Once Daily Metronidazole for Perforated Appendicitis

NCT02561117 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 4660
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Length of stay

  • Duration of hospital stay (in days) during initial admission for perforated appendicitis (Patient will be discharged when eating normal diet, afebrile for 24 hours and no abdominal pain)

  until discharge (usually less than one week after admission)

Secondary Outcomes (6)

• Failure of antibiotics

  during hospital stay (usually less than one week)

• Quantity of narcotics

  From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.

• Duration of narcotics

  From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.

• Duration of antibiotics IV

  From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.

• Duration of antibiotics oral

  From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.

Study Arms (2)

q8h

ACTIVE COMPARATOR

Metronidazole given every 8 hours

Drug: Metronidazole

q24h

EXPERIMENTAL

Metronidazole given once daily

Drug: Metronidazole

Interventions

Metronidazole DRUG

Administration once daily

Also known as: Flagyl

q24h; q8h

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ahmed Nasr: lead

MeSH Terms

Conditions

Appendicitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed Nasr

  CHEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 21, 2017

Record last verified: 2017-07