Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

NCT00462020 | Completed Results

• 1 other identifier: 07 02 031
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Perforated Appendicitis

Keywords

appendicitis, perforation, abscess, treatment

Outcome Measures

Primary Outcomes (1)

• Abscess After Appendectomy

  1 month

Secondary Outcomes (4)

• Operative Time

  1 month

• Time to Regular Diet

  1 month

• Length of Stay After Operation

  1 month

• Total Healthcare Visits

  1 month

Study Arms (2)

1

ACTIVE COMPARATOR

5 days of IV antibiotics after appendectomy

Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole)

2

EXPERIMENTAL

home on oral antibiotics to complete 7 days of treatment when tolerating PO's

Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)

Interventions

5 days of IV antibiotics (ceftriaxone and metronidazole) DRUG

5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)

1

Home with oral antibiotics when eating (ampicillin/clavulanic acid) DRUG

Augmentin 40mg/kg BID when tolerating POs to complete 7 days total

2

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy

You may not qualify if:

• Known immune deficiency
• Abscess identified on pre-op imaging
• Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Appendicitis; Abscess

Interventions

Anti-Bacterial Agents; Ceftriaxone; Metronidazole; Home Care Services; Ampicillin; Clavulanic Acid

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services; Penicillin G; Penicillins; Clavulanic Acids

Results Point of Contact

• Title: Shawn D. St. Peter, MD
• Organization: Children's Mercy Hospital

sspeter@cmh.edu

816-983-6479

Study Officials

• Shawn D St. Peter

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 16, 2007
• First Posted: April 18, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 21, 2021
• Results First Posted: December 13, 2011

Record last verified: 2021-02

Locations

US (1)