Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

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.

Intervention(s) in this Clinical Trial

• Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole)
  • 5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)
• Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)
  • Augmentin 40mg/kg BID when tolerating POs to complete 7 days total

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 5 days of IV antibiotics after appendectomy
• Experimental: 2
  • home on oral antibiotics to complete 7 days of treatment when tolerating PO's

Primary Measures

• Abscess after appendectomy
  • Time Frame: 1 month
    

Secondary Measures

• Length of stay, charges, adverse events
  • Time Frame: 1 month
    

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Mercy Hospital Kansas City

Overall Clinical Trial Officials and Contacts

Shawn D St. Peter Principal Investigator Children's Mercy Hospital  

Overall Contact: Shawn D St. Peter, MD (816)234-3575 sspeter@cmh.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00462020

Study ID Number: 07 02 031

ClinicalTrials.gov Identifier: NCT00462020

Health Authority: United States: Institutional Review Board