Once Daily Metronidazole for Perforated Appendicitis

NCT ID: NCT02561117

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2022-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

q8h

Metronidazole given every 8 hours

Group Type: ACTIVE_COMPARATOR

Metronidazole

Intervention Type: DRUG

Administration once daily

q24h

Metronidazole given once daily

Group Type: EXPERIMENTAL

Metronidazole

Intervention Type: DRUG

Administration once daily

Interventions

Metronidazole

Administration once daily

Intervention Type: DRUG

Other Intervention Names

Flagyl

Eligibility Criteria

Exclusion Criteria

• Any known co-existing gastrointestinal disease
• Uncertainty about the diagnosis
• Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
• A known allergy to any of the antibiotics to be used in this trial
• An active neurological disorder
• Receiving medical treatment for a neurological disorder
• A history of blood dyscrasia, hypothyroidism or hypoadrenalism
• Hepatic disease
• Renal impairment
• Patients receiving any other oral or intravenous concomitant antimicrobial at enrollment
• Pregnancy
• Under five years of age
• Patients who have received metronidazole orally or intravenously in the last 14 days, prior to the current admission for appendicitis
• Patients already taking any of the following medications at admission (as these may interact with Metronidazole as stated in the product monograph): disulfiram, oral anticoagulant therapy (warfarin type), phenytoin or phenobarbital, vecuronium, lithium, busulfan
• The physician elects to treat the patient conservatively (non-surgically)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Nasr

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Nasr

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmed Nasr

Role: PRINCIPAL_INVESTIGATOR

CHEO

Other Identifiers

4660

Identifier Type: -

Identifier Source: org_study_id