Trial Outcomes & Findings for Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection (NCT NCT05304715)
NCT ID: NCT05304715
Last Updated: 2026-03-04
Results Overview
Unfavorable outcome is defined as the presence of any of: organ dysfunction; CDI relapse; and/or death. Progression into organ dysfunction is defined as any increase of the baseline total SOFA score by at least 2 points. Need for colectomy or admission in the Intensive Care Unit counts also as organ dysfunction. The primary endpoint is tested on Day 40 from start of blind treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
40 days
Results posted on
2026-03-04
Participant Flow
Participant milestones
| Measure |
Placebo
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Bezlotoxumab
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77 years
n=41 Participants
|
84.5 years
n=35 Participants
|
83 years
n=76 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
27 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
17 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
44 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 40 daysPopulation: No patient was lost to follow-up, and all of them were included in the final analysis
Unfavorable outcome is defined as the presence of any of: organ dysfunction; CDI relapse; and/or death. Progression into organ dysfunction is defined as any increase of the baseline total SOFA score by at least 2 points. Need for colectomy or admission in the Intensive Care Unit counts also as organ dysfunction. The primary endpoint is tested on Day 40 from start of blind treatment
Outcome measures
| Measure |
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
The Superiority of Bezlotoxumab Over Placebo to Reduce the Occurence of an Unfavorable Outcome by Day 40.
|
7 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 1-40 daysPopulation: No patient was lost to follow-up, and all of them were included in the final analysis
This is defined as the presentation of organ dysfunction in any of the enrolled patients of each group starting from the day of blind allocation until Day 40.
Outcome measures
| Measure |
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
The Superiority of Bezlotoxumab Over Placebo Regarding the Time to First Organ Dysfunction.
|
20.5 days
Interval 4.0 to 40.0
|
40 days
Interval 29.8 to 40.0
|
SECONDARY outcome
Timeframe: 1-40 daysPopulation: No patient was lost to follow-up, and all of them were included in the final analysis
The relapse of CDI is under daily follow-up until Day 40. Relapse is defined as the return of more than three unformed bowel movements in 24 hours with a positive stool toxin test necessitating retreatment.
Outcome measures
| Measure |
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
The Superiority of Bezlotoxumab Over Placebo to Reduce the Number of Participants Experiencing a CDI Relapse.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-40 daysPopulation: No patient was lost to follow-up, and all of them were included in the final analysis
Death by day 40 from study enrolment
Outcome measures
| Measure |
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
The Superiority of Bezlotoxumab Over Placebo to Reduce the Occurence of Death by Day 40.
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-40 daysPopulation: No patient was lost to follow-up, and all of them were included in the final analysis
This is calculated starting from the day of blind allocation until Day 40
Outcome measures
| Measure |
Bezlotoxumab
n=22 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=22 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
The Superiority of Bezlotoxumab Over Placebo to Reduce the Overall Cost of Hospitalization
|
4,218.30 Euros
Standard Error 938.9
|
1,825.20 Euros
Standard Error 275.5
|
SECONDARY outcome
Timeframe: 1-40 daysPopulation: Group 1 (n=25) is comprised of patients with a high-risk BEYOND score who did not receive treatment with bezlotoxumab. Group 2 (n=56) is comprised of patients with a low-risk BEYOND score who failed the screening process in the trial.
A high-risk BEYOND score is expected to be associated with an increased risk for unfavorable outcome by day40. This is tested by comparing the number of participants to achieve the primary endpoint of unfavorable outcome by day40 between patients who have failed the screening process in the trial because of a low-risk BEYOND score (n=56); patients with a high-risk BEYOND score who were not enrolled in the study because the score was provided more than 72hours after the initiation of the standard-of-care treatment (n = 3); and patients who were enrolled in the trial and allocated to the placebo arm (n=22).
Outcome measures
| Measure |
Bezlotoxumab
n=25 Participants
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Placebo
n=56 Participants
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
Validation of the BEYOND Score
|
19 Participants
|
19 Participants
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 22 other events
Deaths: 10 deaths
Bezlotoxumab
Serious events: 4 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Bezlotoxumab
n=22 participants at risk
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal tract bleeding
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Hepatobiliary disorders
Necrotizing cholecystitis
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Aspiration pneumonia
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Bacteremia
|
18.2%
4/22 • Number of events 4 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Septic shock
|
9.1%
2/22 • Number of events 2 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Fungemia
|
4.5%
1/22 • Number of events 2 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Hyponatremia
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney tumor
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Nervous system disorders
Epileptic seizure
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Renal and urinary disorders
Acute kidney injury dialysis
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure due to COVID-19
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • Number of events 1 • From enrollment untill end of follow up (days 1-40)
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Patients will be treated with 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
Bezlotoxumab
n=22 participants at risk
Patients will be treated with bezlotoxumab at a dose of 10mg per kg of body weight (up to maximum of 1000mg) dissolved in 250ml of normal saline 0.9% or 5% dextrose water as single intravenous infusion of one hour within 72 hours from the start of standard-of-care treatment. Standard-of-care treatment will be prescribed to all patients at the discretion of the attending physicians according to local guidelines or to their own decision.
|
|---|---|---|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Gamma-glutamyl transpeptidase increased
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
4/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Total bilirubin increased
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Troponin increased
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.7%
5/22 • From enrollment untill end of follow up (days 1-40)
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
13.6%
3/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypochloremia
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
31.8%
7/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.9%
9/22 • From enrollment untill end of follow up (days 1-40)
|
22.7%
5/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
4/22 • From enrollment untill end of follow up (days 1-40)
|
13.6%
3/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.8%
7/22 • From enrollment untill end of follow up (days 1-40)
|
27.3%
6/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
|
Metabolism and nutrition disorders
Low uric acid
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Renal and urinary disorders
Acute kidney injury
|
18.2%
4/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Renal and urinary disorders
Hematuria
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
General disorders
Bedsore
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Aspiration pneumonia
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Asymptomatic bacteriuria
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Monoarthritis
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Perianal abscess
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Infections and infestations
Wound infection
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Investigations
Alkaline phosphatase increased
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Cardiac disorders
Chest pain
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Cardiac disorders
Tachycardia
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.7%
5/22 • From enrollment untill end of follow up (days 1-40)
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
6/22 • From enrollment untill end of follow up (days 1-40)
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
|
Blood and lymphatic system disorders
INR prolongation
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
9.1%
2/22 • From enrollment untill end of follow up (days 1-40)
|
|
Blood and lymphatic system disorders
Low fibrinogen
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Respiratory, thoracic and mediastinal disorders
Solitary pulmonary nodule
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • From enrollment untill end of follow up (days 1-40)
|
0.00%
0/22 • From enrollment untill end of follow up (days 1-40)
|
Additional Information
Evangelos J. Giamarellos-Bourboulis
Hellenic Institute for the Study of Sepsis and 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Phone: +302107480662
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place