Clinical trial NCT02561117: Once Daily Metronidazole for Perforated Appendicitis
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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Length of stay
timeFrame: until discharge (usually less than one week after admission)
Secondary outcomes:
measure: Failure of antibiotics
timeFrame: during hospital stay (usually less than one week)
measure: Quantity of narcotics
timeFrame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
measure: Duration of narcotics
timeFrame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
measure: Duration of antibiotics IV
timeFrame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
measure: Duration of antibiotics oral
timeFrame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
measure: Theoretical cost in CAD
timeFrame: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
Other outcomes:
Locations:
Study officials:
affiliation: CHEO
name: Ahmed Nasr
role: PRINCIPAL_INVESTIGATOR
References: