Clinical Trial: Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis

Brief Summary: The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.

Detailed Summary:

Triple antibiotic therapy providing broad spectrum coverage of gram positive, gram negative and anaerobic bacteria has long been the standard treatment for perforated appendicitis in children. This regimen has traditionally consisted of ampicillin, gentamicin, and clindamycin. The dosing regimen for these medications are quite frequent, as follows: ampicillin (every 6 hours), gentamicin (every 8 hours), and clindamycin (every 8 hours), until there is no evidence for postoperative infection, usually 5 to 7 days. Further, gentamicin is an aminoglycoside with known renal and ototoxic side effects. Its therapeutic window is small necessitating measurement of serum levels to maintain therapeutic levels and avoid toxicity. The contemporary selection of antibiotics includes very few drugs that require such monitoring.

Monotherapy with newer broad-spectrum agents such as piperacillin/tazobactam for intraabdominal infections has recently been demonstrated to be equally efficacious as traditional triple therapy. Such data calls into question the need for such onerous antibiotic regimens which include a nephrotoxic agent (gentamycin). However, the benefits of monotherapy are outweighed by the increased expense of the antibiotic, and the ongoing cumbersome dosing schedule of 3-4 doses daily. We have recently moved to a dual antibiotic regimen (ceftriaxone and metronidazole) which provides excellent antimicrobial coverage and can be dosed on a once daily dosing schedule with an identical duration of therapy as for the triple antibiotic regimen. This regimen has proven effective in adults with intraabdominal infections such as perforated appendicitis. Further, ceftriaxone plus metronidazole has been shown equal to the aforementioned monotherapy schedule with piperacillin/tazobactam in children with complicated perforated appendicitis. The advantages of dual antibiotic therapy with once
Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome:

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Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: September 12, 2005
Date Started: April 2005
Date Completion:
Last Updated: April 5, 2007
Last Verified: September 2005