Perforated AppendicitisPhase 4NCT03289351
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
A Phase 4 study testing Piperacillin, Tazobactam Drug Combination in people with Perforated Appendicitis and Postoperative Infection, run by Phoenix Children's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforated Appendicitis, Postoperative Infection
- What is being tested?
- Piperacillin, Tazobactam Drug Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2017to 7 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Postoperative Perforated Appendicitis (documented by intraoperative photo)
- Postoperative Laparoscopic Appendectomy
Who cannot join
- Nonperforated Gangrenous Appendicitis
- Nonperforated Purulent Appendicitis
- Open Appendectomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Hospital
Kansas City, Missouri, 64108
Phoenix Children's Hospital
Phoenix, Arizona, 85016
About this study
Official title: Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
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.
Read the 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.
- Conditions
- Perforated Appendicitis, Postoperative Infection
- Being tested
- Piperacillin, Tazobactam Drug Combination
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin, Tazobactam Drug CombinationDrug
Also called piperacillin-tazobactam, Zosyn
Single drug therapy
| Study group | Role | What they receive |
|---|---|---|
| 2-drug Therapy | No intervention | ceftriaxone/metronidazole |
| 1-drug Therapy | Experimental | piperacillin-tazobactam Receives: Drug: Piperacillin, Tazobactam Drug Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Postoperative Intra-abdominal Abscess
Intra-abdominal abscess documented by ultrasound or computerized tomography
Measured: 30 days
Secondary outcomes (2)
Number of Participants With Postoperative Surgical Site Infection
surgical site infections including superficial port site infection
Measured: 30 days
Number of Participants With a Postoperative Readmission
readmission within 30 days for any gastrointestinal complaints or infectious complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start22 May 2017
- Primary completion17 Nov 2021
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Lee, MD, Principal investigator, Phoenix Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289351
- Sponsor's protocol ID
- 17-011
- Status last verified
- Mar 2023
- First submitted
- 18 Sep 2017
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT03289351
- Acronym / sponsor ID
- 17-011
- Conditions
- Perforated Appendicitis, Postoperative Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-drug Therapy | No intervention | –ceftriaxone/metronidazole |
| 1-drug Therapy | Experimental | Drug: Piperacillin, Tazobactam Drug Combinationpiperacillin-tazobactam |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Postoperative Perforated Appendicitis (documented by intraoperative photo)
- Postoperative Laparoscopic Appendectomy
Key exclusion criteria (3 listed)
- Nonperforated Gangrenous Appendicitis
- Nonperforated Purulent Appendicitis
- Open Appendectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin, Tazobactam Drug CombinationAlso: piperacillin-tazobactam, ZosynSingle drug therapy | Drug | 1-drug Therapy |
Primary outcome
Number of Participants With a Postoperative Intra-abdominal Abscess
Time frame: 30 days
Intra-abdominal abscess documented by ultrasound or computerized tomography
2 secondary outcomes
Number of Participants With Postoperative Surgical Site Infection
Time frame: 30 days
Number of Participants With a Postoperative Readmission
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Perforated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Lee, MD principal investigator
Phoenix Childrens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piperacillin, Tazobactam Drug Combination in people with Perforated Appendicitis and Postoperative Infection, run by Phoenix Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Postoperative Intra-abdominal Abscess (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.