Overview

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

Status:
Completed

Trial end date:
2009-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

HaEmek Medical Center, Israel

Treatments:

Ampicillin
Ceftriaxone
Gentamicins
Metronidazole

Criteria

Inclusion Criteria:

- Children age 1-14 years CA that was defined by one of the followings:

1. Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of
appendix perforation and/or peri-appendicular abscess

2. Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse
peritoneal irritation in the right lower quadrant of the abdomen 3

Exclusion Criteria:

- Documented allergy to any of the study medications, acute or renal insufficiency at
admission, and severe septic shock at admission.