Skin bacterial infection Trials in Disease

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

This clinical trial is investigating whether a single-dose antibiotic treatment called oritavancin is safe and well-tolerated in children with acute bacterial skin infections. These infections can appear as wound infections, skin infections with redness and swelling, or collections of pus under the skin.

Main inclusion criteria: The trial is open to children between 3 months and 12 years old who have been diagnosed with one of the following types of skin infections: wound infection with pus drainage and surrounding redness or swelling, cellulitis or erysipelas (spreading skin infection), or major skin abscess. Children must show at least two local signs of infection, such as pus drainage, redness extending more than 1 cm from the wound edge, soft swelling, warmth, hardness, or pain when touched. Additionally, they must have at least one sign that the infection is affecting the whole body, such as swollen lymph nodes, fever above 38.0°C, low temperature below 36.0°C, abnormal white blood cell count, elevated immature white blood cells, or elevated C-reactive protein. Parents or legal guardians must provide written consent, and when appropriate, the child must agree to participate.

Main exclusion criteria: The trial cannot include children younger than 3 months, those with known allergies to oritavancin or similar antibiotics, or those with active heart valve infections. Children with severe kidney problems requiring dialysis, severe liver disease, bone infections, joint infections, or known bloodstream infections are also excluded. Patients who have used other antibiotics within 24 hours before the study treatment, are participating in other clinical trials, or have conditions that would make participation unsafe cannot join. Pregnant or breastfeeding women, and those with a history of drug or alcohol abuse within the past year are also excluded.

Focus and goal: The main purpose of this research is to determine whether oritavancin is safe and well-tolerated by children in this age group. During the study, children will receive either ORBACTIV or KIMYRSA (two forms of oritavancin) as a single treatment given through an intravenous infusion. Some participants may also receive aztreonam, another antibiotic given by injection. Doctors will monitor how children respond to the treatment, track any side effects, and check for signs of infection improvement such as reduction in skin redness, swelling, and warmth. The medical team will conduct regular follow-up visits to assess recovery and overall health status throughout the treatment period, which may last up to 14 days.

Investigational drug: Oritavancin, marketed under the brand names ORBACTIV and KIMYRSA, is an antibiotic medication given through an intravenous infusion. It is designed to treat serious bacterial skin infections and is unique because it only needs to be given once as a single dose, unlike many other antibiotics that require multiple administrations. Oritavancin belongs to a class of antibiotics called lipoglycopeptides and works by disrupting bacterial cell wall formation, which leads to the death of the bacteria. This medication has been proven effective against various types of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and is now being studied in children to establish its safety and effectiveness in younger patients.