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Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT00462020
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted :
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Perforated Appendicitis 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 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Study Start Date : March 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Abscess After Appendectomy [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Length of Stay, Charges, Adverse Events [ Time Frame: 1 month ]

Eligibility Criteria

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462020

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Shawn D St. Peter Children's Mercy Hospital
More Information

Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00462020     History of Changes
Other Study ID Numbers: 07 02 031
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
appendicitis, perforation, abscess, treatment

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors