InfectionPhase 4NCT04648696
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
A Phase 4 study testing Vancomycin CI and Vancomycin II in people with Infection, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Evaluate the safety and outcomes associated between the two treatment modalities Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Vancomycin CI and Vancomycin II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 31 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients at least 18 years of age
- Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
- Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
- Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
- Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment
Who cannot join
- Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
- Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial
Evaluate the safety and outcomes associated between the two treatment modalities
Read the detailed description
Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
- Conditions
- Infection
- Being tested
- Vancomycin CI, Vancomycin II
- Keywords
- infusion therapy, continuous infusions, nephrotoxicity, outpatient parenteral antibiotic therapy, vancomycin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin CIDrug
Also called glycopeptide antibiotic
The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
Vancomycin IIDrug
Also called glycopeptide antibiotic
Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
| Study group | Role | What they receive |
|---|---|---|
| continuous infusions (CI) group | Active comparator | CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge Receives: Drug: Vancomycin CI |
| Intermittent infusion (II) group | Active comparator | Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge Receives: Drug: Vancomycin II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nephrotoxicity in Subjects
Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
Measured: week 8
Secondary outcomes (5)
Number of Leukopenia in Subjects
Number of Subjects with White Blood Cell (WBC) < 4,000 x 103 cells/µL
Measured: week 8
Number of Infusion-related Reactions
Flushing/Erythema /Rash/Red Man Syndrome
Measured: week 8
Number of Serum Vancomycin Measurements Within Therapeutic Range
Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL
Measured: week 8
Number of Participants With Resolutions of Symptoms Associated With the Infection
Number of Subjects without need for additional induction therapy beyond the planned end date
Measured: week 8
Number of Participants With Treatment Failures
Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection
Measured: week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start3 Mar 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: The study was closed due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionStudies 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
- Model description
- To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Williamson, PharmD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648696
- Sponsor's protocol ID
- IRB00069815
- Status last verified
- Sep 2022
- First submitted
- 23 Nov 2020
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT04648696
- Acronym / sponsor ID
- IRB00069815
- Conditions
- Infection
- Keywords
- infusion therapy, continuous infusions, nephrotoxicity, outpatient parenteral antibiotic therapy, vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to slow enrollment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and outcomes associated between the two treatment modalities
Detailed description
Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
| Arm | Type | Receives |
|---|---|---|
| continuous infusions (CI) group | Active comparator | Drug: Vancomycin CICI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge |
| Intermittent infusion (II) group | Active comparator | Drug: Vancomycin IIInpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients at least 18 years of age
- Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
- Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
- Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
- Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment
Key exclusion criteria (2 listed)
- Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
- Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL
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 CIAlso: glycopeptide antibioticThe CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin | Drug | continuous infusions (CI) group |
| Vancomycin IIAlso: glycopeptide antibioticStudy candidates that are randomized to the II group will continue their current intravenous dosing upon discharge | Drug | Intermittent infusion (II) group |
Primary outcome
Number of Nephrotoxicity in Subjects
Time frame: week 8
Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
5 secondary outcomes
Number of Leukopenia in Subjects
Time frame: week 8
Number of Infusion-related Reactions
Time frame: week 8
Number of Serum Vancomycin Measurements Within Therapeutic Range
Time frame: week 8
Number of Participants With Resolutions of Symptoms Associated With the Infection
Time frame: week 8
Number of Participants With Treatment Failures
Time frame: week 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John Williamson, PharmD principal investigator
Wake Forest Health Sciences
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 Vancomycin CI and Vancomycin II in people with Infection, run by Wake Forest University Health Sciences at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 14 Feb 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Nephrotoxicity in Subjects (time frame: week 8). 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 14 Feb 2024.