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Lipoglycopeptide Antibiotic

Dalbavancin for Staphylococcus Aureus Bacteremia

Q: Does this research study admit seniors for participation?

This trial is open to individuals aged between 18 and 99. Additionally, there are 18 studies for minors and 84 trials specifically designed for seniors above 65 years old.

Q: Is recruitment for this investigation currently open?

Affirmative. According to the clinicaltrials.gov database, this research endeavour is actively searching for individuals that fulfill its criteria. This experiment was first published on April 22nd 2021 and recently revised on November 10th 2022; 200 patients are needed from 30 distinct sites.

Q: How many distinct sites are participating in this investigation?

Patients are currently being recruited for this clinical trial out of 30 sites, with the most proximate ones located in Rockville, Tampa and Boston. To reduce journey requirements, it is recommended that participants select a clinic near to them when enrolling.

Q: Is it possible for me to become involved in this medical research experiment?

For this medical trial, 200 individuals with bacteremia aged between 18 and 99 are eligible for enrollment. A few key requirements include obtaining written consent from the patient or their legal representative; receiving effective antibiotic therapy for at least three days (maximum 10); having no growth on blood cultures incubated for 48 hours; being willing to receive dalbavancin in two doses or standard of care intravenous monotherapy over 4-8 weeks from randomization; returning to the hospital/designated clinic as necessary; and finally, having a prognosis that suggests survival is possible when receiving <a href="https://www.withpower.com/clinical-trials/antibiotics">antibiotics</a> and supportive care throughout the study.

Q: To what extent is Dalbavancin a safe and effective treatment for patients?

Our analysts at Power rated the safety of Dalbavancin as a 2, since this is currently in Phase 2 trials, making it safe to use but having no demonstrable efficacy data.

Q: What health conditions can Dalbavancin be employed to address?

Dalbavancin is a viable option for treating staphylococcal infections and other bacterial issues like bacteremia, catheter-related contagions, and more.

Q: What former research has been carried out concerning Dalbavancin?

Dalbavancin was initially studied in 2010 at Sacramento Pediatric Gastroenterology and has since seen 239 studies reach their conclusion. Currently, 73 trials are active, with a considerable amount of them taking place out of Rockville, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Q: What is the scale of this research endeavor in terms of participants?

Affirmative. According to clinicaltrials.gov, this investigation began on April 22nd 2021 and is still actively seeking patients with the most recent update being November 10th 2022. 200 volunteers are needed from 30 different locations in total.

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 180

Awards & highlights

Study Summary

This trial is testing whether the antibiotic dalbavancin is better than a standard antibiotic regimen at treating bacteremia or right-sided native valve infective endocarditis caused by S. aureus. 200 subjects will be randomly assigned to receive either dalbavancin or the standard antibiotic regimen, and the primary objective is to compare the two treatments at Day 70.

Eligible Conditions

Staph Bacteraemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Desirability of Outcome Ranking (DOOR) for the treatment of subjects with complicated Staphylococcus aureus bacteremia

Secondary outcome measures

Incidence of all-cause mortality

Proportion of participants who experienced a clinical efficacy of antibiotic therapy

Proportion of participants who experienced any adverse event (AE) leading to study drug discontinuation

+3 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT03233438

Hypoglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Usual Care

New Critical Pathway

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (Dalbavancin)Experimental Treatment1 Intervention

Dalbavancin 1500 mg will be administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for subjects with Creatinine Clearance (CrCl) <30 and not on dialysis. N=100

Group II: Arm 2 (Standard of Care)Active Control5 Interventions

For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks OR cefazolin (2 g will be administrated intravenously (IV) every 8 hours for 4-6 weeks) For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg will be administrated intravenously (IV) daily for 4-6 weeks). N=100

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalbavancin

2014

Completed Phase 4

~2050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,480,932 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study admit seniors for participation?

"This trial is open to individuals aged between 18 and 99. Additionally, there are 18 studies for minors and 84 trials specifically designed for seniors above 65 years old."

Answered by AI

Is recruitment for this investigation currently open?

"Affirmative. According to the clinicaltrials.gov database, this research endeavour is actively searching for individuals that fulfill its criteria. This experiment was first published on April 22nd 2021 and recently revised on November 10th 2022; 200 patients are needed from 30 distinct sites."

Answered by AI

How many distinct sites are participating in this investigation?

"Patients are currently being recruited for this clinical trial out of 30 sites, with the most proximate ones located in Rockville, Tampa and Boston. To reduce journey requirements, it is recommended that participants select a clinic near to them when enrolling."

Answered by AI

Is it possible for me to become involved in this medical research experiment?

"For this medical trial, 200 individuals with bacteremia aged between 18 and 99 are eligible for enrollment. A few key requirements include obtaining written consent from the patient or their legal representative; receiving effective antibiotic therapy for at least three days (maximum 10); having no growth on blood cultures incubated for 48 hours; being willing to receive dalbavancin in two doses or standard of care intravenous monotherapy over 4-8 weeks from randomization; returning to the hospital/designated clinic as necessary; and finally, having a prognosis that suggests survival is possible when receiving antibiotics and supportive care throughout the study."

Answered by AI

To what extent is Dalbavancin a safe and effective treatment for patients?

"Our analysts at Power rated the safety of Dalbavancin as a 2, since this is currently in Phase 2 trials, making it safe to use but having no demonstrable efficacy data."

Answered by AI

What health conditions can Dalbavancin be employed to address?

"Dalbavancin is a viable option for treating staphylococcal infections and other bacterial issues like bacteremia, catheter-related contagions, and more."

Answered by AI

What former research has been carried out concerning Dalbavancin?

"Dalbavancin was initially studied in 2010 at Sacramento Pediatric Gastroenterology and has since seen 239 studies reach their conclusion. Currently, 73 trials are active, with a considerable amount of them taking place out of Rockville, Maryland."

Answered by AI

What is the scale of this research endeavor in terms of participants?

"Affirmative. According to clinicaltrials.gov, this investigation began on April 22nd 2021 and is still actively seeking patients with the most recent update being November 10th 2022. 200 volunteers are needed from 30 different locations in total."

Answered by AI

Recent research and studies

TrialsJournal

Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): Study Protocol for a Phase 2b, Multicenter, Randomized, Open-label Clinical Trial

Turner, Nicholas A., Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, et al.. 2022. “Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): Study Protocol for a Phase 2b, Multicenter, Randomized, Open-label Clinical Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06370-1.

clinicaltrials.govStudy

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

2021. "DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04775953.