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Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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: NCT03289351
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Perforated Appendicitis Postoperative Infection Drug: piperacillin-tazobactam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 22, 2020
Estimated Study Completion Date : December 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 2-drug Therapy
ceftriaxone/metronidazole
Experimental: 1-drug Therapy
piperacillin-tazobactam
Drug: piperacillin-tazobactam
Single drug therapy




Primary Outcome Measures :
  1. Postoperative Intra-abdominal Abscess [ Time Frame: 30 days ]
    Intra-abdominal abscess documented by ultrasound or computerized tomography


Secondary Outcome Measures :
  1. Postoperative Surgical Site Infection [ Time Frame: 30 days ]
    surgical site infections including superficial port site infection

  2. Postoperative Readmission [ Time Frame: 30 days ]
    readmission within 30 days for any gastrointestinal complaints or infectious complications

  3. Postoperative Antibiotic Charge [ Time Frame: 30 days ]
    any additional antibiotics prescribed due to infectious complications

  4. Interventions for postoperative abscess [ Time Frame: 30 days ]
    drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289351


Contacts
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Contact: Justin Lee, MD (602) 933-7007 jlee8@phoenixchildrens.com

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Justin Lee, MD    602-933-7007    jlee8@phoenixchildrens.com   
United States, Missouri
Children's Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
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Principal Investigator: Justin Lee, MD Phoenix Childrens Hospital
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Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT03289351    
Other Study ID Numbers: 17-011
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action