What is the mechanism of action of this treatment?

The most common treatments for MRSA, such as dalbavancin, vancomycin, and ceftaroline, work by inhibiting bacterial cell wall synthesis. Dalbavancin and vancomycin bind to the D-alanyl-D-alanine terminus of cell wall precursors, preventing the cross-linking necessary for cell wall strength and integrity. Ceftaroline, a beta-lactam antibiotic, binds to penicillin-binding proteins, disrupting cell wall synthesis. These mechanisms are vital for MRSA patients because they target the bacteria's ability to maintain a robust cell wall, leading to bacterial cell death and effectively treating infections that are resistant to other antibiotics.

What side effects are associated with this type of intervention?

Common treatments for MRSA that inhibit bacterial cell wall synthesis, such as vancomycin, daptomycin, and linezolid, have several known side effects. Vancomycin can cause nephrotoxicity and ototoxicity, and may lead to 'Red Man Syndrome,' a rash that occurs with rapid infusion. Daptomycin is associated with muscle toxicity, including myopathy and rhabdomyolysis, and can cause eosinophilic pneumonia. Linezolid can lead to bone marrow suppression, resulting in thrombocytopenia and anemia, and has been linked to serotonin syndrome when used with serotonergic drugs. These side effects should be carefully monitored during treatment.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of MRSA, focusing on those that inhibit bacterial cell wall synthesis. Vancomycin, a glycopeptide antibiotic, has been a cornerstone in treating MRSA infections. Ceftaroline, a cephalosporin, is another FDA-approved option effective against MRSA. Additionally, Daptomycin, although not a cell wall synthesis inhibitor, is often used in combination with ceftaroline for persistent MRSA bacteremia. These treatments provide a range of options for managing MRSA infections, particularly in cases where resistance to other antibiotics is a concern.

What other types of research exist?

Promising novel alternatives to Dalbavancin for MRSA treatment include: <ol> <li>Linezolid: Effective for osteoarticular infections and resistant gram-positive infections in children.</li> <li>Daptomycin: Shown efficacy in pediatric patients with staphylococcal bacteremia and acute hematogenous osteomyelitis.</li> <li>Ceftaroline: A novel cephalosporin with activity against MRSA, used in skin and skin structure infections.</li> <li>Oritavancin: Single-dose treatment for acute bacterial skin and skin structure infections.</li> <li>Delafloxacin: Effective in acute bacterial skin and skin structure infections, including MRSA.</li> </ol>

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Glycopeptide Antibiotic

Dalbavancin for Bacterial Skin Infections

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 min (end of infusion on day 1); 2 hrs after start of iv (day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of iv

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and effectiveness of dalbavancin, an antibiotic, in treating skin infections in children aged birth to 17 years. The infections are caused by specific bacteria, including those resistant to common antibiotics. Dalbavancin works by disrupting the bacteria's cell wall.

Who is the study for?

This trial is for children from birth to 17 years with serious skin infections, including those caused by MRSA. It's open to kids showing signs like fever or abnormal white blood cell counts and who need hospitalization. Babies under 3 months must meet additional criteria. Kids can't join if they have significant liver or kidney issues, recent investigational drug use, certain severe infections, immune problems, or are pregnant/nursing.

What is being tested?

The study tests the safety and effectiveness of dalbavancin in treating children's bacterial skin infections. Dalbavancin will be given either as a single dose or two doses to see which works better against Gram-positive bacteria like MRSA that cause these infections.

What are the potential side effects?

Dalbavancin may cause side effects such as allergic reactions, digestive issues (like nausea and diarrhea), changes in liver enzymes (which might indicate liver irritation), infusion-related reactions (like rash or itching), and possibly blood disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 min (end of infusion on day 1); 2 hrs after start of iv (day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of iv

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 min (end of infusion on day 1); 2 hrs after start of iv (day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of iv

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 min (end of infusion on day 1); 2 hrs after start of iv (day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of iv for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Shift From Baseline in Acoustic Immittance Test at TOC Visit

Shift From Baseline in Auditory Brainstem Response Test at TOC Visit

Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit

+2 more

Secondary study objectives

All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants

Clinical Response at 48-72 Hours

Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)

+21 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT03233438

Hypoglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Usual Care

New Critical Pathway

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Dalbavancin two-doseExperimental Treatment1 Intervention

Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.

Group II: Dalbavancin single-doseExperimental Treatment1 Intervention

Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.

Group III: ComparatorActive Control5 Interventions

Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalbavancin

2014

Completed Phase 4

~2250

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for MRSA, such as dalbavancin, vancomycin, and ceftaroline, work by inhibiting bacterial cell wall synthesis. Dalbavancin and vancomycin bind to the D-alanyl-D-alanine terminus of cell wall precursors, preventing the cross-linking necessary for cell wall strength and integrity. Ceftaroline, a beta-lactam antibiotic, binds to penicillin-binding proteins, disrupting cell wall synthesis. These mechanisms are vital for MRSA patients because they target the bacteria's ability to maintain a robust cell wall, leading to bacterial cell death and effectively treating infections that are resistant to other antibiotics.