Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin I… (NCT05599295) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
United States, Bulgaria118 participantsStarted 2023-06-15
Plain-language summary
This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs).
This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).
The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.
Who can participate
Age range3 Months – 11 Years
SexALL
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Inclusion criteria
✓. Male or female, 3 months to \<12 years of age at randomization
✓. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen):
✓. Wound infection: that is either traumatic or surgical in origin, defined as an infection characterized by purulent drainage from a wound with surrounding erythema, edema, and/or induration
✓. Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration
✓. Major cutaneous abscess: an infection characterized by a collection of pus within the dermis or subcutaneous tissue that is accompanied by surrounding erythema, edema, and/or induration
✓. ABSSSI must present with at least 2 of the following signs and symptoms:
✓. Purulent drainage or discharge
✓. Erythema (\>1 centimeter beyond edge of wound or abscess)
Exclusion criteria
What they're measuring
1
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
. Participants who have received more than 72 hours of effective antibacterial drug therapy for treatment of the current episode of ABSSSI
✕. Participants who have received a glycopeptide antibiotic (for example, vancomycin, telavancin, teicoplanin) within 24 hours of randomization
✕. Participants who have received dalbavancin within 45 days prior to randomization
✕. Participants who have been treated with oritavancin within the last 50 days
✕. Participants with infection suspected to be associated with a device or implant
✕. Participants with septic shock or hemodynamic instability
✕. Participants with ABSSSI due to, or associated with any of the following:
✕. Infection suspected or documented to be caused predominantly by gram-negative pathogens (for example, human or animal bite, injury contaminated with fresh or saltwater, external malignant otitis), fungi, or viruses