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

NCT01678365 | Completed Phase 4 DMC

• 1 other identifier: 043-07-EMC
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complicated Appendicitis

Keywords

complicated appendicitis; Children; conservative therapy; Study population: Children 1 month - 14 years with Complicated appendicitis; Type of the study: prospective, open randomized

Outcome Measures

Primary Outcomes (2)

• Length of stay (days)

  From admission to discharge from of first admission (if there are more than one), an expected average 2 weeks

• Change of primary antibiotic regimen to Piperacillin/tazobactam

  From admission to discharge from of first admission (if there are more than one), an expected average 2 weeks

Secondary Outcomes (1)

• Number of new intrabdominal abcesses

  From admission to discharge from of first admission (if there are more than one), an expected average 2 weeks

Other Outcomes (1)

• Re hospitalization due to intra abdominal abcess formation

  Within 2 years after day of discharge

Study Arms (2)

ceftriaxone and metronidazole for complicated appendicitis.

EXPERIMENTAL

Children with complicated appendicitis treated with single daily dose of ceftriaxone and metronidazole.

Drug: ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole

Ampicillin, gentamicin, and metronidazole

ACTIVE COMPARATOR

Children with complicated appendicitis treated with ampicillin, gentamicin, and metronidazole

Drug: ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole

Interventions

ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole DRUG

Ampicillin, gentamicin, and metronidazole; ceftriaxone and metronidazole for complicated appendicitis.

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 1-14 years CA that was defined by one of the followings:
• Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess
• Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Pediatric Surgery Department, HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Interventions

Ceftriaxone; Metronidazole; Ampicillin; Gentamicins

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Penicillin G; Penicillins; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: September 5, 2012
• Study Start: July 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

IL (1)