AppendicitisPhase 4METRONCT02561117
Once Daily Metronidazole for Perforated Appendicitis
A Phase 4 study testing Metronidazole in people with Appendicitis, run by Ahmed Nasr.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
About this study
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
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
- Being tested
- Metronidazole
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
Administration once daily
| Study group | Role | What they receive |
|---|---|---|
| q8h | Active comparator | Metronidazole given every 8 hours Receives: Drug: Metronidazole |
| q24h | Experimental | Metronidazole given once daily Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: until discharge (usually less than one week after admission)
Secondary outcomes (6)
Failure of antibiotics
- 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.
Measured: during hospital stay (usually less than one week)
Quantity of narcotics
mg/kg per day of narcotics
Measured: 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
total number of days of narcotics
Measured: 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
duration of IV antibiotic therapy (days)
Measured: 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
duration of oral antibiotic therapy following discharge (days)
Measured: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
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.)
Measured: From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Nasr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Nasr, Children's Hospital of Eastern Ontario
- Investigators
- Ahmed Nasr, Principal investigator, CHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561117
- Sponsor's protocol ID
- 4660
- Acronym
- METRO
- Status last verified
- Jul 2017
- First submitted
- 23 Sep 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02561117
- Acronym / sponsor ID
- METRO / 4660
- Conditions
- Appendicitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ahmed NasrUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| q8h | Active comparator | Drug: MetronidazoleMetronidazole given every 8 hours |
| q24h | Experimental | Drug: MetronidazoleMetronidazole given once daily |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleAlso: FlagylAdministration once daily | Drug | q24h, q8h |
Primary outcome
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)
6 secondary outcomes
Failure of antibiotics
Time frame: during hospital stay (usually less than one week)
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.
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.
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 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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Nasr principal investigator
CHEO
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole in people with Appendicitis, run by Ahmed Nasr.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: until discharge (usually less than one week after admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 2 Nov 2026.