One shot wonder? new antibiotic trial for Kids' skin infections
NCT ID NCT05599295
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a single dose of the antibiotic oritavancin in 118 children aged 3 months to 12 years with acute bacterial skin infections. The goal was to see if it is safe and tolerable. Researchers also looked at how the drug works in the body and whether it cures the infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oritavancin (antibiotic)
- What this could lead to
- If successful, this could provide a single-dose treatment option for children with bacterial skin infections, reducing the need for multiple doses.
- What could go wrong
- This is a phase 2 trial with only 118 participants, so results may not apply to all children. Side effects are possible, and the drug may not work as well as current treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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118 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 months to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, 3 months to \<12 years of age at randomization 2. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen): 1. 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 2. Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, edema, and/or induration 3. 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 3. ABSSSI must present with at least 2 of the following signs and symptoms: 1. Purulent drainage or discharge 2. Erythema (\>1 centimeter beyond edge of wound or abscess) 3. Fluctuance 4. Heat or localized warmth 5. Edema/induration 6. Pain or tenderness to palpation and at least 1 of the following signs of systemic inflammation: 1. Proximal lymph node swelling and tenderness 2. Increased temperature (\>38.0°C \[\>100.4°F\]) 3. Decreased temperature (\<36.0°C \[\<96.8°F\]) 4. Decreased white blood count (WBC) (\<4000/cubic millimeter \[mm\^3\]) or increased WBC (\>12,000 mm\^3) 5. Bandemia \>10% 6. C-reactive protein \>upper limit of normal (ULN) 4. Written informed consent obtained from parent(s) or legal guardian(s), with written or documented verbal assent of the child obtained, when appropriate, before initiation of any assessments conducted solely for study purposes Exclusion Criteria: 1. Participants who have received more than 72 hours of effective antibacterial drug therapy for treatment of the current episode of ABSSSI 2. Participants who have received a glycopeptide antibiotic (for example, vancomycin, telavancin, teicoplanin) within 24 hours of randomization 3. Participants who have received dalbavancin within 45 days prior to randomization 4. Participants who have been treated with oritavancin within the last 50 days 5. Participants with infection suspected to be associated with a device or implant 6. Participants with septic shock or hemodynamic instability 7. Participants with ABSSSI due to, or associated with any of the following: 1. 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 2. Wound infection (surgical or traumatic) or abscess with only gram-negative pathogens 3. Concomitant infection at another site, not including a secondary ABSSSI lesion (for example, septic arthritis, endocarditis, osteomyelitis). Secondary infections due to the same gram-positive bacteria are eligible to be enrolled in this study. 4. Infected burn 5. Primary infection superimposed on a pre-existing skin disease with associated inflammatory changes (for example, atopic dermatitis, eczema) 6. Any evolving necrotizing process (for example, necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by clostridioides species (for example, crepitance on examination of the ABSSSI site and/or surrounding tissue\[s\], radiographic evidence of subcutaneous gas in proximity to the infection) 7. Clinically significant viral infection (for example, influenza, Coronavirus Disease 2019) which, in the investigator's judgement, will impact the study clinical outcome assessments (for example, participant is febrile due to the viral infection) 8. Participants currently receiving chronic systemic immunosuppressive therapy 9. Participants with neutropenia, defined as absolute neutrophil count \<500 cells/mm\^3 10. Participants with severe renal impairment, defined as an estimated glomerular filtration rate \<30 milliliters/minute/1.73 meters squared, using the updated bedside Schwartz formula. For participants under 1 year of age, severe renal impairment is defined as serum creatinine ≥2 times the 97.5th percentile creatinine for age, converted to mg/deciliter or a requirement for dialysis. Participants under 1 year of age with renal impairment require consultation with the sponsor's medical monitor before enrollment. 11. Menstruating females with a positive result for the urine or serum human chorionic gonadotropin test administered at screening 12. Females of childbearing potential (and males with female partners of childbearing potential) unwilling to practice abstinence or use highly effective methods of contraception during the entire study period from the time of the first dose and until 50 days after the last dose of protocol-defined study medication. A list of acceptable methods of contraception is listed in the protocol. 13. Participants with a history of infusion-related immunoglobulin E-mediated allergic reaction or hypersensitivity reaction to glycopeptides (for example, vancomycin, telavancin, dalbavancin, oritavancin, teicoplanin) or any of their excipients 14. Participants who are taking heparin (other than heparin flush for line patency) or warfarin, and/or require anticoagulant monitoring (activated partial thromboplastin time, prothrombin time, international normalized ratio) 15. Participants receiving treatment with an investigational medicinal product or investigational device within 3 months before enrollment or during the study 16. Participants whom the investigator considers unlikely to adhere to the protocol, comply with investigational medicinal product (IMP) administration, or complete the clinical study (for example, unlikely to survive 28 days from initiation of IMP) 17. Participants with alanine aminotransferase or aspartate aminotransferase \>3\* ULN or total bilirubin ≥2\* ULN
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Attikon University General Hospital
Chaïdári, Attica, 124 62, Greece
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Brasov Children Clinical Hospital
Brasov, 500063, Romania
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Centro Hospitalar de Lisboa Ocidental, EPE - Hospital São Francisco Xavier
Lisbon, 1449-005, Portugal
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Children's Clinical University Hospital
Riga, LV-1004, Latvia
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Daugavpils Regional Hospital
Daugavpils, Daugavpils Aprinkis, LV-5417, Latvia
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Hippokratio General Hospital of Thessaloniki
Thessaloniki, 546 42, Greece
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Hospital Sant Joan de Deu - PIN
Barcelona, 8950, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
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Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
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Hospital de Cascais
Alcabideche, Lisbon District, 2755-009, Portugal
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Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Kaunas County, LT-50009, Lithuania
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Klaipeda Children Hospital
Klaipėda, Klaipėda County, 92140, Lithuania
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Louis Turcanu Emergency Clinical Hospital for Children
Timișoara, Timiș County, 300011, Romania
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Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, 5300, Bulgaria
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Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
Lom, Montana, 3600, Bulgaria
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Nationwide Children's Hospital
Columbus, Ohio, 43205-2664, United States
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Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
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Tampa General Hospital
Tampa, Florida, 33606, United States
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University Multiprofile Hospital For Active Treatment Kanev AD
Rousse, 7002, Bulgaria
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University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003, Bulgaria
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University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
Plovdiv, 4000, Bulgaria
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University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, 1606, Bulgaria