Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

NCT02724410 | Completed Results DMC

• 1 other identifier: 08-10-13B
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Conditions

Perforated Appendicitis

Keywords

appendectomy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Postoperative Abscess

  Number of Postoperative Abscess, thirty-day postoperative

  Thirty days after appendectomy

• Number of Participants With Wound Infections

  Number of Wound Infections, 30-days postoperative

  Thirty days following appendectomy

• Number Participants With Readmission Within 30 Days

  Number of Readmission within 30 days postoperative

  Thirty days following appendectomy

• Hospital Charge

  Cost of Hospital services

  Thirty days following appendectomy

Study Arms (2)

home intravenous ertapenem and PICC

ACTIVE COMPARATOR

Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily)

Drug: home intravenous ertapenem; Device: peripheral inserted central Catheter

home oral amoxicillin-clavulanate

EXPERIMENTAL

Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).

Drug: home oral amoxicillin-clavulanate

Interventions

home intravenous ertapenem DRUG

see arm description

Also known as: Invanz

home intravenous ertapenem and PICC

home oral amoxicillin-clavulanate DRUG

see arm description

Also known as: Augmentin

home oral amoxicillin-clavulanate

peripheral inserted central Catheter DEVICE

All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.

Also known as: PICC

home intravenous ertapenem and PICC

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

You may not qualify if:

• Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Appendicitis

Interventions

Ertapenem; Amoxicillin-Potassium Clavulanate Combination; Catheterization, Peripheral

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Dr. B. Todd Heniford
• Organization: Atrium Health

Todd.Heniford@atriumhealth.org

704-355-3168

Study Officials

• Brant T Heniford, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 31, 2016
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 17, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-02