AppendicitisPhase 4NCT02991937
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
A Phase 4 study testing Piperacillin/Tazobactam and Surgical Treatment in people with Appendicitis, run by NYU Langone Health at 1 site in United States.
Trial summary
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Piperacillin/Tazobactam and Surgical Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 1 Dec 2020
- Phase
- Phase 4
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- first episode of appendicitis
- Pain < 48 hours
- White blood cell count < 18,000
- temperature < 103º F
- radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
- appendiceal diameter < 11 mm
- ability to take oral antibiotics
Who cannot join
- Prior antibiotic treatment for appendicitis
- presence of medical condition prohibiting surgical therapy
- radiographic or clinical evidence of abscess or perforation
- appendiceal mass, positive pregnancy test
- other diagnosis equally as likely as appendicitis
- pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
- inability to take oral antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.
- Conditions
- Appendicitis
- Being tested
- Piperacillin/Tazobactam, Surgical Treatment
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/TazobactamDrug
24 hours of IV antibiotic administration
Surgical TreatmentProcedure or surgery
Also called Appendectomy
Appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Medical Therapy | Active comparator | Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics. Receives: Drug: Piperacillin/Tazobactam |
| Surgical Intervention | Active comparator | Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care. Receives: Drug: Piperacillin/Tazobactam; Procedure: Surgical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL.
Measured: 1 Year
Secondary outcomes (2)
Readmission Rates
Percentage of patients readmitted to the hospital after discharge.
Measured: 1 Year
Incidence of Long-term Complications in Medical Therapy Group
Incidence of long-term complications will be reported as number of cases where appendicitis reoccurred resulting in appendectomies in participants of the medical therapy arm. This data will be obtained from medical record review.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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 AppendicitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Fisher, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991937
- Sponsor's protocol ID
- 16-00655
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2016
- Last updated
- 21 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No