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出境医 / 临床实验 / Dalbavancin Outpatient Pilot
Dalbavancin Outpatient Pilot
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gram-Positive Bacterial Infections Soft Tissue Infections | Drug: Dalbavancin | Phase 4 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy |
| Estimated Study Start Date : | August 2021 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | March 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Dalbavancin
Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.
|
Drug: Dalbavancin
Dalbavancin 1.5g IV at day 0, day 8-10
Other Name: Dalvance
|
Outcome Measures
Primary Outcome Measures :
- Number of participants with resolution of infection [ Time Frame: Week 6 ]Number of participants with no recurrent signs or symptom of infection
Secondary Outcome Measures :
- Number of participants with development of breakthrough infection - week 6 [ Time Frame: Week 6 ]Number of participants with worsening signs or symptoms of primary infection or development of new infection.
- Number of participants with development of breakthrough infection - Month 6 [ Time Frame: Month 6 ]Number of participants with worsening signs or symptoms of primary infection or development of new infection.
- Number of participants with hospital readmission - week 6 [ Time Frame: Week 6 ]Number of participants readmitted for the primary infection under treatment or related complication.
- Number of participants with hospital readmission - Month 6 [ Time Frame: Month 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 [ Time Frame: Week 6 ]Number 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 6 [ Time Frame: 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 -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 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 loss to follow-up - Month 6 [ Time Frame: 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 [ Time Frame: Month 6 ]Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
- Participant Study Questionnaire week 4 [ Time Frame: 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 [ Time Frame: 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 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 ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Caryn G Morse, MD | (336) 716-2700 | cmorse@wakehealth.edu | |
| Contact: Erin Barnes, MD | (336) 716-2700 | ebarnes@wakehealth.edu |
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
| Principal Investigator: | Caryn Morse, MD | Wake Forest University Health Sciences |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||||
| First Posted Date ICMJE | June 11, 2019 | ||||||||
| Last Update Posted Date | March 2, 2021 | ||||||||
| Estimated Study Start Date ICMJE | August 2021 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of participants with resolution of infection [ Time Frame: Week 6 ] Number of participants with no recurrent signs or symptom of infection
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dalbavancin Outpatient Pilot | ||||||||
| Official Title ICMJE | An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Drug: Dalbavancin
Dalbavancin 1.5g IV at day 0, day 8-10
Other Name: Dalvance
|
||||||||
| Study Arms ICMJE | Experimental: Dalbavancin
Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.
Intervention: Drug: Dalbavancin
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
24 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 2023 | ||||||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion
Exclusion
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03982030 | ||||||||
| Other Study ID Numbers ICMJE | IRB00054355 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Wake Forest University Health Sciences | ||||||||
| Study Sponsor ICMJE | Wake Forest University Health Sciences | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Wake Forest University Health Sciences | ||||||||
| Verification Date | July 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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