Infection, BacterialNCT04297176
Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods
A study testing Vancomycin-traditional dosing and Vancomycin- Trough-only based dosing in people with Infection, Bacterial, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Vancomycin-traditional dosing and Vancomycin- Trough-only based dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteQatar
- Study dates
- 23 Jan 2020to 2 Jul 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults at least 18 yrs who are hospitalized and initiated on IV vancomycin
Who cannot join
- renal instability
- immunosuppression;
- vancomycin allergy;
- history of recurrent peritonitis
- administration of < 4 doses of vancomycin
- pregnancy;
- hemoglobin < 8 g/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches.
Research questions: Which vancomycin therapeutic drug monitoring (TDM) approach is associated with superior economic outcomes?
-Objectives: In this proposed multicenter randomized controlled trial (RCT), we aim to compare the pharmacoeconomic outcomes of various vancomycin TDM approaches.
- Conditions
- Infection, Bacterial
- Being tested
- Vancomycin-traditional dosing, Vancomycin- Trough-only based dosing
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin-traditional dosingDrug
The dose is calculated based on 2 vancomycin serum levels
Vancomycin- Trough-only based dosingDrug
The dose is calculated based on 1 vancomycin serum level (i.e. trough)
| Study group | Role | What they receive |
|---|---|---|
| Traditional monitoring method | Experimental | Patients are dosed using two timed vancomycin serum concentrations Receives: Drug: Vancomycin-traditional dosing |
| One concentration method | Active comparator | Patients are dosed based on one timed vancomycin serum level Receives: Drug: Vancomycin- Trough-only based dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic success
Therapeutic success will be assessed as therapeutic cure (composite endpoint)or therapeutic failure (composite endpoint). Therapeutic cure is defined as clinical cure and/or microbiologic cure . Clinical cure is defined as the absence of infection signs/symptoms without the need for additional antibiotic treatment. Microbiologic cure is defined as negative blood cultures at 5 days after vancomycin treatment initiation. Therapeutic failure includes at least one of the following -clinical failure, microbiologic failure, premature discontinuation due to ADR or all-cause mortality. Clinical failure is defined as insufficient clinical response to initial vancomycin therapy necessitating antibiotic change. Microbiological failure is defined as a positive culture at ≥ 5 days after initiation of vancomycin treatment.
Measured: The follow up time varies according to the infection type. It ranges from 7 days to 1 month.
cost-benefit
The hospital and treatment related costs will be compared between the two study arms, from a hospital perspective, associating the clinical outcomes mentioned in Outcome 1 above. The arm showing least costs will be determined as more beneficial to the healthcare system.
Measured: Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start23 Jan 2020
- Primary completion4 May 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qatar University
- Responsible party
- Principal investigator, Dr. Eman Zeyad Ibrahim Elmekaty, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297176
- Sponsor's protocol ID
- 15418/15
- Status last verified
- Aug 2022
- First submitted
- 2 Mar 2020
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
- ClinicalTrials.gov ID
- NCT04297176
- Acronym / sponsor ID
- 15418/15
- Conditions
- Infection, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Qatar University
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 5 Mar 2020 (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.
Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches.
Research questions: Which vancomycin therapeutic drug monitoring (TDM) approach is associated with superior economic outcomes?
-Objectives: In this proposed multicenter randomized controlled trial (RCT), we aim to compare the pharmacoeconomic outcomes of various vancomycin TDM approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional monitoring method | Experimental | Drug: Vancomycin-traditional dosingPatients are dosed using two timed vancomycin serum concentrations |
| One concentration method | Active comparator | Drug: Vancomycin- Trough-only based dosingPatients are dosed based on one timed vancomycin serum level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults at least 18 yrs who are hospitalized and initiated on IV vancomycin
Key exclusion criteria (7 listed)
- renal instability
- immunosuppression;
- vancomycin allergy;
- history of recurrent peritonitis
- administration of < 4 doses of vancomycin
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-traditional dosingThe dose is calculated based on 2 vancomycin serum levels | Drug | Traditional monitoring method |
| Vancomycin- Trough-only based dosingThe dose is calculated based on 1 vancomycin serum level (i.e. trough) | Drug | One concentration method |
Primary outcome
therapeutic success
Time frame: The follow up time varies according to the infection type. It ranges from 7 days to 1 month.
Therapeutic success will be assessed as therapeutic cure (composite endpoint)or therapeutic failure (composite endpoint). Therapeutic cure is defined as clinical cure and/or microbiologic cure . Clinical cure is defined as the absence of infection signs/symptoms without the need for additional antibiotic treatment. Microbiologic cure is defined as negative blood cultures at 5 days after vancomycin treatment initiation. Therapeutic failure includes at least one of the following -clinical failure, microbiologic failure, premature discontinuation due to ADR or all-cause mortality. Clinical failure is defined as insufficient clinical response to initial vancomycin therapy necessitating antibiotic change. Microbiological failure is defined as a positive culture at ≥ 5 days after initiation of vancomycin treatment.
cost-benefit
Time frame: Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs
The hospital and treatment related costs will be compared between the two study arms, from a hospital perspective, associating the clinical outcomes mentioned in Outcome 1 above. The arm showing least costs will be determined as more beneficial to the healthcare system.
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 15 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-traditional dosing and Vancomycin- Trough-only based dosing in people with Infection, Bacterial, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 inclusion and 7 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 15 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 Qatar. 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?
therapeutic success (time frame: The follow up time varies according to the infection type. It ranges from 7 days to 1 month.). The study lists 2 primary outcomes in all. 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 15 Aug 2022.