Dalbavancin Outpatient Pilot

Gram-Positive Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03982030
• Other study ID #: IRB00054355
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infections
• Soft Tissue Infections

Intervention

Drug:
• Dalbavancin
Dalbavancin 1.5g IV at day 0, day 8-10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with resolution of infection	Number of participants with no recurrent signs or symptom of infection	Week 6
Secondary	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.	Week 6
Secondary	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.	Month 6
Secondary	Number of participants with hospital readmission - week 6	Number of participants readmitted for the primary infection under treatment or related complication.	Week 6
Secondary	Number of participants with hospital readmission - Month 6	Number of participants readmitted for the primary infection under treatment or related complication.	Month 6
Secondary	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.	Week 6
Secondary	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.	Month 6
Secondary	Number of adverse events leading to discontinuation of study drug -week 6		Week 6
Secondary	Number of adverse events leading to discontinuation of study drug - Month 6		Month 6
Secondary	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	Week 6
Secondary	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	Month 6
Secondary	Costs of antibiotic therapy	Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.	Month 6
Secondary	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.	week 4
Secondary	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.	Month 6
Secondary	Number of participants with reported overdose		Month 6
Secondary	Number of participants with new enrollment in addiction treatment		Month 6
Secondary	Number of participants re-admitted for addiction-related issue		Month 6
Secondary	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.	6 months