Critically IllVCMTDMinCINCT02896218
Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry
An observational study of Critically Ill, run by Peking University Third Hospital at 1 site in China.
Trial summary
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critically Ill
- What is being tested?
- Pharmacists consultation
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The prospective cohort: all patients in this cohort will receive pharmacist consultation when prescribed vancomycin. The retrospective cohort: patients in this cohort received usual care from JAN 2010 to MAR 2015; patients in this cohort received pharmacist consultation from APR 2016 to JUL 2016.
Who may be able to join
- Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010.
- Receiving vancomycin therapy for 72 hours or more.
- Aged ≥ 18 years.
Who cannot join
- Administration of vancomycin in non-intravenous access.
- Life expectancy of less than 24 hours.
- Pregnancy women.
- Presence of immunodeficiency.
- Presence of hematological disorder.
- Written informed consent not obtained in the prospective cohort.
Trial locations and contacts
1 site in 1 country.
Qinggang Ge, M.D. contact
Yingying YAN, Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Qinggang Ge, M.D., qingganggelin@126.com
Yingying Yan, Ph.D., yanyingying89@163.com
About this study
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
Read the detailed description
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.
- Conditions
- Critically Ill
- Being tested
- Pharmacists consultation
- Keywords
- Vancomycin, Critically Ill, Pharmacist, Population Pharmacokinetic, Bayesian Methods
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacists consultationOther
Pharmacists consultation of vancomycin individualized dosing strategy
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist consulting group | When physicians make the decision that patients need to prescribe vancomycin or need dose adjustment, they will call for a pharmacist consultation. Pharmacists will provide the initial regimen based on PPK methods if applicable, otherwise give the suggestion of the initial dosage according to guidelines. Also, pharmacists will give suggestions on the time of sampling for serum concentration measurement. For dosage adjustment, pharmacists will be informed the results of serum vancomycin concentration, and then make a calculation using Bayesian estimation to determine whether there is a necessity to change the dosing regimen. Pharmacists will follow the patients until they discharge. Receives: Other: Pharmacists consultation | |
| Usual care group | Empirical use of vancomycin without pharmacists consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of treatment failure
Measured: 2016-9 to 2018-1
Secondary outcomes (8)
All cause mortality
Measured: 2016-9 to 2018-1
Mortality caused by infections
Measured: 2016-9 to 2018-1
Mortality caused by gram-positive infections
Measured: 2016-9 to 2018-1
Adverse events related to vancomycin
Measured: 2016-9 to 2018-1
Nephrotoxicity related to vancomycin
According to KDIGO, AKI is defined by any of the following:
- Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours; or
- Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days; or
- Urine volume <0.5 mL/kg/h for six hours.
All adverse events will be assessed and analyzed with WHO-UMC causality criteria by investigators. Adverse events related to vancomycin, especially nephrotoxicity, will be analyzed.
Measured: 2016-9 to 2018-1
Cost-effectiveness of pharmacist intervention
The outcome is the incremental cost of preventing one treatment failure infection-related mortality or nephrotoxicity.
Measured: 2016-9 to 2018-1
Duration of using ventilator
Measured: 2016-9 to 2018-1
Vancomycin dosage
Measured: -2016-9 to 201
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinggang GE, Peking University Third Hospital
- Investigators
- Qinggang Ge, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896218
- Sponsor's protocol ID
- CM-001
- Acronym
- VCMTDMinCI
- Status last verified
- May 2019
- First submitted
- 17 Aug 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC Jr, Craig WA, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adults summary of consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2009 Nov;29(11):1275-9. doi: 10.1592/phco.29.11.1275.
PubMed 19873687Ye ZK, Chen YL, Chen K, Zhang XL, Du GH, He B, Li DK, Liu YN, Yang KH, Zhang YY, Zhai SD; Guideline Steering Group, the Guideline Development Group and the Guideline Secretary Group. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother. 2016 Nov;71(11):3020-3025. doi: 10.1093/jac/dkw254. Epub 2016 Jul 11.
PubMed 27494905Matsumoto K, Takesue Y, Ohmagari N, Mochizuki T, Mikamo H, Seki M, Takakura S, Tokimatsu I, Takahashi Y, Kasahara K, Okada K, Igarashi M, Kobayashi M, Hamada Y, Kimura M, Nishi Y, Tanigawara Y, Kimura T. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013 Jun;19(3):365-80. doi: 10.1007/s10156-013-0599-4. Epub 2013 May 15. No abstract available.
PubMed 23673472Pea F, Bertolissi M, Di Silvestre A, Poz D, Giordano F, Furlanut M. TDM coupled with Bayesian forecasting should be considered an invaluable tool for optimizing vancomycin daily exposure in unstable critically ill patients. Int J Antimicrob Agents. 2002 Nov;20(5):326-32. doi: 10.1016/s0924-8579(02)00188-7.
PubMed 12431867Smith C, Burley C, Ireson M, Johnson T, Jordan D, Knight S, Mason T, Massey D, Moss J, Williams K. Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party. J Antimicrob Chemother. 1998 Apr;41(4):467-80. doi: 10.1093/jac/41.4.467.
PubMed 9598778
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry
- ClinicalTrials.gov ID
- NCT02896218
- Acronym / sponsor ID
- VCMTDMinCI / CM-001
- Conditions
- Critically Ill
- Keywords
- Vancomycin, Critically Ill, Pharmacist, Population Pharmacokinetic, Bayesian Methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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.
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
Detailed description
Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.
This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist consulting group | – | Other: Pharmacists consultationWhen physicians make the decision that patients need to prescribe vancomycin or need dose adjustment, they will call for a pharmacist consultation. Pharmacists will provide the initial regimen based on PPK methods if applicable, otherwise give the suggestion of the initial dosage according to guidelines. Also, pharmacists will give suggestions on the time of sampling for serum concentration measurement. For dosage adjustment, pharmacists will be informed the results of serum vancomycin concentration, and then make a calculation using Bayesian estimation to determine whether there is a necessity to change the dosing regimen. Pharmacists will follow the patients until they discharge. |
| Usual care group | – | –Empirical use of vancomycin without pharmacists consultation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The prospective cohort: all patients in this cohort will receive pharmacist consultation when prescribed vancomycin. The retrospective cohort: patients in this cohort received usual care from JAN 2010 to MAR 2015; patients in this cohort received pharmacist consultation from APR 2016 to JUL 2016.
Key inclusion criteria (3 listed)
- Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN 2010.
- Receiving vancomycin therapy for 72 hours or more.
- Aged ≥ 18 years.
Key exclusion criteria (6 listed)
- Administration of vancomycin in non-intravenous access.
- Life expectancy of less than 24 hours.
- Pregnancy women.
- Presence of immunodeficiency.
- Presence of hematological disorder.
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 |
|---|---|---|
| Pharmacists consultationPharmacists consultation of vancomycin individualized dosing strategy | Other | Pharmacist consulting group |
Primary outcome
The rate of treatment failure
Time frame: 2016-9 to 2018-1
8 secondary outcomes
All cause mortality
Time frame: 2016-9 to 2018-1
Mortality caused by infections
Time frame: 2016-9 to 2018-1
Mortality caused by gram-positive infections
Time frame: 2016-9 to 2018-1
Adverse events related to vancomycin
Time frame: 2016-9 to 2018-1
Nephrotoxicity related to vancomycin
Time frame: 2016-9 to 2018-1
Cost-effectiveness of pharmacist intervention
Time frame: 2016-9 to 2018-1
Duration of using ventilator
Time frame: 2016-9 to 2018-1
Vancomycin dosage
Time frame: -2016-9 to 201
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 19873687Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC Jr, Craig WA, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adults summary of consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2009 Nov;29(11):1275-9. doi: 10.1592/phco.29.11.1275.
- Background: PubMed 27494905Ye ZK, Chen YL, Chen K, Zhang XL, Du GH, He B, Li DK, Liu YN, Yang KH, Zhang YY, Zhai SD; Guideline Steering Group, the Guideline Development Group and the Guideline Secretary Group. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother. 2016 Nov;71(11):3020-3025. doi: 10.1093/jac/dkw254. Epub 2016 Jul 11.
- Background: PubMed 23673472Matsumoto K, Takesue Y, Ohmagari N, Mochizuki T, Mikamo H, Seki M, Takakura S, Tokimatsu I, Takahashi Y, Kasahara K, Okada K, Igarashi M, Kobayashi M, Hamada Y, Kimura M, Nishi Y, Tanigawara Y, Kimura T. Practice guidelines for therapeutic drug monitoring of vancomycin: a consensus review of the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring. J Infect Chemother. 2013 Jun;19(3):365-80. doi: 10.1007/s10156-013-0599-4. Epub 2013 May 15. No abstract available.
- Background: PubMed 12431867Pea F, Bertolissi M, Di Silvestre A, Poz D, Giordano F, Furlanut M. TDM coupled with Bayesian forecasting should be considered an invaluable tool for optimizing vancomycin daily exposure in unstable critically ill patients. Int J Antimicrob Agents. 2002 Nov;20(5):326-32. doi: 10.1016/s0924-8579(02)00188-7.
- Background: PubMed 9598778Smith C, Burley C, Ireson M, Johnson T, Jordan D, Knight S, Mason T, Massey D, Moss J, Williams K. Clinical trials of antibacterial agents: a practical guide to design and analysis. Statisticians in the Pharmaceutical Industry Working Party. J Antimicrob Chemother. 1998 Apr;41(4):467-80. doi: 10.1093/jac/41.4.467.
- 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.
Qinggang Ge, M.D. contact
Yingying YAN, Ph.D. contact
Qinggang Ge, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 6 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Qinggang Ge, M.D. (qingganggelin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of treatment failure (time frame: 2016-9 to 2018-1). 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 NCT02896218, which also lists 5 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 29 May 2019.