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 study about?

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.

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

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

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

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 Study?

  • Age between 3 months and 12 years old
  • 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)
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Klaipeda Children Hospital Klaipeda Lithuania
Spitalul Clinic De Urgenta Pentru Copii Brasov Brasov Romania

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hospital Universitario 12 De Octubre Madrid Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital Cuf Descobertas S.A. Lisbon Portugal
Daugavpils regionala slimnica SIA Daugavpils Latvia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
University Multiprofessional Hospital For Active Treatment Kanev AD Ruse Bulgaria
Hospital De Sao Francisco Xavier Lisbon Portugal
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara Timisoara Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Liepajas Regionala Slimnica SIA Liepaja Latvia
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD Lom Bulgaria
Blcen Kzswgshg Uixhyklimwbqk Sycafscy Vflc Riga Latvia
Fjlacofts Pnwt Lz Iqjjxahaxdfkj Bcekasruq Dbk Hfzzdsow Uabtiranlbjrq Ly Pbg Madrid Spain
Hbkpssih Vgxn dezmnkwy Barcelona Spain
Ufmekqqnym Gbwrvrt Hrjnjcri Acioxmb Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.06.2023
Greece Greece
Not recruiting
01.06.2023
Latvia Latvia
Not recruiting
01.06.2023
Lithuania Lithuania
Not recruiting
01.06.2023
Poland Poland
Not recruiting
01.06.2023
Portugal Portugal
Not recruiting
01.06.2023
Romania Romania
Not recruiting
01.06.2023
Spain Spain
Not recruiting
01.06.2023

Trial locations

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.

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.

Trial ID:
2024-516385-10-00
Protocol code:
ML-ORI-201
Trial Phase:
Therapeutic exploratory (Phase II)

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