Oritavancin for Skin Infections

No longer recruiting at 33 trial locations

Overseen By Sandra George

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Melinta Therapeutics, Inc.

Must not be taking: Glycopeptides, Dalbavancin, Heparin, Warfarin

Disqualifiers: Septic shock, Neutropenia, Renal impairment, others

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Single dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two formulations of oritavancin, Orbactiv and Kimyrsa, to treat children with acute bacterial skin infections, such as cellulitis and abscesses. The goal is to assess the safety and tolerability of these treatments. Children with skin infections showing symptoms like pain, swelling, or warmth might be suitable candidates. The study aims to gather important information while minimizing disruption to participants and their families. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken certain antibiotics recently or are on specific medications like heparin or warfarin. It's best to discuss your current medications with the study team to see if they might affect your eligibility.

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

Research has shown that oritavancin, the main ingredient in both Orbactiv and Kimyrsa, is generally safe for treating skin infections. Earlier studies indicated that oritavancin had a safety record similar to traditional treatments like vancomycin, meaning patients did not experience more side effects than those using standard treatments.

In real-world use, where oritavancin was administered outside controlled studies, patients did not experience higher rates of hospital readmission due to side effects. Additionally, the FDA has approved oritavancin for treating skin infections, supporting its safety.

Overall, both Orbactiv and Kimyrsa have safety data supporting their use for skin infections, with similar side effect profiles. Most patients tolerate the treatment well, with only a few experiencing mild to moderate side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Oritavancin treatments for skin infections because they offer a unique advantage over traditional antibiotics like vancomycin and daptomycin. Oritavancin, under the brand names Orbactiv and Kimyrsa, is infused at 15 mg/kg over just three hours, potentially reducing the treatment duration and hospital stays compared to the standard multi-dose regimens. Additionally, Oritavancin has a distinctive mechanism of action, disrupting bacterial cell membranes and inhibiting cell wall synthesis, which could enhance its effectiveness against resistant bacteria. This combination of a simplified dosing schedule and potent action against tough infections makes Oritavancin an exciting option for treating skin infections.

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

Research has shown that oritavancin effectively treats skin infections. In studies, a single dose of oritavancin, such as Orbactiv, matched the effectiveness of vancomycin taken twice daily for 7 to 10 days. This indicates that oritavancin can treat infections effectively with just one dose. In this trial, participants will receive either Orbactiv or Kimyrsa, both of which have demonstrated a reduced likelihood of hospital readmission and fewer medication-related side effects. Overall, oritavancin has proven to be a strong option for treating serious bacterial skin infections. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 3 months to under 18 years with certain bacterial skin infections. They must have symptoms like wound infection, cellulitis, or abscesses caused by gram-positive bacteria. Kids can't join if they've had extensive prior antibiotic treatment, severe kidney issues, allergic reactions to similar drugs, are on blood thinners or immunosuppressants, or have certain viral infections.

Inclusion Criteria

I have a serious skin infection like a wound, cellulitis, or a large abscess.

I have at least two symptoms of a severe skin infection.

Written informed consent obtained from parent(s) or legal guardian(s), with written or documented verbal assent of the child obtained, when appropriate, before initiation of any assessments conducted solely for study purposes

Exclusion Criteria

I am willing to use two forms of birth control or practice abstinence during the study.

I have been treated with antibiotics for a skin infection for more than 72 hours.

I have taken a glycopeptide antibiotic within the last 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single-dose intravenous (IV) oritavancin or standard of care antibiotics for the treatment of acute bacterial skin and skin structure infections

Single dose

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical outcome assessments at End of Treatment and Test of Cure visits

28 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oritavancin

Trial Overview The study tests the safety of a single IV dose of Oritavancin (found in ORBACTIV and KIMYRSA) against standard antibiotics for treating pediatric acute bacterial skin infections. It's an open-label study that includes pharmacokinetic sampling and clinical outcome assessments.

How Is the Trial Designed?

Group I: Orbactiv Experimental Treatment 1 Intervention

Orbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg.

Group II: Kimyrsa Experimental Treatment 1 Intervention

Kimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg.

Oritavancin is already approved in United States, European Union for the following indications:

Approved in United States as Orbactiv/Kimyrsa for:

• Acute bacterial skin and skin structure infections

Approved in European Union as Orbactiv/Kimyrsa for:

• Acute bacterial skin and skin structure infections

Who Is Running the Clinical Trial?

Melinta Therapeutics, Inc.

Lead Sponsor

Trials

36

Recruited

9,600+

Melinta Therapeutics, LLC

Lead Sponsor

Trials

3

Recruited

250+

Published Research Related to This Trial

Oritavancin, a second-generation lipoglycopeptide, has been shown to be as effective as vancomycin in treating Acute Bacterial Skin and Skin Structure Infections caused by Gram-positive bacteria, including MRSA, with a similar safety profile.

The main advantage of oritavancin is its single-dose administration and no need for plasma level monitoring, which could facilitate outpatient treatment, although its cost-effectiveness compared to other treatments remains to be fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of oritavancin for the treatment of acute bacterial skin and skin structure infections. García Robles, AA., López Briz, E., Fraga Fuentes, MD., et al.[2019]

Oritavancin is a powerful new antibiotic effective against serious Gram-positive infections, including methicillin-resistant Staphylococcus aureus, with a unique ability to work through multiple mechanisms of action.

It has a long half-life that may allow for infrequent dosing, potentially enabling treatment with just a single dose, while also demonstrating documented clinical efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oritavancin for skin infections. Anderson, DL.[2018]

In a study of 17 patients receiving multiple doses of oritavancin for complicated infections, all patients achieved clinical success or improvement, indicating its efficacy in treating serious infections like osteomyelitis and pneumonia.

While 24% of patients experienced adverse events that required discontinuation of oritavancin, these events were reversible, suggesting that oritavancin may be a safe alternative to traditional daily antibiotic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple-Dose Oritavancin Evaluation in a Retrospective Cohort of Patients with Complicated Infections. Schulz, LT., Dworkin, E., Dela-Pena, J., et al.[2018]

Oritavancin demonstrated high efficacy against Gram-positive pathogens responsible for skin and soft-tissue infections, with 98.8% of tested isolates being susceptible, including low MIC values for Staphylococcus aureus and various Streptococcus species.

Even against vancomycin-resistant Enterococcus faecalis, oritavancin was effective, inhibiting all strains at concentrations ≤0.5 mg/L, indicating its potential as a treatment option for resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of oritavancin against Gram-positive clinical isolates responsible for documented skin and soft-tissue infections in European and US hospitals (2010-13). Mendes, RE., Farrell, DJ., Sader, HS., et al.[2018]

Oritavancin is a new-generation lipoglycopeptide antibiotic specifically designed to treat acute bacterial skin and skin structure infections.

It offers a novel treatment option that may improve patient outcomes due to its unique mechanism of action against resistant bacterial strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oritavancin (Orbactiv): A New-Generation Lipoglycopeptide for the Treatment Of Acute Bacterial Skin and Skin Structure Infections. Rosenthal, S., Decano, AG., Bandali, A., et al.[2020]

Oritavancin is a lipoglycopeptide antibiotic specifically designed for treating acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria, and it was first approved in the US in August 2014.

The development of oritavancin represents a significant advancement in antibacterial treatments, providing a single-dose option for patients with ABSSSI, which simplifies treatment regimens and may improve patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oritavancin: first global approval. Markham, A.[2021]

Oritavancin, a single-dose IV therapy, was shown to be effective in treating acute bacterial skin infections, with only 6.1% of patients requiring hospitalization within 30 days after outpatient treatment, indicating its potential to reduce hospital admissions.

In a cohort of patients discharged from hospitals, the 30-day readmission rate was low at 6.6%, with only 2.6% related to infections, suggesting that oritavancin can safely facilitate early discharge for patients with skin and soft tissue infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Real-World Economic and Clinical Management of Adult Patients with Skin and Soft Tissue Infections (SSTIs) with Oritavancin: Data from Two Multicenter Observational Cohort Studies. Estrada, S., Lodise, TP., Tillotson, GS., et al.[2020]

Oritavancin is effective against a wide range of Gram-positive bacteria, including multidrug-resistant strains, with comparable or lower minimum inhibitory concentrations (MICs) than vancomycin and daptomycin, indicating its potential as a strong treatment option for acute bacterial skin infections.

In a study involving over 11,000 clinical isolates from 2011 to 2014, oritavancin showed equivalent in vitro activity against both meticillin-resistant and meticillin-susceptible Staphylococcus aureus, demonstrating its efficacy across different bacterial strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro activity of oritavancin and comparator agents against staphylococci, streptococci and enterococci from clinical infections in Europe and North America, 2011-2014. Biedenbach, DJ., Arhin, FF., Moeck, G., et al.[2018]

Citations

1. kimyrsa.com kimyrsa.com/real-world-data/

Real-World Data A retrospective real-world study of readmission rates of patients treated in the outpatient setting with oritavancin for SSTI, including MRSA.

2. link.springer.com link.springer.com/article/10.1007/s40267-021-00888-1

Oritavancin (KIMYRSA™) in acute bacterial skin and ... Oritavancin is the first single-dose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with ABSSSIs.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25803197/

Oritavancin for acute bacterial skin and skin structure infections Animal models have also shown promising results with oritavancin for other disease states including those that require long courses of i.v.. Areas covered: This ...

4. kimyrsa.com kimyrsa.com/clinical-studies/

Clinical Study Data Learn about studies for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). View full Prescribing Information for KIMYRSA® ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213716521001120

Review Efficacy and safety of oritavancin for the treatment ... ORI was not inferior to comparators for the treatment of ABSSSIs. Meanwhile, it showed advantages in reducing the rate of readmission and drug-related AEs.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214155s001lbl.pdf

KIMYRSA (oritavancin) for injection, for intravenous use KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused.

7. kimyrsa.com kimyrsa.com/

1-Hour ABSSSI Therapy With KIMYRSA™ (oritavancin) KIMYRSA™ is a single-dose 1-hour infusion treatment for ABSSSI including cellulitis, abscesses, and wound infections. For US health care professionals.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03873987

Relative Exposure and Safety Study of Kimyrsa in ABSSSI ... This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4580226/

Oritavancin for acute bacterial skin and skin structure ... ***This is a Phase 3 pivital clinical trial confirming results of SOLO I and contributing further pateint safety data that led to oritavancin's FDA approval for ...