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Dalbavancin Outpatient Pilot

An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03982030
Enrollment
0
Registered
2019-06-11
Start date
2023-04-30
Completion date
2025-07-31
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-Positive Bacterial Infections, Soft Tissue Infections

Keywords

Dalbavacin

Brief 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.

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.

Interventions

DRUGDalbavancin

Dalbavancin 1.5g IV at day 0, day 8-10

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion * \>=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. * 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 Exclusion * 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with resolution of infectionWeek 6Number of participants with no recurrent signs or symptom of infection

Secondary

MeasureTime frameDescription
Number of participants with development of breakthrough infection - Month 6Month 6Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Number of participants with hospital readmission - week 6Week 6Number of participants readmitted for the primary infection under treatment or related complication.
Number of participants with hospital readmission - Month 6Month 6Number of participants readmitted for the primary infection under treatment or related complication.
Number of participants with need for further surgical intervention - week 6Week 6Number of participants that need surgical intervention for primary infection prior to end of study participation.
Number of participants with need for further surgical intervention - Month 6Month 6Number of participants that need surgical intervention for primary infection prior to end of study participation.
Number of adverse events leading to discontinuation of study drug -week 6Week 6
Number of adverse events leading to discontinuation of study drug - Month 6Month 6
Number of participants loss to follow-up - week 6Week 6Number of participants that fail to receive second planned dalbavacin dose and attend study visits. failure to attend scheduled visits after receiving second dalbavancin dose
Number of participants with development of breakthrough infection - week 6Week 6Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Costs of antibiotic therapyMonth 6Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
Participant Study Questionnaire week 4week 4Participant 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.
Participant Study Questionnaire week 24Month 6Participant 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.
Number of participants with reported overdoseMonth 6
Number of participants with new enrollment in addiction treatmentMonth 6
Number of participants re-admitted for addiction-related issueMonth 6
Time investment per patient required to follow this model6 monthsTime 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.
Number of participants loss to follow-up - Month 6Month 6Number of participants that fail to receive second planned dalbavacin dose and attend study visits. failure to attend scheduled visits after receiving second dalbavancin dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026