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Study of single-dose oritavancin safety and tolerability in children with acute bacterial skin and skin structure infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The clinical trial investigates the use of oritavancin in treating Acute Bacterial Skin and Skin Structure Infections in children. This infection can appear as wound infections, skin infections with redness and swelling (cellulitis/erysipelas), or collections of pus under the skin (cutaneous abscess). The study will test two forms of the medication - ORBACTIV and KIMYRSA - which are given as a single dose through an intravenous infusion.

The main purpose of this research is to determine if these medications are safe and well-tolerated by children between 3 months and 12 years of age. During the study, children will receive either ORBACTIV or KIMYRSA as a single treatment. Some participants will also receive aztreonam, another antibiotic given by injection.

The study will track how children respond to the treatment and monitor for any side effects. Doctors will check for signs of infection improvement, such as reduction in skin redness, swelling, and warmth. They will also monitor the children's overall health status throughout the treatment period, which may last up to 14 days.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medical examination
Your doctor will check if you have a skin infection that qualifies for the study
The infection needs to show at least two symptoms: drainage, redness, swelling, warmth, or pain
You must also have one sign of inflammation such as swollen lymph nodes, fever, or specific blood test results
Step 2
Treatment administration
You will receive a single dose of oritavancin through an intravenous infusion (medicine given directly into a vein)
The medicine will be administered only once during the entire study
The medical staff will monitor you during and after the infusion
Step 3
Follow-up period
Your doctor will schedule regular check-ups to monitor your recovery
The medical team will assess how well the infection is healing
They will record any side effects you may experience
A final evaluation will be conducted at the Time of Cure visit
Step 4
Study completion
The study will end after your final evaluation
Your participation will help assess how safe and well-tolerated the medicine is in children

Who can join the trial?

17 criteria

Age between 3 months and 12 years old
check
Must have a diagnosed skin infection that is one of these types:
- Wound infection (from injury or surgery) with pus drainage and redness/swelling around it
- Cellulitis or erysipelas (spreading skin infection with redness and swelling)
- Major skin abscess (collection of pus under the skin with surrounding redness and swelling)
- check
  Must have at least two of these signs:
  - Pus drainage
  - Redness extending more than 1 cm from wound edge
  - Soft, fluid-filled swelling
  - Warmth in the area
  - Swelling or hardness
  - Pain when touched
  - Must have at least one of these signs of body-wide infection:
    
    Swollen and tender lymph nodes
    High fever (above 38.0°C/100.4°F)
    Low temperature (below 36.0°C/96.8°F)
    Abnormal white blood cell count (either below 4000 or above 12,000 per mm3)
    Elevated immature white blood cells (above 10%)
    Elevated C-reactive protein (a marker of inflammation)
    Parents or legal guardians must provide written consent, and when appropriate, child must provide verbal or written agreement to participate

Who cannot join the trial?

13 criteria

Patients younger than 3 months of age
Known allergy or hypersensitivity (severe allergic reaction) to oritavancin or similar antibiotics
Active endocarditis (infection of heart valves)
Severe kidney problems requiring dialysis
Severe liver disease
Currently participating in other clinical trials
Pregnant or breastfeeding women
Patients with osteomyelitis (bone infection) or septic arthritis (joint infection)
Known or suspected bloodstream infections
Use of other antibiotics within 24 hours before starting the study treatment
History of drug or alcohol abuse within the past year
Any condition that, in the investigator's opinion, would make participation unsafe
Unable to comply with study procedures or follow-up visits

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Oritavancin (also known as ORBACTIV and KIMYRSA) is an antibiotic medication given through an intravenous (IV) infusion. It is used to treat serious skin infections and skin structure infections caused by bacteria. This medication is special because it only needs to be given once as a single dose, unlike many other antibiotics that need to be taken multiple times. In this trial, it is being tested in children to see how safe it is and how well they tolerate it.

What is already known about the treatment

Oritavancin - An intravenous antibiotic medication administered as a single dose for treating acute bacterial skin and skin structure infections (ABSSSI). This medication belongs to the lipoglycopeptide class of antibiotics and works by interfering with bacterial cell wall synthesis, leading to bacterial cell death. Oritavancin is particularly notable for its unique single-dose administration protocol, which can improve patient compliance compared to multiple-dose antibiotics, and is marketed under the brand names ORBACTIV and KIMYRSA. The medication has been proven effective against various gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and is currently being studied in pediatric populations to establish its safety and efficacy in younger patients.

Investigated diseases

Acute Bacterial Skin and Skin Structure Infections - A type of infection that affects the skin and the tissues beneath it, developing over a short period. The condition typically causes redness, swelling, warmth, and tenderness in the affected area of skin. It can involve various parts of the body and may be accompanied by fever and general discomfort. The infection can spread to deeper layers of skin and surrounding soft tissues, causing the affected area to become increasingly painful and swollen. These infections can develop from small breaks in the skin, cuts, or other wounds that become infected with bacteria.