Antibiotic Duration in Post-appendectomy Abscess

NCT03795194 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17-055
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Complicated Appendicitis; Perforated Appendicitis

Outcome Measures

Primary Outcomes (2)

• Hospital Readmission Rate

  Rate of readmission to the hospital after abscess drainage.

  30 days

• Length of Hospital Stay

  How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.

  30 days

Study Arms (2)

8-day

OTHER

8-day course of ampicillin clavulanate antibiotic

Drug: ampicillin/clavulanate

4-day

OTHER

4--day course of ampicillin clavulanate antibiotic

Drug: ampicillin/clavulanate

Interventions

ampicillin/clavulanate DRUG

FDA-approved antibiotic

Also known as: Augmentin

4-day; 8-day

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are allergic to ampicillin

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Ampicillin; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids; Amoxicillin; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Low enrollment. Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Research Coordinator
• Organization: Phoenix Children's

zhunteman@phoenixchildrens.com

6029331858

Study Officials

• Craig Egan, MD

  Phoenix Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: January 7, 2019
• Study Start: May 1, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)