Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.

The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.

The primary outcome variable between the two strategies is abscess rate.

Study Overview

• Status: Completed
• Conditions: Perforated Appendicitis
• Intervention / Treatment: Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole); Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)

Detailed Description

This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.

Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150.

Subjects will be those children who undergo a laparoscopic appendectomy as part of their routine care.

Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen.

The control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT Scan is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management.

The experimental group will receive the same combination of antibiotics while in the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance.

Given the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy

Exclusion Criteria:

• Known immune deficiency
• Abscess identified on pre-op imaging
• Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 5 days of IV antibiotics after appendectomy	Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole); 5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)
Experimental: 2; home on oral antibiotics to complete 7 days of treatment when tolerating PO's	Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid); Augmentin 40mg/kg BID when tolerating POs to complete 7 days total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Abscess After Appendectomy	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative Time	1 month
Time to Regular Diet	1 month
Length of Stay After Operation	1 month
Total Healthcare Visits	1 month

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Shawn D St. Peter, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: April 16, 2007
• First Submitted That Met QC Criteria: April 17, 2007
• First Posted (Estimate): April 18, 2007

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: appendicitis, perforation, abscess, treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; beta-Lactamase Inhibitors; Metronidazole; Ceftriaxone; Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids
• Other Study ID Numbers: 07 02 031