Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462020
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2007-04-16
Brief Title:
Intravenous Versus IntravenousOral Antibiotics for Perforated Appendicitis
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Intravenous Versus IntravenousOral Antibiotics for Perforated Appendicitis
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 018 with alpha of 005 and power of 08 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 50mgkg once a day maximum dose 2 grams and metronidazole 30mgkg 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 ampicillinclavulanic acid Augmentin Augmentin dose will be 40mgkg 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
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 018 with alpha of 005 and power of 08 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 50mgkg once a day maximum dose 2 grams and metronidazole 30mgkg 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 ampicillinclavulanic acid Augmentin Augmentin dose will be 40mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None