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Once Daily Metronidazole for Perforated Appendicitis (METRO)

Primary Purpose

Appendicitis

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Metronidazole

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All children 5-18 years of age, presenting to CHEO with perforated appendicitis (confirmed either in the operating room or diagnosed preoperatively according to radiological criteria), and managed surgically will be assessed for eligibility to participate. These patients may participate if baseline lab values of serum AST (SGOT), AL T (SGPT), LDH, triglycerides and hexokinase glucose are normal, complete physical exam is normal, hGC test is negative for pregnancy (if the patient is a female of reproductive age) and none of the exclusion criteria are present.

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

q8h

q24h

Arm Description

Metronidazole given every 8 hours

Metronidazole given once daily

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Failure of antibiotics

o No clinical improvement after five days, as decided by the patient's surgeon. This will result in the patient being switched to a regimen of different antibiotics.

Quantity of narcotics

mg/kg per day of narcotics

Duration of narcotics

total number of days of narcotics

Duration of antibiotics IV

duration of IV antibiotic therapy (days)

Duration of antibiotics oral

duration of oral antibiotic therapy following discharge (days)

Theoretical cost in CAD

In our study, due to blinding, much of the potential cost-savings of once-daily administration of metronidazole - including nursing time, pharmacy time, and IV materials - will not be evident. However, we will calculate the potential cost-savings of once-daily administration. This will be based on number of hours of nursing time saved (the research coordinator (RC) will, on 10 occasions, observe a nurse administering a dose of metronidazole to a patient not enrolled in this study, and will average these to estimate the time required to administer one dose), number of hours of pharmacy time saved (the RC will, on 10 occasions, observe a pharmacist preparing a dose of metronidazole for a patient not enrolled in this study, and will average these to estimate the time required to prepare one dose), and cost saved on materials (the minibag used to deliver the antibiotic, the IV needle and line if it needed to be replaced, etc.)

Full Information

NCT ID

NCT02561117

First Posted

September 23, 2015

Last Updated

July 18, 2017

Sponsor

Ahmed Nasr

1. Study Identification

Unique Protocol Identification Number

NCT02561117

Brief Title

Once Daily Metronidazole for Perforated Appendicitis

Acronym

METRO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ahmed Nasr

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

q8h

Arm Type

Active Comparator

Arm Description

Metronidazole given every 8 hours

Arm Title

q24h

Arm Type

Experimental

Arm Description

Metronidazole given once daily

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Other Intervention Name(s)

Flagyl

Intervention Description

Administration once daily

Primary Outcome Measure Information:

Title

Length of stay

Description

• 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)

Time Frame

until discharge (usually less than one week after admission)

Secondary Outcome Measure Information:

Title

Failure of antibiotics

Description

o No clinical improvement after five days, as decided by the patient's surgeon. This will result in the patient being switched to a regimen of different antibiotics.

Time Frame

during hospital stay (usually less than one week)

Title

Quantity of narcotics

Description

mg/kg per day of narcotics

Time Frame