics if PCT concentration decrease by 80% or more of its peak value (or if PCT concentration is ≥0·25 and <0·5 μg/L), and strongly encourage to stop the prescribed antibiotics when it reaches a value of < 0·25 μg/L. The attending physician is free to decide whether to continue antibiotic treatment in patients who reach these thresholds. Reasons for non-adherence will be recorded. Antibiotics in the standard-of-care group will be stopped according to local or national guidelines and according to the discretion of attending physicians. Patients will be followed-up until hospital discharge.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | July 1, 2020 | ||||
| Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Malaysia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03982667 | ||||
| Other Study ID Numbers ICMJE | USMalaysia | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia | ||||
| Study Sponsor ICMJE | Mohd Zulfakar Mazlan, MBBS | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Universiti Sains Malaysia | ||||
| Verification Date | July 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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