Pneumonia, StaphylococcalPhase 4NCT04088305
Vancomycin Dosage Strategy Based on a Trough Concentration Model
A Phase 4 study testing Individualized therapy in people with Pneumonia, Staphylococcal, run by Peking University Third Hospital at 1 site in China.
Trial summary
Study design: Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pneumonia, Staphylococcal
- What is being tested?
- Individualized therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 Jun 2022
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
- Sixty years and older.
Who cannot join
- younger than 60 years old
- Accepted blood purification therapy
- Pregnancy
- Positive HIV antibody titre
- Had known or suspected tuberculosis or other infections caused by fungi at baseline.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospita
Beijing, Beijing Municipality, 100191
About this study
Official title: Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
Study design:
Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.
Read the detailed description
This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.
- Conditions
- Pneumonia, Staphylococcal
- Being tested
- Individualized therapy
- Keywords
- pneumonia, vancomycin, trough concentration, elderly patients
- Medical subject headings
- Pneumonia, Staphylococcal, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized therapyDrug
Also called Vancomycin
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients of study group will accept vancomycin strategies decided by a serum trough concentration model. Receives: Drug: Individualized therapy |
| Control group | No intervention | Patients of control group will accept vancomycin dosages decided by attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of vancomycin therapeutic serum trough concentrations
The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group
Measured: before the fifth vancomycin dosage
Secondary outcomes (3)
Clinical success rate
the proportion of patients with clinical success
Measured: Seven days after vancomycin withdrawal.
Vancomycin doses
Vancomycin daily doses and totally doses
Measured: At the end of vancomycin therapy, an average of 10 days.
Incidence of acute kidney injury
The incidence of vancomycin-associated acute kidney injury
Measured: At the end of vancomycin treatment, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Oct 2019
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, StaphylococcalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingtao Zhou, Peking University Third Hospital
- Investigators
- Qingtao Zhou, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088305
- Sponsor's protocol ID
- Y75505-03
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
- ClinicalTrials.gov ID
- NCT04088305
- Acronym / sponsor ID
- Y75505-03
- Conditions
- Pneumonia, Staphylococcal
- Keywords
- pneumonia, vancomycin, trough concentration, elderly patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Sep 2019 (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.
Study design:
Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.
Detailed description
This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Individualized therapyPatients of study group will accept vancomycin strategies decided by a serum trough concentration model. |
| Control group | No intervention | –Patients of control group will accept vancomycin dosages decided by attending physician. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
- Sixty years and older.
Key exclusion criteria (5 listed)
- younger than 60 years old
- Accepted blood purification therapy
- Pregnancy
- Positive HIV antibody titre
- Had known or suspected tuberculosis or other infections caused by fungi at baseline.
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 |
|---|---|---|
| Individualized therapyAlso: VancomycinDosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician | Drug | Study group |
Primary outcome
The incidence of vancomycin therapeutic serum trough concentrations
Time frame: before the fifth vancomycin dosage
The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group
3 secondary outcomes
Clinical success rate
Time frame: Seven days after vancomycin withdrawal.
Vancomycin doses
Time frame: At the end of vancomycin therapy, an average of 10 days.
Incidence of acute kidney injury
Time frame: At the end of vancomycin treatment, an average of 10 days.
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 31 Aug 2022.
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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.
Qingtao Zhou, Dr. 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?
A Phase 4 study testing Individualized therapy in people with Pneumonia, Staphylococcal, 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 2 inclusion and 5 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 31 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of vancomycin therapeutic serum trough concentrations (time frame: before the fifth vancomycin dosage). 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 31 Aug 2022.