InfectionNCT01623817
Effectiveness of Vancomycin Loading Therapy
A study testing Vancomycin HCL in people with Infection, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Infection
- What is being tested?
- Vancomycin HCL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
- Patients with SIRS (systemic inflammatory response syndrome)
- Intravenous vancomycin therapy deemed necessary
Who cannot join
- Age less than 20 years
- Age more than 75 years
- Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation
- History of adverse events to vancomycin 5. Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.
Read the detailed description
The Study drug
- Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus
Study design : Randomized controlled trials
Study Drug Administration
- If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.
- Conditions
- Infection
- Being tested
- Vancomycin HCL
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin HCLDrug
Also called The brand name is the Vancomycin hydrochloride., It is made by Lilly.
Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours.
Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Vancomcyin, maintain dose | No intervention | This arm is received only maintain dose of vancomycin (15mg/kg twice a day or 1g twice a day). |
| Vancomycin loading | Experimental | This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care. Receives: Drug: Vancomycin HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L
Measured: Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses.
Secondary outcomes (1)
Adverse event rate in each arm, including nephrotoxicity and rash.
Measured: 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyong Ran Peck, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623817
- Sponsor's protocol ID
- 2011-09-067
- Status last verified
- Jun 2012
- First submitted
- 18 Jun 2012
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vancomycin Loading Therapy
- ClinicalTrials.gov ID
- NCT01623817
- Acronym / sponsor ID
- 2011-09-067
- Conditions
- Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jun 2012 (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 goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.
Detailed description
The Study drug
- Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus
Study design : Randomized controlled trials
Study Drug Administration
- If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomcyin, maintain dose | No intervention | –This arm is received only maintain dose of vancomycin (15mg/kg twice a day or 1g twice a day). |
| Vancomycin loading | Experimental | Drug: Vancomycin HCLThis group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
- Patients with SIRS (systemic inflammatory response syndrome)
- Intravenous vancomycin therapy deemed necessary
Key exclusion criteria (4 listed)
- Age less than 20 years
- Age more than 75 years
- Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation
- History of adverse events to vancomycin 5. Pregnant woman
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 |
|---|---|---|
| Vancomycin HCLAlso: The brand name is the Vancomycin hydrochloride., It is made by Lilly.Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours. Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day. | Drug | Vancomycin loading |
Primary outcome
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L
Time frame: Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses.
1 secondary outcome
Adverse event rate in each arm, including nephrotoxicity and rash.
Time frame: 7 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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.
Kyong Ran Peck, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin HCL in people with Infection, run by Samsung Medical Center at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 12 Aug 2020. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L (time frame: Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses.). 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 12 Aug 2020.