Antibiotic Duration in Post-appendectomy Abscess
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|ClinicalTrials.gov Identifier: NCT03795194|
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Complicated Appendicitis Perforated Appendicitis||Drug: ampicillin/clavulanate||Phase 4|
The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge.
This study includes patients ages 2-17 years old who present with perforated appendicitis—as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen—and who develop an abscess after laparoscopy that is treated with percutaneous drainage.
All post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital—IV ceftriaxone/metronidazole—until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile.
At discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
8-day course of ampicillin clavulanate antibiotic
Other Name: Augmentin
4--day course of ampicillin clavulanate antibiotic
Other Name: Augmentin
- Hospital readmission rate [ Time Frame: 30 days ]Number of times patient is readmitted to the hospital after their laparoscopy.
- Length of hospital stay [ Time Frame: 30 days ]How many days patient stays in the hospital if and when they are readmitted after their laparoscopy.
- Rate of abdominal abscess [ Time Frame: 30 days ]Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.
- Rate of intra-abdominal wound infection [ Time Frame: 30 days ]How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.