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Once Daily Metronidazole for Perforated Appendicitis (METRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02561117
Recruitment Status : Withdrawn (Lack of funding)
First Posted : September 25, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Nasr, Children's Hospital of Eastern Ontario

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.


Condition or disease Intervention/treatment Phase
Appendicitis Drug: Metronidazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: q8h
Metronidazole given every 8 hours
Drug: Metronidazole
Administration once daily
Other Name: Flagyl

Experimental: q24h
Metronidazole given once daily
Drug: Metronidazole
Administration once daily
Other Name: Flagyl




Primary Outcome Measures :
  1. Length of stay [ Time Frame: until discharge (usually less than one week after admission) ]
    • 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 :
  1. Failure of antibiotics [ Time Frame: during hospital stay (usually less than one week) ]
    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.

  2. Quantity of narcotics [ Time Frame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. ]
    mg/kg per day of narcotics

  3. Duration of narcotics [ Time Frame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. ]
    total number of days of narcotics

  4. Duration of antibiotics IV [ Time Frame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. ]
    duration of IV antibiotic therapy (days)

  5. Duration of antibiotics oral [ Time Frame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. ]
    duration of oral antibiotic therapy following discharge (days)

  6. Theoretical cost in CAD [ Time Frame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. ]
    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.)



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561117


Sponsors and Collaborators
Ahmed Nasr
Investigators
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Principal Investigator: Ahmed Nasr CHEO
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Responsible Party: Ahmed Nasr, Principal Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02561117    
Other Study ID Numbers: 4660
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents