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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis

NCT03280147

Infant, Newborn Neonatal SEPSIS Anti-bacterial Agents +1 more

COMPLETED PHASE3

Pharmacokinetics and Pharmacodynamics of Ceftazidime in Pediatric ICU Patients

NCT03133910

Sepsis

UNKNOWN

Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit

NCT03440918

Sepsis Procalcitonin Antimicrobial Stewardship

COMPLETED NA

Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children

NCT04794595

Sepsis Children, Only

RECRUITING

Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children

NCT03441126

Sepsis Bacteremia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent Piperacillin/tazobactam

Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours.

Group Type ACTIVE_COMPARATOR

Intermittent Piperacillin/tazobactam

Intervention Type DRUG

Piperacillin/tazobactam administered in 30 minutes infusion.

Continuous Piperacillin/tazobactam

Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature.

Group Type EXPERIMENTAL

Continuous Piperacillin/tazobactam

Intervention Type DRUG

Piperacillin/tazobactam administered in 24 hours infusion.

Intermittent Imipenem

Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours.

Group Type ACTIVE_COMPARATOR

Intermittent Imipenem

Intervention Type DRUG

Imipenem administered in 60 minutes infusion.

Extended Imipenem

Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature.

Group Type EXPERIMENTAL

Extended Imipenem

Intervention Type DRUG

Imipenem administered in 6 hours infusion.

Intermittent Meropenem

Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours.

Group Type ACTIVE_COMPARATOR

Intermittent Meropenem

Intervention Type DRUG

Meropenem administered in 60 minutes infusion.

Extended Meropenem

Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature.

Group Type EXPERIMENTAL

Extended Meropenem

Intervention Type DRUG

Meropenem administered in 8 hours infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermittent Piperacillin/tazobactam

Piperacillin/tazobactam administered in 30 minutes infusion.

Intervention Type DRUG

Continuous Piperacillin/tazobactam

Piperacillin/tazobactam administered in 24 hours infusion.

Intervention Type DRUG

Intermittent Imipenem

Imipenem administered in 60 minutes infusion.

Intervention Type DRUG

Extended Imipenem

Imipenem administered in 6 hours infusion.

Intervention Type DRUG

Intermittent Meropenem

Meropenem administered in 60 minutes infusion.

Intervention Type DRUG

Extended Meropenem

Meropenem administered in 8 hours infusion.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intermittent Infusion of Piperacillin/tazobactam PiSA Continuous Infusion of Piperacillin/tazobactam PiSA Intermittent Infusion of Imipenem PiSA Extended Infusion of Imipenem PiSA Intermittent Infusion of Meropenem Kener Merrem, AstraZeneca Extended Infusion of Meropenem Kener Merrem, AstraZeneca

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients diagnosed with sepsis, who have been evaluated by an infectious physician and are candidates to receive piperacillin/tazobactam, imipenem or meropenem as empiric treatment.

Exclusion Criteria

* Patients with a history of allergy to one or more of the proposed antibiotics.
* Patients with chronic kidney disease or acute renal failure.
* Patients with acute liver failure of any cause.
* Patients in palliative or supportive care only.

Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No