| Primary | Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14 | Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of the considered assay was available for the blood sample taken at Day 14. The development of the serum anti-toxin A ELISA was cancelled, therefore this analysis was not performed. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. | | OG003 | Unclassified Group | Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002083.3(995.8 to 4358.5)
- OG0013189.4(1338.4 to 7600.2)
- OG00332096.4(26.1 to 39518495)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration. | ANOVA | ANOVA model -pooled variance. | 0.5746 | P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05. | GMC ratio | 1.53 | | | 2-Sided | 95 | 0.33 | 7.14 | | | GMC ratio = GMC Sustained response Group /GMC Recurrence Group. | | |
|
| Primary | Serum F2 C-terminal Anti-toxin B Antibody Concentrations | Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of the considered assay was available for the blood sample taken at Day 14. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72 | Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off equal to or above (≥) 100 EU/mL. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of at least one assay was available for the blood sample taken at Day 72. The development of the serum anti-toxin A ELISA was cancelled, therefore this analysis was not performed. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Day 0 and at Day 72 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | |
|
| Secondary | Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14 | Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of at least one assay was available for the blood sample taken at Day 14. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 0, Within 10 Days After Recurrence and at Day 72 | Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization. This measure concerned only diarrhea recurrence. No CDI recurrence was considered as part of the Group Sustained Response. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom the result for the considered assay was available for the blood sample taken at the considered time point. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (Day 72) | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrolment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrolment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence | A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode. | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study. | Posted | | Count of Participants | | Participants | | From Day 0 to Day 72 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrolment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. | |
|
| Secondary | CDI Initial Episodes Severity Characteristics, in All Subjects | Severity characteristics were expressed in duration of days for hospitalization, intensive care unit, Standard of Care (SoC) and CDI episodes. | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study and who reported any of the characteristics assessed. | Posted | | Median | Inter-Quartile Range | Days | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. | |
|
| Secondary | Number of Subjects With Initial CDI Episode by Severity, in All Subjects | Initial CDI episodes were recorded by severity criteria: medical attention given, admission to intensive care unit, colectomy, death, high white blood cells (WBC) count, high creatinine count, hypotension/shock, clinical response to Standard of Care (SoC). | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group | Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Number of Subjects With CDI Recurrence by Severity, in Those Subjects Who Recur | A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode. An episode of diarrhea was not considered as a recurrence of CDI if the stool was negative for C. difficile or if the diarrhea was attributed to another cause than C. difficile. The severity criteria for CDI recurrent episodes were categorized into non-severe and severe. | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study who recurred. | Posted | | Count of Participants | | Participants | | At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrolment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 |
|
| Secondary | Number of Subjects With Failure of Antibiotic Treatment | Failure of antibiotic treatment against C. difficile is defined as the persistence or the incomplete resolution of symptoms (more than one unformed stool per day) after a full course of antibiotic(s) therapy (minimum 7 days). Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin. Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone. Aminopen+BetaLactam Inhib and Fluoroquinolone = Aminopenicillin+Beta-Lactamase Inhibitor and Fluoroquinolone. Antipseudom Pen+BetaLactam Inhib and Cephalosporin = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone and Glycopeptides (Iv). Antipseudom Pen+BetaLactam Inhib and Glycopeptides = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and Glycopeptides (Iv). | The analysis was performed on the Total enrolled cohort, which included all evaluable subjects for whom results about failure of antibiotic treatment (not prescribed to treat Clostridium difficile) were available within 3 months before the initial CDI episodes. | Posted | | Count of Participants | | Participants | | Within 3 months before the initial CDI episodes | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Number of Subjects With Risk Factors Associated With the Initial CDI Episode | Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures). CDI episodes within 6 months: Protocol exclusion criteria for enrolment allowed up to maximum 25% of the planned subjects having a previous CDI episode within the previous 6 months. Antibiotic taken within 3 months: Antibiotic not prescribed to treat C. difficile taken within 3 months before the current CDI episode. | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. |
|
| Secondary | Number of Subjects With Risk Factors Associated With the CDI Recurrence | Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures). | The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study who recurred. | Posted | | Count of Participants | | Participants | | At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant | | | | ID | Title | Description |
|---|
| OG000 | Recurrence Group | Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode. | | OG001 | Sustained Response Group | Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode. | | OG002 | Failure to Antibiotic Group |
|