Oritavancin for Bacterial Infections in Children

Recruiting at 5 trial locations

Overseen By William Waverczak, MS

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Melinta Therapeutics, LLC

Must be taking: Antibiotics

Must not be taking: Glycopeptides

Disqualifiers: Septic shock, Pregnancy, Major organ disease, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 14 days

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this Phase 1 trial is to evaluate the pharmacokinetics, safety and tolerability of oritavancin in patients \<18 years old with a confirmed or suspected bacterial infection.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain antibiotics like vancomycin, telavancin, or teicoplanin within 24 hours before the trial or need them within 48 hours after. If you've taken dalbavancin, it must not have been within the last 2 weeks.

Is oritavancin safe for use in humans?

Oritavancin has been approved for treating skin infections in adults, indicating it has been evaluated for safety in humans. However, specific safety data for children is not provided in the available research. ^{1 2 3 4 5}

How is the drug oritavancin unique for treating bacterial infections in children?

Oritavancin is unique because it can be given as a single dose due to its long half-life, and it works by multiple mechanisms to kill bacteria, including stopping cell wall formation and disrupting the cell membrane. This makes it effective against a wide range of Gram-positive bacteria, including those resistant to other antibiotics. ^{1 2 3 6 7}

What data supports the effectiveness of the drug Oritavancin for bacterial infections in children?

Oritavancin has been shown to be effective in treating skin infections caused by certain bacteria, including resistant strains like MRSA, in adults. It works by killing bacteria and has been approved for use in treating skin infections in the US. While specific data for children is not provided, its success in adults suggests potential effectiveness in pediatric cases. ^{2 3 4 5 8}

Who Is on the Research Team?

Study Director

Principal Investigator

Melinta Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for children under 18 with suspected or confirmed Gram-positive bacterial infections. Neonates must be at least 34 weeks post-conception age. Participants need IV access and will stay in the hospital for observation after receiving the drug. Those with septic shock, hypersensitivity to similar drugs, recent use of certain antibiotics, or females who are pregnant/lactating or not using contraception are excluded.

Inclusion Criteria

Parent or legal guardian has given informed consent, as appropriate; and pediatric patient has given verbal assent where appropriate.

My baby was born at or after 34 weeks of pregnancy.

I will stay in the hospital for at least 1 hour after getting the study drug.

Exclusion Criteria

You have had a bad allergic reaction to certain medications called glycopeptides in the past.

I am a woman able to have children and will use two forms of birth control or abstain.

I agree to use birth control or practice abstinence during the study.

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 IV infusion of oritavancin and are monitored for pharmacokinetics and safety

14 days

3 PK sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 60-day follow-up call

60 days

What Are the Treatments Tested in This Trial?

Interventions

• Oritavancin

Trial Overview The study tests Oritavancin's effects on pediatric patients with bacterial infections. It aims to understand how the body processes this drug (pharmacokinetics), its safety, and tolerability when given to kids and teenagers as either a treatment for infection or as a preventive measure during surgery.

How Is the Trial Designed?

Group I: Oritavancin Experimental Treatment 1 Intervention

Single-Dose IV Oritavancin Diphosphate

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, LLC

Lead Sponsor

Trials

3

Recruited

250+

Melinta Therapeutics, Inc.

Lead Sponsor

Trials

36

Recruited

9,600+

Published Research Related to This Trial

Oritavancin is a promising antibiotic that shows rapid and effective action against a wide range of Gram-positive bacteria, including resistant strains, and has demonstrated efficacy in two Phase III trials for complicated skin infections, meeting the primary endpoint of clinical cure.

The drug's pharmacokinetic profile allows for a potential single-dose regimen, with advantages such as shorter treatment duration and fewer adverse events compared to traditional therapies, making it a strong candidate for treating serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oritavancin: a novel lipoglycopeptide active against Gram-positive pathogens including multiresistant strains. Bouza, E., Burillo, A.[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 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 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]

Oritavancin is a promising new antibiotic that shows strong effectiveness against various Gram-positive bacteria, including MRSA, with a single 1200 mg dose expected to be effective in humans based on animal studies.

The drug's unique pharmacokinetics, including extensive tissue distribution and a long half-life, support its potential for once-daily intravenous administration, making it a convenient treatment option for serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo activity of oritavancin in animal infection models and rationale for a new dosing regimen in humans. Ambrose, PG., Drusano, GL., Craig, WA.[2018]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Oritavancin: a novel lipoglycopeptide active against Gram-positive pathogens including multiresistant strains. [2020]

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

Oritavancin: first global approval. [2021]

3. Switzerland 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Oritavancin (Orbactiv): A New-Generation Lipoglycopeptide for the Treatment Of Acute Bacterial Skin and Skin Structure Infections. [2020]

5. Netherlands 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

In vivo activity of oritavancin in animal infection models and rationale for a new dosing regimen in humans. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

Oritavancin for skin infections. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Multiple-Dose Oritavancin Evaluation in a Retrospective Cohort of Patients with Complicated Infections. [2018]