Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotic Duration in Post-appendectomy Abscess

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03795194
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital

Brief Summary:
This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.

Condition or disease Intervention/treatment Phase
Complicated Appendicitis Perforated Appendicitis Drug: ampicillin/clavulanate Phase 4

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
8-day
8-day course of ampicillin clavulanate antibiotic
Drug: ampicillin/clavulanate
FDA-approved antibiotic
Other Name: Augmentin

4-day
4--day course of ampicillin clavulanate antibiotic
Drug: ampicillin/clavulanate
FDA-approved antibiotic
Other Name: Augmentin




Primary Outcome Measures :
  1. Hospital readmission rate [ Time Frame: 30 days ]
    Number of times patient is readmitted to the hospital after their laparoscopy.

  2. 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.

  3. Rate of abdominal abscess [ Time Frame: 30 days ]
    Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 2 to 17 years of age
  • Diagnosis of perforated appendicitis at laparoscopy
  • Development of a post-appendectomy abscess that is treated with percutaneous drainage.

Exclusion Criteria:

  • Patients who are allergic to ampicillin

Layout table for additonal information
Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT03795194     History of Changes
Other Study ID Numbers: 17-055
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ampicillin
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action