Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00462020 |
| Other study ID # |
07 02 031 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2007 |
| Est. completion date |
November 2008 |
Study information
| Verified date |
February 2021 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
