N/A
Completed N=426
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
Source: ClinicalTrials.gov NCT03019965 ↗Enrolled (actual)
426
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With Clinical Response — 178; 169 Participants — p=0.156
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.
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 |
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.
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. Informational only — not medical advice.