A Phase 4 interventional study of Piperacillin, Tazobactam Drug Combination in Perforated Appendicitis and Postoperative Infection, sponsored by Phoenix Children's Hospital. Completed at 2 sites in United States. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Phoenix Children's Hospital · Phase 4, Interventional, and Treatment
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's enrollment of 162 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
ceftriaxone/metronidazole
piperacillin-tazobactam
Drug: Piperacillin, Tazobactam Drug Combination
Single drug therapy
Also known as: piperacillin-tazobactam, Zosyn
Number of Participants With a Postoperative Intra-abdominal Abscess
Intra-abdominal abscess documented by ultrasound or computerized tomography
Time frame: 30 days
Number of Participants With Postoperative Surgical Site Infection
surgical site infections including superficial port site infection
Time frame: 30 days
Number of Participants With a Postoperative Readmission
readmission within 30 days for any gastrointestinal complaints or infectious complications
Time frame: 30 days
| Milestone | 2-drug Therapy | 1-drug Therapy |
|---|---|---|
| Started | 80 | 82 |
| Completed | 80 | 82 |
| Not completed | 0 | 0 |
Intra-abdominal abscess documented by ultrasound or computerized tomography
| Participants | 2-drug Therapy | 1-drug Therapy |
|---|---|---|
| Number of Participants With a Postoperative Intra-abdominal Abscess | 19 | 5 |
surgical site infections including superficial port site infection
| Participants | 2-drug Therapy | 1-drug Therapy |
|---|---|---|
| Number of Participants With Postoperative Surgical Site Infection | 4 | 4 |
readmission within 30 days for any gastrointestinal complaints or infectious complications
| Participants | 2-drug Therapy | 1-drug Therapy |
|---|---|---|
| Number of Participants With a Postoperative Readmission | 11 | 4 |
Collected over Assessed up to 30 days postoperatively.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2-drug Therapy | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) |
| 1-drug Therapy | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Event | 2-drug Therapy | 1-drug Therapy |
|---|---|---|
| Perioperative Redness/EdemaSkin and subcutaneous tissue disorders | 1/80 | 0/82 |
| Age, Categorical(Participants) | 2-drug Therapy | 1-drug Therapy | Total |
|---|---|---|---|
| <=18 years | 80 | 82 | 162 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 2-drug Therapy | 1-drug Therapy | Total |
|---|---|---|---|
| Female | 30 | 36 | 66 |
| Male | 50 | 46 | 96 |
| Ethnicity (NIH/OMB)(Participants) | 2-drug Therapy | 1-drug Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 80 | 82 | 162 |
| Race (NIH/OMB)(Participants) | 2-drug Therapy | 1-drug Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 80 | 82 | 162 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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