Dalbavancin Outpatient Pilot

Phase 4

Withdrawn

• Conditions: Gram-Positive Bacterial Infections; Soft Tissue Infections
• Interventions: Drug: Dalbavancin

• Registration Number: NCT03982030
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-11
• Study Start: 2023-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dalbavancin	Dalbavancin	Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.

Primary Outcome Measures

Name	Time	Method
Number of participants with resolution of infection	Week 6	Number of participants with no recurrent signs or symptom of infection

Secondary Outcome Measures

Name	Time	Method
Number of participants loss to follow-up - week 6	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
Number of participants with hospital readmission - Month 6	Month 6	Number of participants readmitted for the primary infection under treatment or related complication.
Number of participants with development of breakthrough infection - week 6	Week 6	Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Number of participants with need for further surgical intervention - Month 6	Month 6	Number 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 - Month 6	Month 6
Number of participants with hospital readmission - week 6	Week 6	Number of participants readmitted for the primary infection under treatment or related complication.
Number of participants with need for further surgical intervention - week 6	Week 6	Number of participants that need surgical intervention for primary infection prior to end of study participation.
Participant Study Questionnaire week 4	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.
Participant Study Questionnaire week 24	Month 6	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.
Number of participants with new enrollment in addiction treatment	Month 6
Number of participants with development of breakthrough infection - Month 6	Month 6	Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Number of adverse events leading to discontinuation of study drug -week 6	Week 6
Number of participants with reported overdose	Month 6
Number of participants re-admitted for addiction-related issue	Month 6
Number of participants loss to follow-up - Month 6	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
Costs of antibiotic therapy	Month 6	Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
Time investment per patient required to follow this model	6 months	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.