Gram-Positive Bacterial InfectionsPhase 4NCT03982030
Dalbavancin Outpatient Pilot
A Phase 4 study testing Dalbavancin in people with Gram-Positive Bacterial Infections and Soft Tissue Infections, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Positive Bacterial Infections, Soft Tissue Infections
- What is being tested?
- Dalbavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jul 2025
- Phase
- Phase 4
- 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
- >=18 years of age
- Provide informed consent
- Agreement to attend required follow-up visits with reasonable transportation plan
- Afebrile for at least 24 hours prior to enrollment
- Expected survival ≥3 months
- If female, non-pregnant and non-lactating; all females of child-bearing potential must have a negative pregnancy test prior to study entry and must agree to use a highly effective method of birth control during the study and for one month thereafter.
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- Anticipated hospital discharge within 8 days
- Joint and bone infection:
- Sterile site culture positive for susceptible organism
- Participants with bacteremia and right-sided infective endocarditis (IE):
- 2 or more blood cultures positive for S. aureus (MSSA or MRSA or Streptococci)
- Blood cultures negative for 72 hours within 7 days on standard of care antibiotic therapy
- Definite diagnosis of right sided infective endocarditis by Duke Criteria
- Echocardiographic assessment (TTE or TEE)
- For patients with opioid use disorder and history of injection opioid use,
- Injection of opioid substances (IOS) in the last 6 months
- Fulfill criteria for opioid use disorder
Who cannot join
- Polymicrobial infection
- Baseline QTc >500 msec
- Creatinine clearance <30 mL per min
- Immunocompromised from neutropenia, AIDS, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable)
- Patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin
- Concurrent diseases that, in the Investigator's medical judgment, would interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
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- For participants with right-sided IE:
- No mitral or aortic valve involvement on echocardiogram
- Large, mobile vegetations (>10mm)
- Perivalvular abscess
- Presence of an intracardiac device (defibrillator or pacer) or prosthetic valve
About this study
Official title: An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.
Read the detailed description
A phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.
- Being tested
- Dalbavancin
- Keywords
- Dalbavacin
- Medical subject headings
- Gram-Positive Bacterial Infections, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Also called Dalvance
Dalbavancin 1.5g IV at day 0, day 8-10
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin. Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with resolution of infection
Number of participants with no recurrent signs or symptom of infection
Measured: Week 6
Secondary outcomes (17)
Number of participants with development of breakthrough infection - week 6
Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Measured: Week 6
Number of participants with development of breakthrough infection - Month 6
Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Measured: Month 6
Number of participants with hospital readmission - week 6
Number of participants readmitted for the primary infection under treatment or related complication.
Measured: Week 6
Number of participants with hospital readmission - Month 6
Number of participants readmitted for the primary infection under treatment or related complication.
Measured: Month 6
Number of participants with need for further surgical intervention - week 6
Number of participants that need surgical intervention for primary infection prior to end of study participation.
Measured: Week 6
Number of participants with need for further surgical intervention - Month 6
Number of participants that need surgical intervention for primary infection prior to end of study participation.
Measured: Month 6
Number of adverse events leading to discontinuation of study drug -week 6
Measured: Week 6
Number of adverse events leading to discontinuation of study drug - Month 6
Measured: Month 6
Number of participants loss to follow-up - week 6
Number of participants that fail to receive second planned dalbavacin dose and attend study visits.
failure to attend scheduled visits after receiving second dalbavancin dose
Measured: Week 6
Number of participants loss to follow-up - Month 6
Number of participants that fail to receive second planned dalbavacin dose and attend study visits.
failure to attend scheduled visits after receiving second dalbavancin dose
Measured: Month 6
Costs of antibiotic therapy
Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
Measured: Month 6
Participant Study Questionnaire week 4
Participant satisfaction will be measured using the 5 point scale (4-strongly agree, 3-agree, 2 neutral, 1-disagree, and 0-strongly disagree). Higher scores denote better outcome.
Measured: week 4
Participant Study Questionnaire week 24
Participant satisfaction will be measured using the 5 point scale (4-strongly agree, 3-agree, 2 neutral, 1-disagree, and 0-strongly disagree). Higher scores denote better outcome.
Measured: Month 6
Number of participants with reported overdose
Measured: Month 6
Number of participants with new enrollment in addiction treatment
Measured: Month 6
Number of participants re-admitted for addiction-related issue
Measured: Month 6
Time investment per patient required to follow this model
Time investment per patient will be measured by combined time in minutes spent by study and clinical staff on addiction-related phone calls, paperwork and in-person appointments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study startApr 2023 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caryn Morse, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982030
- Sponsor's protocol ID
- IRB00054355
- Status last verified
- May 2023
- First submitted
- 10 Jun 2019
- Last updated
- 3 May 2023
- Results posted
- No
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT03982030
- Acronym / sponsor ID
- IRB00054355
- Keywords
- Dalbavacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Jun 2019 (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 purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.
Detailed description
A phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: DalbavancinParticipants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- >=18 years of age
- Provide informed consent
- Agreement to attend required follow-up visits with reasonable transportation plan
- Afebrile for at least 24 hours prior to enrollment
- Expected survival ≥3 months
Key exclusion criteria (11 listed)
- Polymicrobial infection
- Baseline QTc >500 msec
- Creatinine clearance <30 mL per min
- Immunocompromised from neutropenia, AIDS, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable)
- Patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin
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: DalvanceDalbavancin 1.5g IV at day 0, day 8-10 | Drug | Dalbavancin |
Primary outcome
Number of participants with resolution of infection
Time frame: Week 6
Number of participants with no recurrent signs or symptom of infection
17 secondary outcomes
Number of participants with development of breakthrough infection - week 6
Time frame: Week 6
Number of participants with development of breakthrough infection - Month 6
Time frame: Month 6
Number of participants with hospital readmission - week 6
Time frame: Week 6
Number of participants with hospital readmission - Month 6
Time frame: Month 6
Number of participants with need for further surgical intervention - week 6
Time frame: Week 6
Number of participants with need for further surgical intervention - Month 6
Time frame: Month 6
Number of adverse events leading to discontinuation of study drug -week 6
Time frame: Week 6
Number of adverse events leading to discontinuation of study drug - Month 6
Time frame: Month 6
Number of participants loss to follow-up - week 6
Time frame: Week 6
Number of participants loss to follow-up - Month 6
Time frame: Month 6
Costs of antibiotic therapy
Time frame: Month 6
Participant Study Questionnaire week 4
Time frame: week 4
Participant Study Questionnaire week 24
Time frame: Month 6
Number of participants with reported overdose
Time frame: Month 6
Number of participants with new enrollment in addiction treatment
Time frame: Month 6
Number of participants re-admitted for addiction-related issue
Time frame: Month 6
Time investment per patient required to follow this model
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
Related trials for Gram-Positive Bacterial Infections
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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 2
Oritavancin for Treatment of Serious Cardiac Infections
Infective Endocarditis, Cardiac Device Infection
Not yet recruiting
Oritavancin for CIED Infections With MDR Gram-positive Cocci
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RecruitingObservational study
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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.
Caryn Morse, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalbavancin in people with Gram-Positive Bacterial Infections and Soft Tissue Infections, run by Wake Forest University Health Sciences.
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 17 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: withdrawn, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 participants with resolution of infection (time frame: Week 6). 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 3 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.