drugset / Trial / NCT02724410

Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

NCT02724410 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Timeline

Start
2011-01
Primary completion
2013-11
Completion
2013-11

Outcome

Mixed primary results

registry COUNT_OF_PARTICIPANTS Home Intravenous Ertapenem and PICC: 5 Participants NCT02724410 ↗

registry COUNT_OF_PARTICIPANTS Home Oral Amoxicillin-clavulanate: 3 Participants NCT02724410 ↗

registry analysis (other test); Home Intravenous Ertapenem and PICC vs Home Oral Amoxicillin-clavulanate; p = 0.7188; Chi-squared NCT02724410 ↗

registry MEAN Home Intravenous Ertapenem and PICC: 47564.3 (Standard Deviation 9057.59) Dollars NCT02724410 ↗

registry MEAN Home Oral Amoxicillin-clavulanate: 34227.79 (Standard Deviation 8104.65) Dollars NCT02724410 ↗

registry analysis (other test); Home Intravenous Ertapenem and PICC vs Home Oral Amoxicillin-clavulanate; p <.0001; Wilcoxon (Mann-Whitney) NCT02724410 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin-clavulanate Other / unclassified 15 mg/kg Oral
Subject Amoxicillin-clavulanate Other / unclassified 22.5 mg/kg Oral
Comparator Ertapenem Small molecule 15 mg/kg Intravenous
Comparator Ertapenem Small molecule 1 g Intravenous

Indications