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NCT Number: NCT03019965

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

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.

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Key information

Conditions

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

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil de México Federico Gómez, Mexico City, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Piperacillin/tazobactam

Drug

Piperacillin/tazobactam administered in 30 minutes infusion.

Other names: Intermittent Infusion of Piperacillin/tazobactam, PiSA

Continuous Piperacillin/tazobactam

Drug

Piperacillin/tazobactam administered in 24 hours infusion.

Other names: Continuous Infusion of Piperacillin/tazobactam, PiSA

Intermittent Imipenem

Drug

Imipenem administered in 60 minutes infusion.

Other names: Intermittent Infusion of Imipenem, PiSA

Extended Imipenem

Drug

Imipenem administered in 6 hours infusion.

Other names: Extended Infusion of Imipenem, PiSA

Intermittent Meropenem

Drug

Meropenem administered in 60 minutes infusion.

Other names: Intermittent Infusion of Meropenem, Kener, Merrem, AstraZeneca

Extended Meropenem

Drug

Meropenem administered in 8 hours infusion.

Other names: Extended Infusion of Meropenem, Kener, Merrem, AstraZeneca

Primary outcomes

  1. Number of Participants With Clinical Response

    Time frame: 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.

    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).

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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.

    Any harmful, undesirable, potentially serious and life threatening effects occurring during or after administration of the antibiotics proposed in this study (piperacillin / tazobactam, imipenem or meropenem), was evaluated as: none or adverse event classified according to the intensity of the clinical manifestation (severity) as: mild, moderate or severe and for each antibiotic.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Hospital Infantil de Mexico Federico Gomez
  • Hospital Regional de Alta Especialidad del Bajio
  • Instituto Mexicano del Seguro Social

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 13, 2017
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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