NCT02561117

Once Daily Metronidazole for Perforated Appendicitis

Metronidazole Every 24 Hours as Part of Triple Antibiotic Therapy for Ruptured Appendicitis in Children Managed Operatively (METRO): a Noninferiority Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ahmed Nasr · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether administering once-daily doses of metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated appendicitis, is as effective in children as delivering it in the standard method of once every eight hours. Reducing the frequency of administration has the potential of decreasing personnel time and healthcare cost and increasing the lifespan of the IV line. To determine the effectiveness once-daily administration, a randomized controlled trial (RCT) will be conducted to compare outcomes between the two treatment schedules. We will recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such as duration of hospital stay and theoretical cost will be measured and analyzed using statistical tests.

Conditions

• Appendicitis

Interventions

Type	Name	Description
DRUG	Metronidazole	Administration once daily

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2015-09-25
• Last updated: 2017-07-21

Regulatory

• FDA-regulated drug study