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Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Primary Purpose

Perforated Appendicitis, Postoperative Infection

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Piperacillin, Tazobactam Drug Combination
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Appendicitis

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Postoperative Perforated Appendicitis (documented by intraoperative photo)
  • Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy

Sites / Locations

  • Phoenix Children's Hospital
  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2-drug Therapy

1-drug Therapy

Arm Description

ceftriaxone/metronidazole

piperacillin-tazobactam

Outcomes

Primary Outcome Measures

Postoperative Intra-abdominal Abscess
Intra-abdominal abscess documented by ultrasound or computerized tomography

Secondary Outcome Measures

Postoperative Surgical Site Infection
surgical site infections including superficial port site infection
Postoperative Readmission
readmission within 30 days for any gastrointestinal complaints or infectious complications
Postoperative Antibiotic Charge
any additional antibiotics prescribed due to infectious complications
Interventions for postoperative abscess
drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics

Full Information

First Posted
September 18, 2017
Last Updated
March 28, 2023
Sponsor
Phoenix Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03289351
Brief Title
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Official Title
Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
September 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phoenix Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.
Detailed Description
The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Appendicitis, Postoperative Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-drug Therapy
Arm Type
No Intervention
Arm Description
ceftriaxone/metronidazole
Arm Title
1-drug Therapy
Arm Type
Experimental
Arm Description
piperacillin-tazobactam
Intervention Type
Drug
Intervention Name(s)
Piperacillin, Tazobactam Drug Combination
Other Intervention Name(s)
piperacillin-tazobactam, Zosyn
Intervention Description
Single drug therapy
Primary Outcome Measure Information:
Title
Postoperative Intra-abdominal Abscess
Description
Intra-abdominal abscess documented by ultrasound or computerized tomography
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Postoperative Surgical Site Infection
Description
surgical site infections including superficial port site infection
Time Frame
30 days
Title
Postoperative Readmission
Description
readmission within 30 days for any gastrointestinal complaints or infectious complications
Time Frame
30 days
Title
Postoperative Antibiotic Charge
Description
any additional antibiotics prescribed due to infectious complications
Time Frame
30 days
Title
Interventions for postoperative abscess
Description
drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics
Time Frame
30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postoperative Perforated Appendicitis (documented by intraoperative photo) Postoperative Laparoscopic Appendectomy Exclusion Criteria: Nonperforated Gangrenous Appendicitis Nonperforated Purulent Appendicitis Open Appendectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Lee, MD
Organizational Affiliation
Phoenix Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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