Dalbavancin for Bacterial Skin Infections

Recruiting at 119 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Renal impairment, Hepatic impairment, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10-14 days

199 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been on any systemic antibacterial therapy for more than 24 hours within 96 hours before joining the trial, you may not be eligible unless there was a treatment failure. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Dalbavancin for bacterial skin infections?

Dalbavancin has been shown to be effective in treating complicated skin infections, with clinical success rates of 88.9% to 94% in trials, and it works well against tough bacteria like MRSA. It's also been found to be as effective as other antibiotics like linezolid and vancomycin in these cases. ^{1 2 3 4 5}

Is Dalbavancin safe for treating bacterial skin infections?

Dalbavancin is generally considered safe for treating bacterial skin infections, with studies showing a positive benefit-risk profile. In a German study, no adverse events were linked to dalbavancin, and similar safety findings were reported in other countries. ^{2 4 5 6 7}

How is the drug Dalbavancin different from other treatments for bacterial skin infections?

Dalbavancin is unique because it is a long-acting antibiotic that can be administered once weekly, reducing the need for frequent hospital visits. It is effective against resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA) and has a longer half-life, which means it stays in the body longer, potentially leading to shorter hospital stays. ^{1 2 3 4 8}

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

You have a skin infection with certain symptoms like fever, high or low white blood cell count, or infection involving deeper tissue that needs major surgery.

You have a severe skin infection, surgical wound infection, or a deep skin infection called cellulitis.

Babies under 3 months old with certain infections or blood poisoning, and who meet specific medical and lab test requirements.

Exclusion Criteria

You have a serious liver problem.

Treatment with an investigational drug within 30 days preceding the first dose of study medication

Children with serious kidney problems cannot participate, and babies under three months old with moderate or severe kidney problems also cannot participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dalbavancin or comparator treatment for acute bacterial skin and skin structure infections

10-14 days

Multiple visits for IV administration and monitoring

Test of Cure (TOC)

Assessment of clinical and microbiological response to treatment

28 days from baseline

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

54 days from baseline

1 visit (in-person)

Treatment Details

Interventions

• Dalbavancin

Trial Overview 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.

Participant Groups

Group I: Dalbavancin two-dose Experimental Treatment 1 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-dose Experimental Treatment 1 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: Comparator Active Control 5 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.

Dalbavancin is already approved in United States for the following indications:

Approved in United States as Dalvance for:

• Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

Dalbavancin is a potent new antibiotic that shows greater in vitro effectiveness than vancomycin against various bacteria, including Staphylococcus aureus and Enterococcus spp., making it a promising treatment for serious infections.

In clinical trials, dalbavancin demonstrated comparable efficacy to established antibiotics like linezolid and vancomycin for treating complicated skin infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalbavancin, a long-acting lipoglycopeptide for the treatment of multidrug-resistant Gram-positive bacteria. Decousser, JW., Bourgeois-Nicolaos, N., Doucet-Populaire, F.[2014]

In a study involving 39 patients with uncomplicated S. aureus bacteremia, dalbavancin demonstrated a 100% clearance rate of the bloodstream infection, outperforming the 95% clearance rate seen in patients treated with comparators like vancomycin or linezolid.

Dalbavancin also showed a high clinical success rate of 92% at the end of treatment, comparable to the 78% success rate of the comparator therapies, indicating its efficacy as a treatment option for serious bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Gonzalez, PL., Rappo, U., Akinapelli, K., et al.[2022]

Dalbavancin is an effective antibiotic for treating acute bacterial skin infections, particularly against gram-positive bacteria like MRSA, with a much lower minimum inhibitory concentration than most other MRSA treatments.

Its extended half-life allows for a convenient dosing schedule of just two doses over a week, making it a practical option compared to traditional antibiotics like vancomycin, while showing similar efficacy in clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalbavancin: A Novel Lipoglycopeptide Antibiotic with Extended Activity Against Gram-Positive Infections. Smith, JR., Roberts, KD., Rybak, MJ.[2020]

In a study of 23 patients (22 with bacteremia and 1 with endocarditis), Dalbavancin was effective in clearing infections, with all 22 patients showing confirmed culture clearance and no reported side effects.

The results suggest that Dalbavancin could be a safe and effective outpatient treatment option for patients unable to undergo prolonged hospitalization, as there were no readmissions or deaths related to the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of dalbavancin in the treatment of gram positive blood stream infections: a case series. Evins, C., Lancaster, H., Schnee, AE.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dalbavancin. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Dalbavancin Use in Vulnerable Patients Receiving Outpatient Parenteral Antibiotic Therapy for Invasive Gram-Positive Infections. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Dalbavancin, a long-acting lipoglycopeptide for the treatment of multidrug-resistant Gram-positive bacteria. [2014]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dalbavancin: A Novel Lipoglycopeptide Antibiotic with Extended Activity Against Gram-Positive Infections. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Dalbavancin in clinical practice in Spain: a 2 year retrospective study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Multicentre, Prospective, and Retrospective Registry to Characterize the Use, Effectiveness, and Safety of Dalbavancin in German Clinical Practice. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Successful use of dalbavancin in the treatment of gram positive blood stream infections: a case series. [2022]