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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Sponsor
Rebiotix Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02589847
Collaborator
(none)
272
Enrollment
30
Locations
2
Arms
41
Actual Duration (Months)
9.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Condition or Disease Intervention/Treatment Phase
  • Biological: RBX2660
  • Drug: Standard of Care Antibiotics
 Phase 2

Detailed Description

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. Efficacy of RBX2660, measured by the recurrence-free rate of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660, will be evaluated by comparing the recurrence-free rate observed in the study population to the recurrence-free rate identified from antibiotic-treated historical controls.

Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: RBX2660 Open-label

RBX2660 (microbiota suspension)

Biological: RBX2660
suspension of intestinal microbes
Other: Historical control antibiotics

Retrospective Historical Control with standard of care

Drug: Standard of Care Antibiotics
Standard of Care Antibiotics
Other Names:
  • Antibiotics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks [8 weeks after treatment]

      Participants were evaluated 8 weeks after study treatment to assess efficacy of RBX2660. Efficacy was assessed as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment.

    Secondary Outcome Measures

    1. Quality of Life (SF-36) [Baseline]

      The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

    2. Quality of Life (SF-36) [8-Weeks]

      The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

    3. Number of Participants With Major Complications of rCDI From Baseline Through 24 Months [24 months]

      Major complications of rCDI, defined as death, septic shock, toxic megacolon, colonic perforation, emergency colectomy, or ICU admission) were collected and reported as a safety-related endpoint.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥ 18 years old.

    • Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.

    • Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.

    • A positive stool test for the presence of C. difficile within 60 days prior to enrollment

    Exclusion Criteria:

    • A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.

    • Requires continuous antibiotic therapy for a condition other than CDI.

    • Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment.

    • Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.

    • Previous treatment with RBX2660.

    • Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.

    • Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.

    • History of chronic diarrhea.

    • History of celiac disease.

    • Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.

    • Colostomy.

    • Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.

    • Life expectancy of < 12 months.

    • Compromised immune system

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States 85054
    2 North Little Rock Arkansas United States 72117
    3 Sacramento California United States 95817
    4 Bay Pines Florida United States 33744
    5 Coral Springs Florida United States 33065
    6 Gainesville Florida United States 32610
    7 Miami Florida United States 33101
    8 Idaho Falls Idaho United States 83404
    9 Chicago Illinois United States 60637
    10 Maywood Illinois United States 60153
    11 Indianapolis Indiana United States 46260
    12 Lafayette Indiana United States 47904
    13 Lexington Kentucky United States 40506
    14 Detroit Michigan United States 48202
    15 Rochester Minnesota United States 55905
    16 Saint Paul Minnesota United States 55130
    17 Saint Louis Missouri United States 63110
    18 Omaha Nebraska United States 68198
    19 Bronx New York United States 10468
    20 Flushing New York United States 11355
    21 Rochester New York United States 14618
    22 Syracuse New York United States 52325
    23 Fargo North Dakota United States 58122
    24 Lima Ohio United States 45801
    25 Jackson Tennessee United States 38305
    26 Houston Texas United States 77025
    27 Springfield Virginia United States 22150
    28 Virginia Beach Virginia United States 23454
    29 Vancouver British Columbia Canada V5Z1M9
    30 Hamilton Ontario Canada L8N4A6

    Sponsors and Collaborators

    • Rebiotix Inc.

    Investigators

    • Study Chair: Arnab Ray, MD, Ochsner Health System

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebiotix Inc.
    ClinicalTrials.gov Identifier:
    NCT02589847
    Other Study ID Numbers:
    • 2015-01
    First Posted:
    Oct 28, 2015
    Last Update Posted:
    Mar 26, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rebiotix Inc.
    Clostridium difficile
    C diff
    CDI
    CDAD
    Fecal transplant
    Fecal Microbiota transplant
    diarrhea
    FMT
    microbiota restoration therapy
    microbiota suspension
    fecal bacteriotherapy
    C diff diarrhea
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Clostridium Infections
    Anti-Bacterial Agents
    Antibiotics, Antitubercular

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title RBX2660 Open-label Historical Control Antibiotics
    Arm/Group Description RBX2660 (microbiota suspension) RBX2660: suspension of intestinal microbes Retrospective Historical Control with standard of care Standard of Care Antibiotics: Standard of Care Antibiotics
    Period Title: Overall Study
    STARTED 162 110
    Safety Population 149 0
    Full Analysis Set (FAS) 149 104
    Evaluable 142 75
    COMPLETED 107 39
    NOT COMPLETED 55 71

    Baseline Characteristics

    Arm/Group Title RBX2660 Open-label Historical Control Antibiotics Total
    Arm/Group Description RBX2660 (microbiota suspension) RBX2660: suspension of intestinal microbes Retrospective Historical Control with standard of care Standard of Care Antibiotics: Standard of Care Antibiotics Total of all reporting groups
    Overall Participants 149 104 253
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    62
    41.6%
    40
    38.5%
    102
    40.3%
    >=65 years
    87
    58.4%
    64
    61.5%
    151
    59.7%
    Sex: Female, Male (Count of Participants)
    Female
    95
    63.8%
    71
    68.3%
    166
    65.6%
    Male
    54
    36.2%
    33
    31.7%
    87
    34.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    2.7%
    5
    4.8%
    9
    3.6%
    Not Hispanic or Latino
    142
    95.3%
    44
    42.3%
    186
    73.5%
    Unknown or Not Reported
    3
    2%
    55
    52.9%
    58
    22.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    3
    2%
    0
    0%
    3
    1.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    7
    4.7%
    3
    2.9%
    10
    4%
    White
    136
    91.3%
    40
    38.5%
    176
    69.6%
    More than one race
    0
    0%
    16
    15.4%
    16
    6.3%
    Unknown or Not Reported
    3
    2%
    45
    43.3%
    48
    19%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks
    Description Participants were evaluated 8 weeks after study treatment to assess efficacy of RBX2660. Efficacy was assessed as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment.
    Time Frame 8 weeks after treatment

    Outcome Measure Data

    Analysis Population Description
    Evaluable Population - All participants evaluable for a treatment outcome through 56 days after completion of treatment.
    Arm/Group Title RBX2660 Open-label Historical Control Antibiotics
    Arm/Group Description RBX2660 (microbiota suspension) RBX2660: suspension of intestinal microbes Retrospective Historical Control with standard of care Standard of Care Antibiotics: Standard of Care Antibiotics
    Measure Participants 142 75
    Treatment Success
    112
    75.2%
    23
    22.1%
    Treatment Failure
    30
    20.1%
    52
    50%
    2. Secondary Outcome
    Title Quality of Life (SF-36)
    Description The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Safety Population - The SP includes all participants who were enrolled and received at least dose of RBX2660.
    Arm/Group Title RBX2660 Open-label
    Arm/Group Description RBX2660 (microbiota suspension)
    Measure Participants 149
    Physical Component Summary (PCS)
    40.3
    (9.3)
    Physical Functioning (PF)
    39.8
    (11.8)
    Role Limitations Due to Physical Health (RP)
    38.0
    (11.3)
    Bodily Pain (BP)
    44.5
    (11.5)
    General Health Perceptions (GH)
    44.6
    (10.7)
    Mental Component Summary (MCS)
    45.5
    (12.3)
    Vitality (VT)
    41.9
    (11.5)
    Social Functioning (SF)
    40.1
    (12.2)
    Role Limitations Due to Emotional Problems (RE)
    43.6
    (12.2)
    Mental Health (MH)
    46.3
    (11.7)
    3. Secondary Outcome
    Title Quality of Life (SF-36)
    Description The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.
    Time Frame 8-Weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Population - The SP includes all participants who were enrolled and received at least dose of RBX2660.
    Arm/Group Title RBX2660 Open-label
    Arm/Group Description RBX2660 (microbiota suspension)
    Measure Participants 149
    Physical Component Summary (PCS)
    44.3
    (11.1)
    Physical Functioning (PF)
    42.2
    (12.6)
    Role Limitations Due to Physical Health (RP)
    43.8
    (10.7)
    Bodily Pain (BP)
    48.6
    (11.8)
    General Health Perceptions (GH)
    48.0
    (10.0)
    Mental Component Summary (MCS)
    50.9
    (10.4)
    Vitality (VT)
    49.0
    (10.5)
    Social Functioning (SF)
    47.2
    (11.3)
    Role Limitations Due to Emotional Problems (RE)
    46.9
    (11.8)
    Mental Health (MH)
    51.0
    (10.6)
    4. Secondary Outcome
    Title Number of Participants With Major Complications of rCDI From Baseline Through 24 Months
    Description Major complications of rCDI, defined as death, septic shock, toxic megacolon, colonic perforation, emergency colectomy, or ICU admission) were collected and reported as a safety-related endpoint.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set- Defined as participants who received at least one dose of RBX2660 or was in the Historical Control Arm
    Arm/Group Title RBX2660 Open-label Historical Control Antibiotics
    Arm/Group Description RBX2660 (microbiota suspension) RBX2660: suspension of intestinal microbes Retrospective Historical Control with standard of care Standard of Care Antibiotics: Standard of Care Antibiotics
    Measure Participants 149 104
    At least one complication of rCDI
    3
    2%
    2
    1.9%
    Death
    1
    0.7%
    0
    0%
    Septic Shock
    2
    1.3%
    1
    1%
    Toxic Megacolon
    0
    0%
    0
    0%
    Colonic Perforations
    0
    0%
    0
    0%
    Emergency Colectomy
    0
    0%
    1
    1%
    ICU Admission
    2
    1.3%
    0
    0%

    Adverse Events

    Time Frame Adverse Events were collected from enrollment through 24 months after treatment for participants who received RBX2660. Historical Control subjects were followed for up to 6 months.
    Adverse Event Reporting Description Treatment emergent adverse events are presented, defined as adverse events that occurred after exposure to study drug. For participants that received RBX2660, at each contact point (in office visit or scheduled phone call) they were systematically asked about adverse events, as well as use of a subject diary for one week post the last study enema.
    Arm/Group Title RBX2660 Open-label Historical Control Antibiotics
    Arm/Group Description RBX2660 (microbiota suspension) RBX2660: suspension of intestinal microbes Retrospective Historical Control with standard of care Standard of Care Antibiotics: Standard of Care Antibiotics
    All Cause Mortality
    RBX2660 Open-label Historical Control Antibiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/149 (10.1%) 5/104 (4.8%)
    Serious Adverse Events
    RBX2660 Open-label Historical Control Antibiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 52/149 (34.9%) 30/104 (28.8%)
    Blood and lymphatic system disorders
    Leukocytosis 1/149 (0.7%) 1 0/104 (0%) 0
    Anaemia 1/149 (0.7%) 1 1/104 (1%) 1
    Thrombocytopenia 0/149 (0%) 0 1/104 (1%) 1
    Febrile neutropenia 1/149 (0.7%) 1 0/104 (0%) 0
    Normochromic normocytic anaemia 0/149 (0%) 0 1/104 (1%) 1
    Cardiac disorders
    Cardiac failure congestive 5/149 (3.4%) 5 1/104 (1%) 1
    Acute myocardial infarction 2/149 (1.3%) 2 3/104 (2.9%) 3
    Atrial fibrillation 2/149 (1.3%) 2 0/104 (0%) 0
    Ventricular tachycardia 1/149 (0.7%) 1 0/104 (0%) 0
    Acute coronary syndrome 1/149 (0.7%) 1 1/104 (1%) 1
    Arrhythmia 1/149 (0.7%) 1 1/104 (1%) 1
    Cardiac arrest 2/149 (1.3%) 2 0/104 (0%) 0
    Atrial flutter 1/149 (0.7%) 1 0/104 (0%) 0
    Bradycardia 1/149 (0.7%) 1 0/104 (0%) 0
    Cardiac failure acute 1/149 (0.7%) 1 0/104 (0%) 0
    Coronary artery disease 1/149 (0.7%) 1 0/104 (0%) 0
    Dilatation ventricular 1/149 (0.7%) 1 0/104 (0%) 0
    Eye disorders
    Cogan's syndrome 1/149 (0.7%) 1 0/104 (0%) 0
    Retinal artery occlusion 1/149 (0.7%) 1 0/104 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 3/149 (2%) 3 3/104 (2.9%) 3
    Ileus 2/149 (1.3%) 2 0/104 (0%) 0
    Ascites 1/149 (0.7%) 1 0/104 (0%) 0
    Colitis ulcerative 1/149 (0.7%) 1 0/104 (0%) 0
    Faecal incontinence 1/149 (0.7%) 1 0/104 (0%) 0
    Gastrointestinal haemorrhage 2/149 (1.3%) 2 0/104 (0%) 0
    Haematochezia 1/149 (0.7%) 1 1/104 (1%) 1
    Oesophageal ulcer haemorrhage 1/149 (0.7%) 1 0/104 (0%) 0
    Abdominal Pain 1/149 (0.7%) 2 3/104 (2.9%) 5
    Colitis 3/149 (2%) 3 2/104 (1.9%) 2
    Gastritis haemorrhagic 0/149 (0%) 0 1/104 (1%) 1
    Nausea 0/149 (0%) 0 1/104 (1%) 1
    Obstruction gastric 0/149 (0%) 0 1/104 (1%) 1
    Vomiting 0/149 (0%) 0 1/104 (1%) 1
    Constipation 1/149 (0.7%) 1 0/104 (0%) 0
    Duodenal ulcer 1/149 (0.7%) 1 0/104 (0%) 0
    Intestinal obstruction 1/149 (0.7%) 1 0/104 (0%) 0
    Intestinal ulcer 1/149 (0.7%) 1 0/104 (0%) 0
    Irritable bowel syndrome 1/149 (0.7%) 1 0/104 (0%) 0
    Oesophagitis 1/149 (0.7%) 1 0/104 (0%) 0
    Proctitis 1/149 (0.7%) 1 0/104 (0%) 0
    Faeces discoloured 0/149 (0%) 0 1/104 (1%) 1
    General disorders
    Pyrexia 3/149 (2%) 3 0/104 (0%) 0
    Asthenia 1/149 (0.7%) 1 1/104 (1%) 1
    Gait disturbance 0/149 (0%) 0 1/104 (1%) 1
    Systemic inflammatory response syndrome 0/149 (0%) 0 1/104 (1%) 1
    Death 4/149 (2.7%) 4 0/104 (0%) 0
    Chills 0/149 (0%) 0 1/104 (1%) 1
    Fatigue 0/149 (0%) 0 1/104 (1%) 1
    Hepatobiliary disorders
    Cholecystitis acute 1/149 (0.7%) 1 0/104 (0%) 0
    Cholecystitis 1/149 (0.7%) 1 0/104 (0%) 0
    Cirrhosis alcoholic 1/149 (0.7%) 1 0/104 (0%) 0
    Infections and infestations
    Clostridium difficile infection 6/149 (4%) 11 0/104 (0%) 0
    Pneumonia 8/149 (5.4%) 8 2/104 (1.9%) 2
    Sepsis 8/149 (5.4%) 10 3/104 (2.9%) 3
    Bacteraemia 1/149 (0.7%) 1 0/104 (0%) 0
    Clostridium difficile colitis 3/149 (2%) 3 0/104 (0%) 0
    Klebsiella bacteraemia 1/149 (0.7%) 1 0/104 (0%) 0
    Pyelonephritis 1/149 (0.7%) 1 0/104 (0%) 0
    Urinary tract infection bacterial 1/149 (0.7%) 1 0/104 (0%) 0
    Urinary tract infection 5/149 (3.4%) 6 1/104 (1%) 1
    Cellulitis 2/149 (1.3%) 2 1/104 (1%) 1
    Groin abscess 0/149 (0%) 0 1/104 (1%) 1
    Septic shock 1/149 (0.7%) 1 2/104 (1.9%) 2
    Respiratory tract infection viral 1/149 (0.7%) 1 0/104 (0%) 0
    Salmonellosis 1/149 (0.7%) 1 0/104 (0%) 0
    Injury, poisoning and procedural complications
    Alcohol poisoning 1/149 (0.7%) 1 0/104 (0%) 0
    Fall 2/149 (1.3%) 2 1/104 (1%) 1
    Laceration 1/149 (0.7%) 1 1/104 (1%) 1
    Subdural haematoma 1/149 (0.7%) 1 0/104 (0%) 0
    Wound secretion 1/149 (0.7%) 1 0/104 (0%) 0
    Hip fracture 2/149 (1.3%) 2 1/104 (1%) 1
    Foot fracture 1/149 (0.7%) 2 0/104 (0%) 0
    Arteriovenous fistula aneurysm 1/149 (0.7%) 1 0/104 (0%) 0
    Dialysis related complication 1/149 (0.7%) 1 0/104 (0%) 0
    Excoriation 1/149 (0.7%) 1 0/104 (0%) 0
    Traumatic haematoma 1/149 (0.7%) 1 0/104 (0%) 0
    Investigations
    Troponin increased 2/149 (1.3%) 2 1/104 (1%) 1
    White blood cell count increased 1/149 (0.7%) 1 0/104 (0%) 0
    Blood potassium decreased 0/149 (0%) 0 1/104 (1%) 1
    Vital functions abnormal 0/149 (0%) 0 1/104 (1%) 1
    Electrocardiogram ST segment elevation 1/149 (0.7%) 1 0/104 (0%) 0
    Staphylococcus test positive 1/149 (0.7%) 1 0/104 (0%) 0
    Venous pressure jugular increased 1/149 (0.7%) 1 0/104 (0%) 0
    Inflammatory marker increased 0/149 (0%) 0 1/104 (1%) 1
    Blood lactic acid increased 0/149 (0%) 0 1/104 (1%) 1
    Metabolism and nutrition disorders
    Cachexia 1/149 (0.7%) 1 0/104 (0%) 0
    Hyperglycaemia 1/149 (0.7%) 2 0/104 (0%) 0
    Hyperkalaemia 1/149 (0.7%) 1 0/104 (0%) 0
    Malnutrition 1/149 (0.7%) 1 0/104 (0%) 0
    Dehydration 0/149 (0%) 0 3/104 (2.9%) 3
    Failure to thrive 0/149 (0%) 0 1/104 (1%) 1
    Hypocalcaemia 0/149 (0%) 0 1/104 (1%) 1
    Hypokalaemia 1/149 (0.7%) 1 2/104 (1.9%) 2
    Hypomagnesaemia 1/149 (0.7%) 1 1/104 (1%) 1
    Diabetes mellitus 1/149 (0.7%) 1 0/104 (0%) 0
    Hypoglycaemia 1/149 (0.7%) 1 0/104 (0%) 0
    Lactic acidosis 1/149 (0.7%) 1 0/104 (0%) 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis 1/149 (0.7%) 1 0/104 (0%) 0
    Back pain 0/149 (0%) 0 1/104 (1%) 1
    Arthralgia 1/149 (0.7%) 1 0/104 (0%) 0
    Groin Pain 1/149 (0.7%) 1 0/104 (0%) 0
    Muscular weakness 1/149 (0.7%) 1 0/104 (0%) 0
    Musculoskeletal pain 1/149 (0.7%) 1 0/104 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 1/149 (0.7%) 1 0/104 (0%) 0
    Lung neoplasm malignant 0/149 (0%) 0 1/104 (1%) 1
    Acute myeloid leukaemia 1/149 (0.7%) 1 0/104 (0%) 0
    Hepatic cancer 1/149 (0.7%) 1 0/104 (0%) 0
    Lung adenocarcinoma 1/149 (0.7%) 1 0/104 (0%) 0
    Lung cancer metastatic 1/149 (0.7%) 1 0/104 (0%) 0
    Lymphoma 1/149 (0.7%) 1 0/104 (0%) 0
    Tumour pain 1/149 (0.7%) 1 0/104 (0%) 0
    Uterine cancer 1/149 (0.7%) 1 0/104 (0%) 0
    Nervous system disorders
    Convulsion 1/149 (0.7%) 1 0/104 (0%) 0
    Haemorrhage intracranial 1/149 (0.7%) 1 1/104 (1%) 1
    Toxic encephalopathy 2/149 (1.3%) 2 0/104 (0%) 0
    Syncope 0/149 (0%) 0 2/104 (1.9%) 2
    Hepatic encephalopathy 0/149 (0%) 0 1/104 (1%) 1
    Neuropathy peripheral 0/149 (0%) 0 1/104 (1%) 1
    Tremor 0/149 (0%) 0 1/104 (1%) 1
    Cerebrovascular accident 1/149 (0.7%) 1 0/104 (0%) 0
    Dementia 1/149 (0.7%) 1 0/104 (0%) 0
    Ischaemic stroke 1/149 (0.7%) 1 0/104 (0%) 0
    Parkinson's disease 1/149 (0.7%) 1 0/104 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Hyperemesis gravidarum 1/149 (0.7%) 2 0/104 (0%) 0
    Psychiatric disorders
    Anxiety 1/149 (0.7%) 1 0/104 (0%) 0
    Hallucination 0/149 (0%) 0 1/104 (1%) 1
    Mood altered 0/149 (0%) 0 1/104 (1%) 1
    Suicide attempt 0/149 (0%) 0 1/104 (1%) 1
    Agitation 1/149 (0.7%) 1 0/104 (0%) 0
    Alcohol withdrawal syndrome 1/149 (0.7%) 1 0/104 (0%) 0
    Delirium 1/149 (0.7%) 1 0/104 (0%) 0
    Delirium tremens 1/149 (0.7%) 1 0/104 (0%) 0
    Mental status changes 1/149 (0.7%) 1 0/104 (0%) 0
    Renal and urinary disorders
    Renal failure chronic 3/149 (2%) 3 1/104 (1%) 1
    Calculus ureteric 1/149 (0.7%) 1 0/104 (0%) 0
    Hydronephrosis 1/149 (0.7%) 1 0/104 (0%) 0
    Hydroureter 1/149 (0.7%) 1 0/104 (0%) 0
    Renal failure acute 3/149 (2%) 4 2/104 (1.9%) 2
    Nephrotic syndrome 0/149 (0%) 0 1/104 (1%) 1
    Haematuria 1/149 (0.7%) 1 0/104 (0%) 0
    Hypertonic bladder 1/149 (0.7%) 1 0/104 (0%) 0
    Nephropathy 1/149 (0.7%) 1 0/104 (0%) 0
    Renal artery stenosis 1/149 (0.7%) 1 0/104 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 3/149 (2%) 3 0/104 (0%) 0
    Dyspnoea 3/149 (2%) 6 2/104 (1.9%) 2
    Acute respiratory distress syndrome 1/149 (0.7%) 1 0/104 (0%) 0
    Emphysema 1/149 (0.7%) 1 0/104 (0%) 0
    Pulmonary mass 1/149 (0.7%) 1 0/104 (0%) 0
    Respiratory distress 1/149 (0.7%) 1 1/104 (1%) 1
    Pleural effusion 1/149 (0.7%) 1 1/104 (1%) 1
    Pneumonia aspiration 2/149 (1.3%) 2 1/104 (1%) 1
    Pulmonary oedema 0/149 (0%) 0 1/104 (1%) 1
    Respiratory failure 1/149 (0.7%) 1 1/104 (1%) 1
    Acute respiratory failure 1/149 (0.7%) 1 0/104 (0%) 0
    Skin and subcutaneous tissue disorders
    Skin ulcer 0/149 (0%) 0 1/104 (1%) 1
    Decubitus ulcer 1/149 (0.7%) 1 0/104 (0%) 0
    Social circumstances
    Immobile 1/149 (0.7%) 1 0/104 (0%) 0
    Vascular disorders
    Hypertension 3/149 (2%) 3 0/104 (0%) 0
    Hypertensive crisis 2/149 (1.3%) 3 1/104 (1%) 1
    Hypotension 1/149 (0.7%) 1 1/104 (1%) 1
    Haematoma 0/149 (0%) 0 1/104 (1%) 1
    Aortic dilatation 1/149 (0.7%) 1 0/104 (0%) 0
    Diffuse vasculitis 1/149 (0.7%) 1 0/104 (0%) 0
    Venous insufficiency 0/149 (0%) 0 1/104 (1%) 1
    Other (Not Including Serious) Adverse Events
    RBX2660 Open-label Historical Control Antibiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 118/149 (79.2%) 62/104 (59.6%)
    Gastrointestinal disorders
    Diarrhoea 42/149 (28.2%) 69 8/104 (7.7%) 8
    Abdominal pain 18/149 (12.1%) 30 1/104 (1%) 1
    Flatulence 8/149 (5.4%) 9 1/104 (1%) 1
    Constipation 17/149 (11.4%) 21 4/104 (3.8%) 9
    Abdominal distension 9/149 (6%) 11 1/104 (1%) 2
    Nausea 10/149 (6.7%) 15 2/104 (1.9%) 2
    General disorders
    Fatigue 3/149 (2%) 4 9/104 (8.7%) 9
    Asthenia 4/149 (2.7%) 4 7/104 (6.7%) 8
    Oedema peripheral 2/149 (1.3%) 3 6/104 (5.8%) 11
    Infections and infestations
    Urinary tract infection 17/149 (11.4%) 20 17/104 (16.3%) 22
    Upper respiratory tract infection 8/149 (5.4%) 9 3/104 (2.9%) 3
    Musculoskeletal and connective tissue disorders
    Back pain 7/149 (4.7%) 7 7/104 (6.7%) 10
    Nervous system disorders
    Headache 9/149 (6%) 9 6/104 (5.8%) 7
    Dizziness 2/149 (1.3%) 2 6/104 (5.8%) 7
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 2/149 (1.3%) 2 6/104 (5.8%) 8

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Clinical Development
    Organization Rebiotix, Inc.
    Phone 651-705-8778
    Email US8-StudyInfo@ferring.com
    Responsible Party:
    Rebiotix Inc.
    ClinicalTrials.gov Identifier:
    NCT02589847
    Other Study ID Numbers:
    • 2015-01
    First Posted:
    Oct 28, 2015
    Last Update Posted:
    Mar 26, 2021
    Last Verified:
    Feb 1, 2021