Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00462020
First received: April 16, 2007
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Abscess After Appendectomy [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of Stay, Charges, Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462020

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

No publications provided

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
Study First Received: April 16, 2007
Results First Received: December 12, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Ceftriaxone
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014