N/A N=426 Randomized Treatment

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

Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT03019965 ↗

Enrolled (actual)

426

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Participants With Clinical Response — 178; 169 Participants — p=0.156

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intermittent Piperacillin/tazobactam (Drug); Continuous Piperacillin/tazobactam (Drug); Intermittent Imipenem (Drug); Extended Imipenem (Drug); Intermittent Meropenem (Drug); Extended Meropenem (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Coordinación de Investigación en Salud, Mexico
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Response	178; 169	0.156
SECONDARY Number of Participants With Adverse Events	1; 3	0.722

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03019965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.