drugset / Trial / NCT01678365

Safety and Efficacy of Single Daily Dose of Ceftriaxone and Metronidazole for Treatment of Complicated Appendicitis in Children

NCT01678365

Phase 4 Completed 43 enrolled HaEmek Medical Center, Israel
RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009. Included were children younger than 14 years with Complicated appendicitis randomly assigned either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin, and Metronidazole. The outcome variables compared were: maximum daily temperatures, overall duration of fever, time return to oral intake, length of antibiotic therapy, results of repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess drainage, Length of stay and adverse reaction.

Timeline

Start
2008-07
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ampicillin Unknown
Subject Ceftriaxone Other / unclassified
Subject Gentamicin Small molecule
Background Metronidazole Small molecule

Indications