Gram-Positive Bacterial InfectionsPhase 2/3SUDDEN-OUTNCT04847921
Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition
A Phase 2/3 study testing Dalbavancin in people with Gram-Positive Bacterial Infections and Gram-Positive Bacteraemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Positive Bacterial Infections, Gram-Positive Bacteraemia, Substance Use Disorders
- What is being tested?
- Dalbavancin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 5 Oct 2023
- Phase
- Phase 2/3
- 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
- Subjects 18+ years of age with bacteremia or deep seated infections (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema)
- Subjects will have injection drug use (IDU) (or SUD) listed as the barrier to OPAT, and
- Their principal admission diagnosis will require 2 or more weeks of antibiotic treatment for indications, including bacteremia, endocarditis, osteomyelitis and other deep-seated infections with Sa/gpp sensitive to vancomycin
- No more than 7 days have past since the first positive qualifying culture
- The subjects will be considered to have an active SUD or IDU:
- if their infection is directly linked with IDU
- if they report active psychoactive substance without evidence of remission prior to hospitalization (including prescription medications they have not been authorized to use by any prescribing physician but excluding alcohol and/or tobacco products alone)
- if their toxicology screen shows illicit substances (including prescription medications they have not been authorized to use by any prescribing physician)
Who cannot join
- Have an allergy to dalbavancin (or other glycopeptide antibiotics, i.e. vancomycin)
- Cannot have a peripheral access (i.e. need surgical central access due to poor vasculature), or if they need constant IV access for other IV medications which need to be administered frequently
- Have central nervous system (CNS) infections or spinal epidural abscess due to its proximity to CNS (risk of invasion) as the penetration of dalbavancin into the CNS has not been sufficiently studied
- Have infected implants/prosthetic devices, unless the management includes removal of infected foreign material
- Complicated left-sided endocarditis meeting criteria for early surgical intervention based on current Infectious Disease Society of America (IDSA) guidelines for management of infective endocarditis (https://www.idsociety.org/globalassets/idsa/practice-guidelines/infective-endocarditis-in-adults-diagnosis-antimicrobial-therapy-and-management-of-complications.pdf)
- Have a significant psychiatric or cognitive deficit which does not meet the criteria for inpatient psychiatric hospitalization but which would, nevertheless, preclude meaningful engagement in substance use disorder treatment and infectious disease follow up
Show all 11Show fewer
- Are incarcerated
- Have any other condition or abnormality that in the opinion of the investigators would compromise the safety of the patient or the quality of the data may will also be considered as a criterion for exclusion
- Need long-term suppression with antibiotics after completion of the IV course, as this would render their follow up data uninterpretable from the infectious disease perspective (i.e. hardware associated osteoarticular infections)
- Pregnant women (though no contraception will be required to prevent pregnancy during the study, as dalbavancin is not contraindicated in pregnancy in its Food and Drug Administration (FDA) approved indication; the exclusion aims to prevent dalbavancin use in patients with less predictable pharmacokinetic/pharmacodynamic (PK/PD) which is known to occur in pregnancy)
- Patients with creatinine clearance (CrCl) <30mL/min and those with end-stage renal disease (ESRD) on any renal replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections
The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.
Read the detailed description
This project is designed to study the outcomes of serious infections, including bacteremia, endocarditis and other deep-seated infection (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema, excluding simple acute bacterial skin and soft structure infections (ABSSSI) and central nervous system (CNS) infections) due to gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD).
The short-term goal of this project is to establish improved outcomes in the treatment of serious vancomycin susceptible Gram-positive infections in PWUD by a simplified 2-dose antibacterial regimen of long-acting lipoglycopeptide dalbavancin, which does not require maintenance of intravenous (IV) access. Excluding the need for IV maintenance is desirable to mitigate some of the widely held safety concerns in this population, including IV access misuse which may lead to IV access contamination and blood stream infections, as well as other concerns regarding compliance with more complex regimens in this population.
The long-term goal is to establish that such treatment will lead to better outcomes for the infectious diagnoses as compared to current standard of care in this population. The Investigators hypothesize, that this approach will not only improve the compliance with antimicrobial therapy but the obvious connection between the admission diagnosis (serious infection) and substance abuse will serve as a motivating factor for the patients to engage in addressing the true underlying cause of their infection - substance use disorder (SUD). SUD treatment is frequently time-consuming and often unavailable in the acute hospitalization environment and the patients' transitions (e.g. residential SUD treatment, intensive outpatient (IOP), outpatient-based opioid therapy (OBOT)) will be facilitated by the flexibility of our approach vs current standard of care regarding antibiotic therapy.
This study will enroll only patients with SUD as a unifying characteristic preventing the use of traditional outpatient parenteral antimicrobial therapy (OPAT). All consenting patients will be treated with dalbavancin and will be monitored inpatient until their 2nd/last dose of the drug. This should shorten their acute hospitalization to 10-14 days maximum. During this period, they will also be evaluated by an addiction medicine specialist and a substance use counselor for the appropriate post-discharge level of care by American Society of Addiction Medicine (ASAM) criteria (Continuum software) and initiated on medication-assisted therapy (MAT) as indicated. Appropriate evaluation of all subjects by ASAM Continuum will facilitate evidence based recommendations for placement and/or immediate follow up for post-discharge SUD treatment and monitoring. It will also allow for qualitative and quantitative reporting of the experience and associated outcomes. The aim of this intervention is to further inform the implementation of SUD care continuum for patients hospitalized with acute SUD-related serious infections.
- Conditions
- Gram-Positive Bacterial Infections, Gram-Positive Bacteraemia, Substance Use Disorders, Intravenous Substance Abuse
- Being tested
- Dalbavancin
- Medical subject headings
- Gram-Positive Bacterial Infections, Substance-Related Disorders, Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Also called Dalvance
long-acting lipoglycopeptide antibacterial agent
| Study group | Role | What they receive |
|---|---|---|
| people who use drugs with severe Gram-positive infections | Experimental | As per inclusion and exclusion criteria Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
Measured: 7 days from the start of dalbavancin therapy
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 4 weeks
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
Measured: 4 weeks from the start of dalbavancin therapy
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 6 weeks
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
Measured: 6 weeks from the start of dalbavancin therapy
percentage of patients with improvement of the principal infectious diagnosis by improvement in imaging within 6 weeks (where applicable)
improvement in the principal infectious diagnosis by improved lesions on imaging
Measured: 6 weeks from the start of dalbavancin therapy
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 7 days
improvement in ESR (normalization or improvement from index study visit)
Measured: 7 days from the start of dalbavancin therapy
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 4 weeks
improvement in ESR (normalization or improvement from index study visit)
Measured: 4 weeks from the start of dalbavancin therapy
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 6 weeks
improvement in ESR (normalization or improvement from index study visit)
Measured: 6 weeks from the start of dalbavancin therapy
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 7 days
improvement in CRP (normalization or improvement from index study visit)
Measured: 7 days from the start of dalbavancin therapy
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks
improvement in CRP (normalization or improvement from index study visit)
Measured: 4 weeks from the start of dalbavancin therapy
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks
improvement in CRP (normalization or improvement from index study visit)
Measured: 6 weeks from the start of dalbavancin therapy
percentage of patients with improvement of the principal infectious diagnosis by resolution of bacteremia (where applicable) within 7 days
improvement in the principal infectious diagnosis by resolution of bacteremia (where applicable)
Measured: 7 days from the start of dalbavancin therapy
percentage of patients with relapse of the principal infectious diagnosis
evidence of relapse (excluding re-infection) assessed at each follow up visit until the end of study follow up (censored once occurred).
Measured: 12 months from the start of antimicrobial therapy or from the achievement of source control (whichever comes later)
percentage of patients with at least one adverse event
Safety and tolerability of dalbavancin evaluation as measured by the number of any confirmed or suspected treatment-emergent (not necessarily treatment related) complications or adverse events assessed daily during hospitalization and at each study visit after discharge from inpatient treatment (immediately after 2nd dose of dalbavancin, unless prevented by acute development of a medical condition requiring further hospitalization)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start30 Apr 2021
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Why it stopped: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Krsak, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847921
- Sponsor's protocol ID
- 19-0650
- Acronym
- SUDDEN-OUT
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krsak M, Scherger S, Miller MA, Cobb V, Montague BT, Henao-Martinez AF, Molina KC. Substance use disorder-associated infections' treatment with dalbavancin enabling outpatient transition (SUDDEN OUT) - an investigator-initiated single-arm unblinded prospective cohort study. Ther Adv Infect Dis. 2024 Jan 17;11:20499361231223889. doi: 10.1177/20499361231223889. eCollection 2024 Jan-Dec.
PubMed 38249543
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections
- ClinicalTrials.gov ID
- NCT04847921
- Acronym / sponsor ID
- SUDDEN-OUT / 19-0650
- Conditions
- Gram-Positive Bacterial Infections, Gram-Positive Bacteraemia, Substance Use Disorders, Intravenous Substance Abuse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 19 Apr 2021 (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.
The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.
Detailed description
This project is designed to study the outcomes of serious infections, including bacteremia, endocarditis and other deep-seated infection (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema, excluding simple acute bacterial skin and soft structure infections (ABSSSI) and central nervous system (CNS) infections) due to gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD).
The short-term goal of this project is to establish improved outcomes in the treatment of serious vancomycin susceptible Gram-positive infections in PWUD by a simplified 2-dose antibacterial regimen of long-acting lipoglycopeptide dalbavancin, which does not require maintenance of intravenous (IV) access. Excluding the need for IV maintenance is desirable to mitigate some of the widely held safety concerns in this population, including IV access misuse which may lead to IV access contamination and blood stream infections, as well as other concerns regarding compliance with more complex regimens in this population.
The long-term goal is to establish that such treatment will lead to better outcomes for the infectious diagnoses as compared to current standard of care in this population. The Investigators hypothesize, that this approach will not only improve the compliance with antimicrobial therapy but the obvious connection between the admission diagnosis (serious infection) and substance abuse will serve as a motivating factor for the patients to engage in addressing the true underlying cause of their infection - substance use disorder (SUD). SUD treatment is frequently time-consuming and often unavailable in the acute hospitalization environment and the patients' transitions (e.g. residential SUD treatment, intensive outpatient (IOP), outpatient-based opioid therapy (OBOT)) will be facilitated by the flexibility of our approach vs current standard of care regarding antibiotic therapy.
This study will enroll only patients with SUD as a unifying characteristic preventing the use of traditional outpatient parenteral antimicrobial therapy (OPAT). All consenting patients will be treated with dalbavancin and will be monitored inpatient until their 2nd/last dose of the drug. This should shorten their acute hospitalization to 10-14 days maximum. During this period, they will also be evaluated by an addiction medicine specialist and a substance use counselor for the appropriate post-discharge level of care by American Society of Addiction Medicine (ASAM) criteria (Continuum software) and initiated on medication-assisted therapy (MAT) as indicated. Appropriate evaluation of all subjects by ASAM Continuum will facilitate evidence based recommendations for placement and/or immediate follow up for post-discharge SUD treatment and monitoring. It will also allow for qualitative and quantitative reporting of the experience and associated outcomes. The aim of this intervention is to further inform the implementation of SUD care continuum for patients hospitalized with acute SUD-related serious infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| people who use drugs with severe Gram-positive infections | Experimental | Drug: DalbavancinAs per inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 18+ years of age with bacteremia or deep seated infections (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema)
- Subjects will have injection drug use (IDU) (or SUD) listed as the barrier to OPAT, and
- Their principal admission diagnosis will require 2 or more weeks of antibiotic treatment for indications, including bacteremia, endocarditis, osteomyelitis and other deep-seated infections with Sa/gpp sensitive to vancomycin
- No more than 7 days have past since the first positive qualifying culture
- The subjects will be considered to have an active SUD or IDU:
Key exclusion criteria (11 listed)
- Have an allergy to dalbavancin (or other glycopeptide antibiotics, i.e. vancomycin)
- Cannot have a peripheral access (i.e. need surgical central access due to poor vasculature), or if they need constant IV access for other IV medications which need to be administered frequently
- Have central nervous system (CNS) infections or spinal epidural abscess due to its proximity to CNS (risk of invasion) as the penetration of dalbavancin into the CNS has not been sufficiently studied
- Have infected implants/prosthetic devices, unless the management includes removal of infected foreign material
- Complicated left-sided endocarditis meeting criteria for early surgical intervention based on current Infectious Disease Society of America (IDSA) guidelines for management of infective endocarditis (https://www.idsociety.org/globalassets/idsa/practice-guidelines/infective-endocarditis-in-adults-diagnosis-antimicrobial-therapy-and-management-of-complications.pdf)
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 |
|---|---|---|
| DalbavancinAlso: Dalvancelong-acting lipoglycopeptide antibacterial agent | Drug | people who use drugs with severe Gram-positive infections |
Primary outcome
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days
Time frame: 7 days from the start of dalbavancin therapy
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 4 weeks
Time frame: 4 weeks from the start of dalbavancin therapy
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 6 weeks
Time frame: 6 weeks from the start of dalbavancin therapy
improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)
percentage of patients with improvement of the principal infectious diagnosis by improvement in imaging within 6 weeks (where applicable)
Time frame: 6 weeks from the start of dalbavancin therapy
improvement in the principal infectious diagnosis by improved lesions on imaging
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 7 days
Time frame: 7 days from the start of dalbavancin therapy
improvement in ESR (normalization or improvement from index study visit)
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 4 weeks
Time frame: 4 weeks from the start of dalbavancin therapy
improvement in ESR (normalization or improvement from index study visit)
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 6 weeks
Time frame: 6 weeks from the start of dalbavancin therapy
improvement in ESR (normalization or improvement from index study visit)
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 7 days
Time frame: 7 days from the start of dalbavancin therapy
improvement in CRP (normalization or improvement from index study visit)
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks
Time frame: 4 weeks from the start of dalbavancin therapy
improvement in CRP (normalization or improvement from index study visit)
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks
Time frame: 6 weeks from the start of dalbavancin therapy
improvement in CRP (normalization or improvement from index study visit)
percentage of patients with improvement of the principal infectious diagnosis by resolution of bacteremia (where applicable) within 7 days
Time frame: 7 days from the start of dalbavancin therapy
improvement in the principal infectious diagnosis by resolution of bacteremia (where applicable)
percentage of patients with relapse of the principal infectious diagnosis
Time frame: 12 months from the start of antimicrobial therapy or from the achievement of source control (whichever comes later)
evidence of relapse (excluding re-infection) assessed at each follow up visit until the end of study follow up (censored once occurred).
percentage of patients with at least one adverse event
Time frame: 12 months
Safety and tolerability of dalbavancin evaluation as measured by the number of any confirmed or suspected treatment-emergent (not necessarily treatment related) complications or adverse events assessed daily during hospitalization and at each study visit after discharge from inpatient treatment (immediately after 2nd dose of dalbavancin, unless prevented by acute development of a medical condition requiring further hospitalization)
Results and safety
The study was stopped early (reason given: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 38249543Krsak M, Scherger S, Miller MA, Cobb V, Montague BT, Henao-Martinez AF, Molina KC. Substance use disorder-associated infections' treatment with dalbavancin enabling outpatient transition (SUDDEN OUT) - an investigator-initiated single-arm unblinded prospective cohort study. Ther Adv Infect Dis. 2024 Jan 17;11:20499361231223889. doi: 10.1177/20499361231223889. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No
Related trials for Gram-Positive Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
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.
Martin Krsak, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dalbavancin in people with Gram-Positive Bacterial Infections and Gram-Positive Bacteraemia, run by University of Colorado, Denver 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 8 inclusion and 11 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 19 Oct 2023. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.). Results are not available in the source record.
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?
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days (time frame: 7 days from the start of dalbavancin therapy). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847921, which also lists 1 linked publication.
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 19 Oct 2023.