Dalbavancin for Bacterial Skin Infections

No longer recruiting at 137 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called dalbavancin, an antibiotic, to evaluate its safety and effectiveness in treating serious bacterial skin infections in children. The focus is on infections caused by certain bacteria, including MRSA, a type of staph resistant to some antibiotics. The study compares a single-dose and a two-dose treatment of dalbavancin with other common antibiotics. Children who may qualify have skin infections requiring hospital care, possibly with symptoms like fever or areas of skin redness and swelling. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new treatment option.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dalbavancin is generally safe for treating skin infections caused by certain bacteria. One study found that patients tolerate dalbavancin well, with few problems reported. Another study showed similar safety results in both children and adults, with no new safety issues identified.

Additionally, past research confirmed that dalbavancin did not cause any serious side effects. Only two minor side effects were reported, and they were not serious. Importantly, the FDA has approved dalbavancin for treating skin infections in both adults and children, indicating trust in its safety.

Overall, dalbavancin appears to be a safe choice for treating bacterial skin infections, with strong evidence supporting its use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Dalbavancin is unique because it offers a simplified dosing regimen for bacterial skin infections, potentially requiring just one or two doses, compared to the standard treatments that often need multiple doses over 10-14 days. This reduces the burden on patients and caregivers, making it easier to manage at home. Additionally, dalbavancin is administered intravenously, which could improve effectiveness and ensure the medication reaches the infection site quickly. Researchers are excited about its potential to streamline treatment and enhance patient compliance, especially in pediatric patients.

What evidence suggests that this trial's treatments could be effective for bacterial skin infections?

Studies have shown that dalbavancin effectively treats sudden bacterial skin infections. In this trial, participants will receive either a single-dose or a two-dose regimen of dalbavancin. Research indicates that patients who took dalbavancin experienced better outcomes and spent less time in the hospital compared to those who received other treatments. One study found that two doses of dalbavancin led to better results than a single dose. This suggests that dalbavancin can be a strong option for treating infections caused by certain bacteria, including hard-to-treat types like MRSA. Overall, dalbavancin has shown promising results in managing these skin infections. ^{3 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591112/

Safety and Efficacy of Dalbavancin in Real Life Retrospective analysis of a large monocentric case series of patients treated for skin/soft tissue and other difficult-to-treat infections.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0924857923000341

Retrospective effectiveness study of dalbavancin and other ... Patients with acute bacterial skin and skin-structure infections receiving dalbavancin had a reduced length of stay compared with patients receiving other ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04298463

Retrospective Effectiveness Study of Dalbavancin and ... The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32981375/

Acute Bacterial Skin and Skin-Structure Infections, efficacy ... In contrast, the global microbiological assessment results indicated a favorable outcome for two doses of dalbavancin compared to the single dose of dalbavancin ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMc1407925

Dalbavancin or Oritavancin for Skin Infections These randomized trials investigated the efficacy of oritavancin and dalbavancin in acute bacterial skin and skin-structure infections.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4735234/

Safety of Dalbavancin in the Treatment of Skin and Skin ... Dalbavancin exhibits a favorable overall safety profile for treatment of acute bacterial skin and skin structure infections due to Gram-positive bacteria.

7. journals.lww.com journals.lww.com/pidj/fulltext/2023/03000/the_safety_and_efficacy_of_dalbavancin_and_active.6.aspx

The Safety and Efficacy of Dalbavancin and Active... The safety profile of dalbavancin was consistent in children and adults with ABSSSI. No new safety signals were identified.

8. rxabbvie.com rxabbvie.com/pdf/dalvance_pi.pdf

Dalvance - master-uspi-dalbavancin - 1-22-25 DALVANCE® is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01431339

NCT01431339 | Efficacy and Safety of Dalbavancin for the ... A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid)