Dalbavancin for Gram-Positive Bacterial Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Colorado Hospital, Aurora, CO
Gram-Positive Bacterial Infections+8 More
Dalbavancin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a 2-dose dalbavancin regimen is more effective than a standard 3-dose regimen in treating serious infections due to gram-positive organisms susceptible to vancomycin in people who use drugs.

See full description

Eligible Conditions

  • Gram-Positive Bacterial Infections
  • Intravenous Drug Abuse
  • Substance Use Disorders (SUD)
  • Gram-Positive Bacteraemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gram-Positive Bacterial Infections

Study Objectives

This trial is evaluating whether Dalbavancin will improve 13 primary outcomes in patients with Gram-Positive Bacterial Infections. Measurement will happen over the course of 4 weeks from the start of dalbavancin therapy.

12 months
percentage of patients with at least one adverse event
Month 12
percentage of patients with relapse of the principal infectious diagnosis
Week 4
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 4 weeks
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 4 weeks
Week 6
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 6 weeks
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 6 weeks
percentage of patients with improvement of the principal infectious diagnosis by improvement in imaging within 6 weeks (where applicable)
Day 7
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 7 days
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 7 days
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days
percentage of patients with improvement of the principal infectious diagnosis by resolution of bacteremia (where applicable) within 7 days

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gram-Positive Bacterial Infections

Side Effects for

Usual Care
Hypoglycaemia
2%
Pyrexia
0%
Cellulitis
0%
Vomiting
0%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03233438) in the Usual Care ARM group. Side effects include: Hypoglycaemia with 2%, Pyrexia with 0%, Cellulitis with 0%, Vomiting with 0%.

Trial Design

1 Treatment Group

people who use drugs with severe Gram-positive infections
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. Dalbavancin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

people who use drugs with severe Gram-positive infections
Drug
As per inclusion and exclusion criteria
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

University of Colorado Hospital - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects 18+ years of age with bacteremia or deep seated infections (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema)
Subjects will have injection drug use (IDU) (or SUD) listed as the barrier to OPAT,
Their principal admission diagnosis will require 2 or more weeks of antibiotic treatment for indications, including bacteremia, endocarditis, osteomyelitis and other deep-seated infections with Sa/gpp sensitive to vancomycin
No more than 7 days have past since the first positive qualifying culture
if their infection is directly linked with IDU
if they report active psychoactive substance without evidence of remission prior to hospitalization (including prescription medications they have not been authorized to use by any prescribing physician but excluding alcohol and/or tobacco products alone)
if their toxicology screen shows illicit substances (including prescription medications they have not been authorized to use by any prescribing physician)

Patient Q&A Section

Can gram-positive bacterial infections be cured?

"We can conclude that antibiotics can cure most cases of gram-positive bacterial bacterial infections. However, this cure is incomplete unless the disease has been treated for three weeks for gram-positive bacteria and for one week for gram-negative bacteria." - Anonymous Online Contributor

Unverified Answer

How many people get gram-positive bacterial infections a year in the United States?

"More than 6% of Americans get a gram-positive bacterial infection a year, similar to national rates reported in the CDC reports. The percentage is increasing over time in children and younger adults." - Anonymous Online Contributor

Unverified Answer

What causes gram-positive bacterial infections?

"Gram-positive bacteria and their virulence factors are present in a wide range of different infections. A major role for a number of these is the ability to adhere to host tissue during infection, which facilitates host damage and disease. Infections that are not caused by gram-negative bacteria can be associated with gram-positive bacteria that adher to host proteins.\n" - Anonymous Online Contributor

Unverified Answer

What does dalbavancin usually treat?

"Treatment-based on a culture result (negative/positive) for gram-positive organisms is associated with lower rates of Gram-negative bacteremia and mortality than treatment based on culture results for all common pathogens. ClinicalTrials.gov: NCT00361678." - Anonymous Online Contributor

Unverified Answer

What are the signs of gram-positive bacterial infections?

"Most children with bacterial infections are asymptomatic and have no clinically evident signs. Some signs can be identified on examinations and physical examinations. The presence of fever, enlarged chest and enlarged liver or spleen are indicative of bacterial pneumonia. Abdominal tenderness may indicate abscess or peritonitis. Hematologic abnormalities may suggest sepsis, and neurological defects may indicate meningitic infection in infants. Children with gastroenteritis may present with abdominal pain or vomiting. Fever, vomiting, and diarrhea may also be the presenting signs of gastroenteritis associated with bacterial infections." - Anonymous Online Contributor

Unverified Answer

What is gram-positive bacterial infections?

"A common way of categorizing infectious agents in immunocompromised individuals is by their susceptibility to tetracycline, which can be used to characterize the organism in question. The present review focuses mostly on gram-positive bacterial infections. In this regard, the following organisms are all susceptible to tetracycline: Streptococcus pneumoniae, Neisseria meningitidis, Streptococcus pyogenes, and Haemophilus influenzae Type b." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gram-positive bacterial infections?

"Antibiotics are a common treatment for most infections by gram-positive bacteria. In many situations, there is controversy whether to use antibiotics in certain groups of children. Clinical trials, however, are scarce and not often cited. Antibiotic resistance is increasing worldwide, so antibiotics will likely remain an important part of treatment for most infections caused by gram-positive bacteria. Clinical trials of antibiotics in children with certain types of infections are needed to help clarify who will benefit from treatment." - Anonymous Online Contributor

Unverified Answer

Is dalbavancin typically used in combination with any other treatments?

"The frequency and proportion of the treatment regimens are largely defined by the dalbavancin label-manufacturer's clinical experience in the management of the respective drug. These are discussed in detail, including possible interactions with concomitant agents and appropriate dosing, in the following sections. The dalbavancin label does not provide information on dosing in combination therapies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dalbavancin?

"These include nausea and vomiting, headache, dizziness, and abnormal liver tests. When discontinuation of therapy is necessary, a delay of 7 days is recommended. People with a history of agranulocytosis should not restart dalbavancin and, moreover, should stop taking other oral antiphagocytic agents for 3 months before starting dalbavancin if they had had agranulocytosis." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gram-positive bacterial infections?

"In a recent study, findings indicate that a single-center study in Taiwan provided reliable and reliable data which should contribute to the prevention of complications of this microbe. To obtain a clearer view of the problem, additional multi-center, multi-national research should continue." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating gram-positive bacterial infections?

"Only 12 of the 23 drugs studied were effective against gram-positive infections that were resistant to common antibiotics such as β-lactams and aminoglycosides. However, there were several effective compounds for the treatment of S. aureus bacteremia, including ceftriaxone, linezolid, and arbekacin. Most importantly, new antibiotics were effective against MDRSE and MMRSA, but more studies are needed to validate their efficacies." - Anonymous Online Contributor

Unverified Answer

How serious can gram-positive bacterial infections be?

"For those with a positive microbiological culture and without apparent risk factors, the mortality is very low (4.5% according to the NINDS criteria). In contrast, mortality is substantial among patients with a known or high risk for MRSA and/or Enterococcus spp. Infections with MRSA were associated with a high mortality irrespective of their etiology. Mortality remains very low for those with E coli or S pneumoniae bacteremia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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