A MULTICENTER, OPEN-LABEL, EVALUATOR-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SINGLE-DOSE INTRAVENOUS ORITAVANCIN FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
This study is investigating a medicine called Oritavancin (you might hear it called ORBACTIV or KIMYRSA) to see how safe it is for children who have serious skin infections. These infections are often called Acute Bacterial Skin and Skin Structure Infections. Doctors want to find out if giving this medicine as a single dose, through a drip into a vein, causes any unwanted side effects in children. They will compare it to another common antibiotic, AZACTAM. The main goal is to carefully check for any safety concerns related to Oritavancin in this young age group, but they will also look at whether anyone passes away during the study.
At a glance
What is this study about?
This research study is about finding out more about a medicine called Oritavancin. It's also known by the brand names ORBACTIV and KIMYRSA. Doctors are testing it to see if it's a safe and useful treatment for children who have serious skin infections caused by bacteria. These types of infections can be quite painful and might need strong medicines to clear them up.
In this study, Oritavancin is given as a single dose, meaning just one treatment through a drip into a child's vein. Doctors will carefully compare it with another common antibiotic called AZACTAM. They want to make sure that Oritavancin is safe for children and doesn't cause too many problems. This is an early stage of study, often called Phase II, which means they are exploring how the medicine works in people, especially focusing on its safety.
The main thing researchers are looking at is how safe Oritavancin is for children. They will be watching very closely for any side effects or unwanted reactions. They will also keep track of whether any children pass away during the study. This helps them understand the overall safety of the medicine before it can be used more widely.
Key takeaways
- This study is testing a new antibiotic called Oritavancin (ORBACTIV/KIMYRSA) in children.
- It's for serious skin infections caused by bacteria.
- The main goal is to check how safe the new medicine is for children.
- Children will receive a single dose through a drip, either the new medicine or a standard one.
- The study is in an early stage (Phase II) of development.
- Parents can withdraw their child at any time.
Who may be eligible?
To join this study, children need to have bacterial skin and skin structure infections that are serious enough to require hospital treatment. The study is open to both boys and girls of all ages who have this type of infection. There are no specific age limits; it's open to children from infancy right up to teenage years.
However, there will be other specific medical reasons why a child might not be able to join. For example, if they have other serious health problems, are allergic to certain medicines, or are already taking other treatments that might interfere with the study medicine, they might not be eligible. These details would be discussed fully by the study doctors.
Ultimately, a doctor involved in the study would need to review your child's full medical history and current condition to decide if they are suitable to take part.
- Does your child have a bacterial skin infection that is serious?
- Is your child's doctor considering hospital treatment for this infection?
- Is your child currently not on any other medicines that might interfere with antibiotics?
- Does your child not have any known severe allergies to antibiotics?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they would receive either the study medicine, Oritavancin, or a standard medicine, AZACTAM, through a drip. They would receive just one dose. Your child would have regular check-ups with the study doctors and nurses. These visits would include physical examinations, blood tests, and probably check-ups on their infection to see how it's healing.
There will also be follow-up visits, even after your child's infection has cleared up, to make sure there are no delayed side effects. The study team will explain exactly how many visits are needed and what each visit involves. They will also let you know the total length of time your child will be involved in the study, from getting the medicine to the final follow-up appointment.
Potential risks and benefits
Locations (8)
- —Latvia
- —Romania
- —Greece
- —Portugal
- —Poland
- —Spain
- —Bulgaria
- —Lithuania
Common questions
What kind of infections is this study looking at?
It's for serious skin infections in children that are caused by bacteria and need strong medicine.
What is Oritavancin?
Oritavancin is a new antibiotic medicine that doctors are testing to see how well it works and how safe it is for children.
How is the medicine given?
It's given as a single dose through a drip into a vein, just once.
Will my child definitely get the new medicine?
Not necessarily. Children in the study will be given either Oritavancin or another common antibiotic, AZACTAM, by chance.
Can I take my child out of the study if I change my mind?
Yes, you can withdraw your child from the study at any time, and it won't affect their usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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