NCT03019965

Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis

Efficacy and Safety of the Administration of Betalactam Antibiotics in Continuous or Extended Infusion Compared to Intermittent Infusion in Patients With Sepsis in Two Pediatric Third-level Care Hospitals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis. Half of participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or meropenem in intermittent infusion.

Detailed description

Sepsis is the leading cause of morbidity and mortality in hospitalised patients globally. Betalactams are time-dependent antibiotics, and so, the duration of time for which the free drug plasma concentration remains above the minimum inhibitory concentration (fT \> MIC) is the pharmacokinetic/pharmacodynamic index associated with bacterial killing and clinical improvement. Numerous studies have demonstrated that continuous infusion (infusion in 24 hours) and extended infusion (through prolonging the infusion time to greater than 3 hours) allows the maintenance of concentrations above the MIC for a longer period of time within the dosing interval (30 minute or 1 hour), and so, capitalises on the pharmacodynamic properties of betalactams and maximises bacterial killing, therefore potentially improving clinical outcomes. In adult patients, the several studies suggest that prolonged infusion may offer clinical benefits and significant reduction in mortality without increasing the risk of toxicity, however, there is limited information about these dosing strategies in pediatric patients.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	Intermittent Piperacillin/tazobactam	Piperacillin/tazobactam administered in 30 minutes infusion.
DRUG	Continuous Piperacillin/tazobactam	Piperacillin/tazobactam administered in 24 hours infusion.
DRUG	Intermittent Imipenem	Imipenem administered in 60 minutes infusion.
DRUG	Extended Imipenem	Imipenem administered in 6 hours infusion.
DRUG	Intermittent Meropenem	Meropenem administered in 60 minutes infusion.
DRUG	Extended Meropenem	Meropenem administered in 8 hours infusion.

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-12-30
• Completion: 2020-01-30
• First posted: 2017-01-13
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

2 sites across 1 country: Mexico