Trial Outcomes & Findings for Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (NCT NCT03931941)
NCT ID: NCT03931941
Last Updated: 2024-08-07
Results Overview
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
793 participants
Primary outcome timeframe
Up to 6 months after last study treatment.
Results posted on
2024-08-07
Participant Flow
Recruitment was from July 2019 to July 2023 at 56 sites in the US and Canada. Recruitment was performed by trained investigators and study coordinators.
A total of 793 participants were enrolled/signed informed consent of which 95 were screen failures. 698 subjects were enrolled and were not screen failures. One participant was enrolled but not treated, therefore 697 participants received a dose of RBX2660.
Participant milestones
| Measure |
Active
RBX2660 is an enema of a microbiota suspension
RBX2660: RBX2660 is a microbiota suspension administered as an enema
|
|---|---|
|
Overall Study
STARTED
|
698
|
|
Overall Study
COMPLETED
|
635
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Baseline characteristics by cohort
| Measure |
RBX2660
n=697 Participants
RBX2660 is a rectally administered microbiota suspension
RBX2660: RBX2660 is a microbiota suspension administered rectally
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
359 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
338 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 17.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
487 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
670 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
654 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
117 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
580 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after last study treatment.Population: Safety
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
Outcome measures
| Measure |
Active Treatment
n=697 Participants
1 enema of RBX2660
|
|---|---|
|
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
|
697 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after completing the study treatmentPopulation: Modified Intent-to-Treat (MITT)
The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.
Outcome measures
| Measure |
Active Treatment
n=676 Participants
1 enema of RBX2660
|
|---|---|
|
Efficacy of RBX2660 Measured at 8 Weeks After Treatment.
|
499 Participants
|
SECONDARY outcome
Timeframe: 6 months after completing the study treatmentPopulation: Modified Intent-to-Treat
Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment.
Outcome measures
| Measure |
Active Treatment
n=499 Participants
1 enema of RBX2660
|
|---|---|
|
Sustained Clinical Response Through 6 Months After Treatment.
|
454 Participants
|
Adverse Events
Active
Serious events: 87 serious events
Other events: 265 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Active
n=697 participants at risk
RBX2660 is an enema of a microbiota suspension
RBX2660: RBX2660 is a microbiota suspension administered as an enema
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.43%
3/697 • Number of events 3 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Angina pectoris
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac failure
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Congenital, familial and genetic disorders
Spina bifida
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
3/697 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestingal haemorrhage
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
General disorders
Pyrexia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cardiac cirrhosis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Clostridium difficile infection
|
3.0%
21/697 • Number of events 25 • 6 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.86%
6/697 • Number of events 7 • 6 months
|
|
Infections and infestations
Urosepsis
|
0.43%
3/697 • Number of events 3 • 6 months
|
|
Infections and infestations
Diverticulitis
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Clostridial sepsis
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Sepsis
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Septic shock
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Bacteraemia
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Infections and infestations
Cellulitis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Colonic abcess
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Corona virus infection
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Device related infection
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Infected bite
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Osteomylitis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia klebsiella
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Pulmonary sepsis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Streptococcal endocarditis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Post-tramatic pain
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Subarachnoid hemorrhage
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Alcoholic ketoacidosis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Nervous system disorders
Cerebrolvascular accident
|
0.43%
3/697 • Number of events 3 • 6 months
|
|
Nervous system disorders
Encephalopathy
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
2/697 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Alcoholism
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Mental disorder
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.72%
5/697 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.57%
4/697 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Colostomy
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Spinal nerve stimulator implantation
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypotension
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Vascular disorders
Shock
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.29%
2/697 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Ketosis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Nervous system disorders
Quadraparesis
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Nervous system disorders
Spinal cord compression
|
0.14%
1/697 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.14%
1/697 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Active
n=697 participants at risk
RBX2660 is an enema of a microbiota suspension
RBX2660: RBX2660 is a microbiota suspension administered as an enema
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
19.4%
135/697 • Number of events 172 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
94/697 • Number of events 116 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
8.8%
61/697 • Number of events 72 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
45/697 • Number of events 59 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
39/697 • Number of events 46 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
5.3%
37/697 • Number of events 46 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
5.9%
41/697 • Number of events 49 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60