Oritavancin for Bacterial Infections in Children

Not currently recruiting at 11 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called oritavancin, an antibiotic, for children with bacterial infections. As a Phase 1 trial, researchers aim to understand how the drug moves in the body and assess its safety and tolerability. Children and teens under 18 with a suspected or diagnosed bacterial infection, who are already receiving antibiotics, might qualify. The trial involves administering a single dose of the treatment through an IV and monitoring patients for a short period afterward. Participants should not have severe conditions like septic shock or allergies to similar antibiotics. Being a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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 there any evidence suggesting that oritavancin is likely to be safe for children?

In a previous study, researchers examined the safety of oritavancin for children. An independent safety board reviewed the data at each stage to ensure progress before proceeding. However, the research did not provide specific safety details for children.

The FDA has approved oritavancin for treating certain bacterial infections in adults, suggesting general safety. However, this does not guarantee safety for children. This trial aims to test the treatment's safety for younger patients, assessing their response and any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Oritavancin is unique because it offers a single-dose intravenous option for treating bacterial infections in children, which is a departure from the multiple-dose regimens typically required with standard antibiotics. This new approach could simplify treatment, making it easier for both healthcare providers and patients, especially in pediatric cases where adherence to complex dosing schedules is challenging. Additionally, oritavancin has a long-acting effect, potentially reducing the duration of the infection and the need for frequent hospital visits. Researchers are excited about its potential to streamline and improve treatment outcomes for young patients.

What evidence suggests that oritavancin might be an effective treatment for bacterial infections in children?

Research has shown that oritavancin effectively treats certain bacterial infections, including serious skin infections. Studies have demonstrated its safety and effectiveness, with only 6.6% of patients needing to return to the hospital within 30 days of discharge. Of these returns, just 2.6% were due to infections, indicating that oritavancin helps prevent further issues. This trial will evaluate the effectiveness of oritavancin in children, as it is already approved for treating specific bacterial infections in adults. The encouraging data highlight oritavancin as a strong option for treating bacterial infections. ^{2 4 6 7 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 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 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 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 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, 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05599295

Study to Evaluate the Safety of Intravenous Oritavancin for ... The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05599295/study-to-evaluate-the-safety-and-tolerability-of-single-dose-intravenous-iv-oritavancin

Study to Evaluate the Safety of Intravenous Oritavancin for ... This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8982769/

Kimyrsa, An Oritavancin-Containing Product: Clinical Study ... Oritavancin is approved for the treatment of Gram-positive infections, including ABSSSIs. Studies have also demonstrated the efficacy and safety of oritavancin ...

4. mountsinai.org mountsinai.org/clinical-trials/study-to-evaluate-safety-tolerability-of-single-dose-intravenous-iv-oritavancin

Study to Evaluate the Safety of Intravenous Oritavancin for ... Summary: This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) ...

5. withpower.com withpower.com/trial/phase-1-gram-positive-bacterial-infections-4-2014-0b026

Oritavancin for Bacterial Infections in Children 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 ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/214155s005lbl.pdf

KIMYRSA® (oritavancin) for injection, for intravenous use Patients should be counseled that antibacterial drugs including KIMYRSA should only be used to treat bacterial infections. They do not treat viral infections ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6252426/

1719. Pharmacokinetics (PK) of Oritavancin in Children An independent data safety monitoring board evaluated the safety and PK data of each cohort prior to dosing the subsequent cohort. Results.

8. 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.