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Trial record 100 of 530 for:    VANCOMYCIN

Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections

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: NCT02774382
Recruitment Status : Unknown
Verified September 2017 by Andreas Munk Petersen, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : May 17, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Andreas Munk Petersen, Hvidovre University Hospital

Brief Summary:
The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: Vancomycin Drug: Fecal microbiota transplantation Drug: Rectal bacteriotherapy Phase 3

Detailed Description:

Clostridium difficile infection (CDI) is the most common nosocomial infection in the western world. CDI is associated with high morbidity and mortality and is a great burden for the health care system leading Center of Disease Control and Prevention (CDC) to identify it as one of three most important/urgent threats to public health.

Despite antimicrobial treatment of CDI, 20% of the patients have recurrence of CDI. Due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective.

Fecal microbiota transplantation (FMT) is an alternative treatment for recurrent CDI. Studies have shown a cure rate up to 90% in patients with recurrent CDI. One alternative to FMT is rectal bacteriotherapy (RBT) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. RBT has never been investigated in a clinical trial.

The project is a randomized controlled trial including 450 patients with recurrent CDI will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either FMT or RBT. The patients will be followed up for 180 days. Cure is defined as resolution of CDI symptoms 90 days after treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Vancomycin

Oral vancomycin according to number of recurrences (Danish guidelines):

First recurrence: Capsule vancomycin 125 mg x 4 p.o. times daily for 14 days

≥2 recurrences:

  • capsule vancomycin 125 mg x 4 times daily p.o. for 14 days followed by
  • capsule vancomycin 125 mg x 2 times daily p.o. for 7 days followed by
  • capsule vancomycin 125 mg x 1 times daily p.o. for 7 days followed by
  • capsule vancomycin 125 mg x 1 p.o. every second day for 7 days followed by
  • capsule vancomycin 125 mg x 1 p.o. every third day for 14 days
Drug: Vancomycin
Already incl. in arm description

Experimental: Vancomycin + fecal microbiota transplantation
Capsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Fecal Microbiota Transplantation with 200 ml fecal suspension administrated with a rectal catheter.
Drug: Vancomycin
Already incl. in arm description

Drug: Fecal microbiota transplantation
Already incl. in arm description

Experimental: Vancomycin + rectal bacteriotherapy
Capsule vancomycin 125 mg x 4 times daily p.o. for 7-14 days followed by Rectal bacteriotherapy with 200 ml suspension of a fixed mixture of bacterial strains administrated with a rectal catheter.
Drug: Vancomycin
Already incl. in arm description

Drug: Rectal bacteriotherapy
Already incl. in arm description




Primary Outcome Measures :
  1. Clinical cure of recurrent Clostridium difficile infection defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. [ Time Frame: 90 days ]
    Clinical cure defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out af digital questionnaire.


Secondary Outcome Measures :
  1. Early or late recurrence of CDI after the end of treatment defined as recurrence of symptoms of CDI and a positive stool sample with Clostridium difficile (PCR). [ Time Frame: 30 and 180 days after ended treatment ]
    Patient with recurrence of CDI in the follow up period will be categorized as an early recurrence if the recurrence is in the first 30 days after treatment and as a late recurrence if the recurrence is after 180 days after treatment. The investigator will call the patient by telephone and fill out af digital questionnaire and thereafter categorize the patient.

  2. Days with diarrhea [ Time Frame: 1, 4, 8 and 12 days after ended treatment ]
  3. CDI-associated hospital admission and hospital admission of other causes in the follow-up period [ Time Frame: 180 days after ended treatment ]
  4. CDI-associated hospital outpatient contact and hospital outpatient contact of other causes in the follow-up period [ Time Frame: 180 days after ended treatment ]
  5. CDI-associated mortality and all-cause mortality [ Time Frame: 30, 90 and 180 days after ended treatment ]
  6. Compare numbers of patients with clinical cure after study treatment divided into two groups depending on numbers of recurrences of CDI. [ Time Frame: 90 days after ended treatment ]

    Clinical cure is defined as patient-reported abscence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out a digital questionnaire. Number of patients with clinical cure of recurrent Clostridium difficile infection will be divided into two groups according to numbers of recurrences of CDI;

    • Group 1; patients with one recurrence
    • Group 2; patients with 2 or more recurrences. The division will be done based on patient records and the questionnaire. The information will be aggregated in the digital journal unique to this trial. The numbers of patients with clinical cure in the two groups will be compared to see if one group response better to study treatment than the other.

  7. Effect of the treatment depending on the CD strain - i.e. toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases. [ Time Frame: 90 days after ended treatment ]
    The investigator will call the patient by telephone and fill out af digital questionnaire. The lab result will give the investigator information about which strain the patient was infected with and this will be aggregated in the digital patient journal.

  8. Effect of the treatment depending on the patients serum-level of antibodies towards toxin A and B at the time of inclusion. [ Time Frame: 90 days after ended treatment ]
    At inclusion the investigator will collect a blood sample to analysis for toxin A and B antibodies. The lab result will be aggregated in the digital patient journal.

  9. Side effects in the three treatment arms [ Time Frame: 14 days after ended treatment ]
  10. Characterisation of the gut microbiota before and after treatment with FMT/RBT in conjunction with characterisation of the donor's microbiota or the RBT bacterial mix. [ Time Frame: 180 days after ended treatment ]
    Performed in a subgroup of patients.

  11. Other antibiotic treatments associated with new recurrences of CDI [ Time Frame: Within 180 days after ended treatment ]
    The investigator will call the patient by telephone and fill out af digital questionnaire. Furthermore the investigator has access to a database with all prescription drugs incl. antibiotics. These informations will be collected and aggregated in the digital patient journal unique for this study.

  12. Evaluation of the composition of bile acids before and after treatment with FMT/RBT. [ Time Frame: 90 days after ended treatment ]
    Analyzed in conjunction with the microbiota composition and the treatment effect. Performed in a subgroup of patients.

  13. Characterisation of the CD strains by whole genome sequencing [ Time Frame: 90 days after ended treatment ]
    Characterisation of the CD strains involved to determine if a potential recurrence is a true recurrence or a reinfection with another strain. Whole genome sequencing will be performed by the department of Clinical Microbiology in Hvidovre Hospital. This information will be collected by the investigator and aggregated in the digital patient journal unique for this trial.

  14. Identification of age as a risk factor for treatment success/failure [ Time Frame: 90 days after ended treatment ]
    The investigator will call the patient by telephone for information about abscence of CDI and fill out af digital questionnaire. This information and the patient's age will be aggregated in the digital patient journal.

  15. Identifying if Charlson comorbidity index is associated to treatment success/failure. [ Time Frame: 90 days after ended treatment ]
    At inclusion the patient's Charlson Comorbidity index will be calculated and put in the patient's record unique to this trial.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Verified recurrent CDI with symptoms of CDI and microbiological verification (PCR).
  • Previously treated for CDI with at least 10 days of vancomycin or metronidazole.
  • Be able to read and understand Danish.

Exclusion Criteria:

  • Life expectancy < 3 months.
  • Allergy toward vancomycin
  • Other infection in the GI tract with clinical symptoms similar to CDI.
  • Other illness in the GI tract with clinical symptoms similar to CDI.
  • Use of antibiotics for more than 14 days treating other infections
  • Planning pregnancy, pregnancy or breast feeding.
  • Severe immune suppression which makes FMT/RBT relatively contraindicated

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): NCT02774382


Contacts
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Contact: Andreas M Petersen, MD, PhD +4538625960 andreasmunkpetersen@regionh.dk

Locations
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Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Mahtab Chehri, MD    +4538626785    mahtab.chehri.02@regionh.dk   
Contact: Andreas M Petersen, Clinical associate professor         
Principal Investigator: Andreas M Petersen, Clinical associate professor         
Sub-Investigator: Mahtab Chehri, MD         
Køge sygehus Recruiting
Køge, Denmark, 4600
Contact: Anne R Olsen, MD         
Contact: Peter M Bytzer, Professor MD PhD         
Sub-Investigator: Anne R Olsen, MD         
Principal Investigator: Peter M Bytzer, Professor MD         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Andreas M Petersen, MD PhD Hvidovre University Hospital

Additional Information:
Publications:

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Responsible Party: Andreas Munk Petersen, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02774382     History of Changes
Other Study ID Numbers: SJ-478
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:
Recurrence
Infection
Additional relevant MeSH terms:
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Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents