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

NCT03019965 | Completed Results DMC

• 1 other identifier: 2016-785-099
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response

  Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason).

  Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation.

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation.

Study Arms (6)

Intermittent Piperacillin/tazobactam

ACTIVE COMPARATOR

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.

Drug: Intermittent Piperacillin/tazobactam

Continuous Piperacillin/tazobactam

EXPERIMENTAL

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.

Drug: Continuous Piperacillin/tazobactam

Intermittent Imipenem

ACTIVE COMPARATOR

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.

Drug: Intermittent Imipenem

Extended Imipenem

EXPERIMENTAL

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.

Drug: Extended Imipenem

Intermittent Meropenem

ACTIVE COMPARATOR

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.

Drug: Intermittent Meropenem

Extended Meropenem

EXPERIMENTAL

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.

Drug: Extended Meropenem

Interventions

Intermittent Piperacillin/tazobactam DRUG

Piperacillin/tazobactam administered in 30 minutes infusion.

Also known as: Intermittent Infusion of Piperacillin/tazobactam, PiSA

Intermittent Piperacillin/tazobactam

Continuous Piperacillin/tazobactam DRUG

Piperacillin/tazobactam administered in 24 hours infusion.

Also known as: Continuous Infusion of Piperacillin/tazobactam, PiSA

Continuous Piperacillin/tazobactam

Intermittent Imipenem DRUG

Imipenem administered in 60 minutes infusion.

Also known as: Intermittent Infusion of Imipenem, PiSA

Intermittent Imipenem

Extended Imipenem DRUG

Imipenem administered in 6 hours infusion.

Also known as: Extended Infusion of Imipenem, PiSA

Extended Imipenem

Intermittent Meropenem DRUG

Meropenem administered in 60 minutes infusion.

Also known as: Intermittent Infusion of Meropenem, Kener, Merrem, AstraZeneca

Intermittent Meropenem

Extended Meropenem DRUG

Meropenem administered in 8 hours infusion.

Also known as: Extended Infusion of Meropenem, Kener, Merrem, AstraZeneca

Extended Meropenem

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator
• Hospital Infantil de Mexico Federico Gomez: collaborator
• Hospital Regional de Alta Especialidad del Bajio: collaborator

Study Sites (2)

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, 06720, Mexico

Location

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Sepsis

Interventions

Tazobactam; Meropenem

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thienamycins; Carbapenems

Results Point of Contact

• Title: Dr. Yazmín Fuentes
• Organization: CISMexico

yazmin_fuentes@hotmail.com

55276900

Study Officials

• Yazmín del Carmen Fuentes

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Infectious Disease

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 13, 2017
• Study Start: February 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)