TerminatedPhase 4

Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Stopped: The study was closed due to slow enrollment.

United States8 participantsStarted 2021-03-03

Plain-language summary

Evaluate the safety and outcomes associated between the two treatment modalities

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Nephrotoxicity in Subjects

Timeframe: week 8

Trial details

NCT IDNCT04648696

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-31

Results submitted2023-11-30

View on ClinicalTrials.gov More Infection trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.