An interventional study of Antibiotics only (Zosyn then Augmentin) in Appendicitis, sponsored by Peter Minneci. Terminated at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by Peter Minneci · Not applicable, Interventional, and Treatment
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 14 is below the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Peter Minneci is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
US or CT confirmed early appendicitis plus:
Exclusion Criteria:
Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
Drug: Antibiotics only (Zosyn then Augmentin)
Usual care with urgent appendectomy
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
Also known as: non operative management
Number of Participants That Did Not Have an Appendectomy
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
Time frame: 1 year
Number of Participants With Complicated Appendicitis
Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
Time frame: 1 year
| Milestone | Non-operative | Surgery |
|---|---|---|
| Started | 5 | 9 |
| Completed | 5 | 9 |
| Not completed | 0 | 0 |
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
| Participants | Non-operative | Surgery |
|---|---|---|
| Number of Participants That Did Not Have an Appendectomy | 2 | 0 |
Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
| Participants | Non-operative | Surgery |
|---|---|---|
| Number of Participants With Complicated Appendicitis | 0 | 6 |
Collected over Adverse events data were collected for the duration of the follow-ups which was up to 1 year post-discharge.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-operative | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Surgery | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Non-operative | Surgery | Total |
|---|---|---|---|
| Median | 14 (13 to 14) | 11 (9 to 15) | 12 (11 to 14) |
| Sex: Female, Male(Participants) | Non-operative | Surgery | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 1 | 5 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Non-operative | Surgery | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 5 | 7 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Non-operative | Surgery | 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 | 3 | 1 | 4 |
| White | 2 | 8 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: No
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Peter Minneci