Arbitrary Restriction Polymorphism 1NCT02134665
Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
An observational study of Arbitrary Restriction Polymorphism 1, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arbitrary Restriction Polymorphism 1
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2014
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who used vancomycin and who had diagnosed as severe acute pancreatitis (SAP group), and patients who had diagnosed as pneumonia (pneumonia group) . meanwhile, the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration.
Who may be able to join
- age 18-85years old
- vancomycin use ≥ 3days
Who cannot join
- age <18years old or >85 years old
- vancomycin use < 3days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
He, 86-21-64370045 ext. 662618
About this study
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
Read the detailed description
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
After reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between January 2010 and December 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (SAP group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. The fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. Using these measurements, we calculated the pharmacokinetic parameters using the Bayesian estimator.
- Conditions
- Arbitrary Restriction Polymorphism 1
- Keywords
- Vancomycin, severe acute pancreatitis, Creatinine clearance
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe acute pancreatitis | patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as severe acute pancreatitis. | |
| Pneumonia | patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as pneumonia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured
vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).
Measured: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (1)
the pharmacokinetic parameters was calculated using the Bayesian estimator.
Measured: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbitrary Restriction Polymorphism 1Studies of the same condition, open and under way.
- More trials run by Ruijin 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Juan, Ruijin Hospital
- Investigators
- Wan-Hua Yang, Prof., Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134665
- Sponsor's protocol ID
- hejuanwin19811119
- Status last verified
- May 2014
- First submitted
- 24 Jan 2014
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
- ClinicalTrials.gov ID
- NCT02134665
- Acronym / sponsor ID
- hejuanwin19811119
- Conditions
- Arbitrary Restriction Polymorphism 1
- Keywords
- Vancomycin, severe acute pancreatitis, Creatinine clearance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 9 May 2014 (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.
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
Detailed description
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
After reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between January 2010 and December 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (SAP group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. The fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. Using these measurements, we calculated the pharmacokinetic parameters using the Bayesian estimator.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severe acute pancreatitis | – | –patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as severe acute pancreatitis. |
| Pneumonia | – | –patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as pneumonia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who used vancomycin and who had diagnosed as severe acute pancreatitis (SAP group), and patients who had diagnosed as pneumonia (pneumonia group) . meanwhile, the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration.
Key inclusion criteria (2 listed)
- age 18-85years old
- vancomycin use ≥ 3days
Key exclusion criteria (2 listed)
- age <18years old or >85 years old
- vancomycin use < 3days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured
Time frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).
1 secondary outcome
the pharmacokinetic parameters was calculated using the Bayesian estimator.
Time frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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.
Wan-Hua Yang, Prof. study director
Ruijin 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 Arbitrary Restriction Polymorphism 1, run by Ruijin 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 2 inclusion and 2 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 9 May 2014. 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 Juan He (86-21-64370045 ext. 664405, hejuanwin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured (time frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2014.