Clostridium Difficile DiarrheaPhase 4NCT02200328
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
A Phase 4 study testing Metronidazole in people with Clostridium Difficile Diarrhea, run by Alison Schneider at 1 site in United States.
Trial summary
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Clostridium Difficile Diarrhea
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients >55
- Proton Pump inhibitor / Histamine-2 Blocker
- On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
- Anticipated hospital stay >48 hours
- Mental capacity (able to give informed written consent).
Who cannot join
- Admission for CDI
- Existing diarrhea at admission
- Passed prophylactic window (>48 hours on broad spectrum antibiotics)
- Unable to take PO at the time of evaluation for study entry
- No more than 14 days of broad spectrum antibiotics anticipated
- Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
Show all 15Show fewer
- Inflammatory Bowel Disease
- Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
- Hospice
- Mortality expected <7days
- Previous CDI in the past 6 months
- Intensive care admission due to the difficulty of monitoring them
- Allergy to Metronidazole or other Antibiotics in protocol
- Patients with neuropathy
- History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
Read the detailed description
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. This infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. This infection also increases medical costs by prolonging hospital stays.
Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. Flagyl is approved by the Food and Drug Administration for the treatment of C. diff infection. Recent research by the investigators group has shown that hospitalized patients who took Flagyl had a decreased chance of getting C. Diff infection. However, high quality studies are needed to better evaluate whether the investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.
The purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients at high risk for this infection.
High risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-Zosyn; Ciprofloxacin).
- Conditions
- Clostridium Difficile Diarrhea
- Being tested
- Metronidazole, Placebo
- Keywords
- Clostridium difficile infection, Diarrhea, Flagyl, Metronidazole
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
PlaceboDrug
Also called corn starch pill
Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
Measured: 30 days
Secondary outcomes (1)
Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Patients noncompliant with instructions and follow ups could not be completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile DiarrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Schneider
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alison Schneider, Cleveland Clinic Florida
- Investigators
- Alison Schneider, M.D., Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200328
- Sponsor's protocol ID
- FLA14-061
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2014
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02200328
- Acronym / sponsor ID
- FLA14-061
- Conditions
- Clostridium Difficile Diarrhea
- Keywords
- Clostridium difficile infection, Diarrhea, Flagyl, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients noncompliant with instructions and follow ups could not be completed.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Alison SchneiderUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Posted 10 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
Detailed description
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. This infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. This infection also increases medical costs by prolonging hospital stays.
Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. Flagyl is approved by the Food and Drug Administration for the treatment of C. diff infection. Recent research by the investigators group has shown that hospitalized patients who took Flagyl had a decreased chance of getting C. Diff infection. However, high quality studies are needed to better evaluate whether the investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.
The purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients at high risk for this infection.
High risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-Zosyn; Ciprofloxacin).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: MetronidazoleMetronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo(Corn starch pill) orally 3 times a day for a maximum of 14 days |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients >55
- Proton Pump inhibitor / Histamine-2 Blocker
- On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
- Anticipated hospital stay >48 hours
- Mental capacity (able to give informed written consent).
Key exclusion criteria (15 listed)
- Admission for CDI
- Existing diarrhea at admission
- Passed prophylactic window (>48 hours on broad spectrum antibiotics)
- Unable to take PO at the time of evaluation for study entry
- No more than 14 days of broad spectrum antibiotics anticipated
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: FlagylMetronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days | Drug | Metronidazole |
| PlaceboAlso: corn starch pillPlacebo(Corn starch pill) orally 3 times a day for a maximum of 14 days | Drug | Placebo |
Primary outcome
The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
Time frame: 30 days
1 secondary outcome
Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alison Schneider, M.D. principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole in people with Clostridium Difficile Diarrhea, run by Alison Schneider at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use. (time frame: 30 days). 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 17 May 2017.