Efficacy, Safety, and Cost-Efficiency of Continuous Antibiotic Infusion of Vancomycin and Combination Therapy for Infectious Diseases in Pediatric Patients

The primary objective is to evaluate the efficacy, safety, and pharmacoeconomics of continuous antibiotic infusion over a 24-hour period in pediatric patients with infectious disease. Secondary objectives include:

• Assessment of the perceived quality of life for children and parents using a validated questionnaire.
• Evaluation of intravenous route complications.

The sponsor did not provide information regarding the total number of participants. The study population consists of pediatric patients, specifically those within the age range associated with code 2, including both males and females. The subjects are identified as a vulnerable population diagnosed with an infectious disease. Inclusion requires that the patients are clinically stable and necessitate intravenous antibiotic treatment. Eligible participants must not require hospitalization and must be able to utilize a pump or cassette for administration at either a hospital or home setting. Additionally, the continuous antibiotic infusion must have been initiated no more than 24 hours prior to enrollment, and no allergy to the specific antibiotic is permitted.

This Phase III clinical trial is designed to evaluate the efficacy, safety, and cost-efficiency of continuous antibiotic infusion in pediatric patients with an infectious disease. The study involves the administration of various antibiotics via intravenous infusion, including cloxacillin, benzylpenicillin sodium, piperacillin/tazobactam, and vancomycin hydrochloride. The research methodology aims to assess primary endpoints such as the duration of hospital stay, fever, and antibiotic treatment, as well as hospital readmission and potential relapse. Inclusion requires that intravenous antibiotic treatment is necessary, the patient is clinically stable, and the diagnosis is certain. Participation is restricted to patients who have not yet started continuous infusion or have initiated it within the previous 24 hours. The recruitment period is estimated to occur between February 2026 and December 2030.

The investigational treatment involves the administration of cloxacillin provided as a solution for injection/infusion. The total dose is 12 g, administered via intravenous infusion.

Benzylpenicillin sodium is administered as a solution for injection/infusion at a dose of 20,000,000 IU through intravenous infusion.

The combination of piperacillin and tazobactam is utilized as a solution for infusion. The total dose is 12 g, delivered by intravenous infusion.

Vancomycin hydrochloride is administered as a solution for infusion at a dose of 3 g via intravenous infusion.

The study evaluates the efficacy and safety of continuous infusion over a 24-hour period.

The efficacy of continuous antibiotic infusion in pediatric patients with infectious disease is evaluated through several primary endpoints. These include the duration of hospital stay, the duration of fever, and the duration of antibiotic treatment. Additionally, the rate of hospital readmission and the occurrence of relapse, which is defined on an individual case basis, are assessed.