18 and older, any sex, with Infections, Clostridium Difficile. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14Primary· 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.
Group
Value
95% CI
Recurrence Group
2083.3
995.8 – 4358.5
Sustained Response Group
3189.4
1338.4 – 7600.2
Unclassified Group
32096.4
26.1 – 39518495
Serum F2 C-terminal Anti-toxin B Antibody ConcentrationsPrimary· At Day 14
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.
Group
Value
95% CI
Recurrence Group
149.3
20.2 – 1102.9
Sustained Response Group
246.6
52.7 – 1154.8
Unclassified Group
10736.7
1.7 – 69276208
Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72Secondary· At Day 0 and at 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.
Anti-toxin B at Day 0
Group
Value
95% CI
Recurrence Group
1939.6
847.2 – 4440.6
Sustained Response Group
1682.9
858.7 – 3298.2
Unclassified Group
19638.5
217.5 – 1773406
Anti-toxin B at Day 72
Group
Value
95% CI
Recurrence Group
4471.1
1441.1 – 13871.8
Sustained Response Group
3670.4
1519.8 – 8864.6
Unclassified Group
64050.6
NA – NA
Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14Secondary· 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.
Neutralizing anti-toxin A
Group
Value
95% CI
Recurrence Group
11.3
0.7 – 194.8
Sustained Response Group
2.3
1.2 – 4.5
Unclassified Group
4.7
0.0 – 1584000000
Neutralizing anti-toxin B
Group
Value
95% CI
Recurrence Group
2.7
0.4 – 18.2
Sustained Response Group
15.3
4.2 – 55.1
Unclassified Group
1725.7
125.5 – 23728.0
Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 0, Within 10 Days After Recurrence and at Day 72Secondary· At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (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.
Neutralizing anti-toxin A, Day 0
Group
Value
95% CI
Recurrence Group
14.8
0.4 – 525.0
Sustained Response Group
1.5
0.9 – 2.4
Unclassified Group
3.2
0.0 – 7130211
Neutralizing anti-toxin A, recurrence 1
Group
Value
95% CI
Recurrence Group
12.2
0.6 – 241.2
Sustained Response Group
1.0
NA – NA
Neutralizing anti-toxin A, recurrence 2
Group
Value
95% CI
Recurrence Group
1.0
NA – NA
Neutralizing anti-toxin A, Day 72
Group
Value
95% CI
Recurrence Group
11.1
0.3 – 422.0
Sustained Response Group
2.5
1.2 – 5.4
Neutralizing anti-toxin B, Day 0
Group
Value
95% CI
Recurrence Group
3.3
0.4 – 28.0
Sustained Response Group
9.6
2.7 – 34.1
Unclassified Group
340.3
0.0 – 461890000
Neutralizing anti-toxin B, recurrence 1
Group
Value
95% CI
Recurrence Group
3.0
0.4 – 22.3
Sustained Response Group
1.0
NA – NA
Neutralizing anti-toxin B, recurrence 2
Group
Value
95% CI
Recurrence Group
1.0
NA – NA
Neutralizing anti-toxin B, Day 72
Group
Value
95% CI
Recurrence Group
8.0
1.1 – 56.8
Sustained Response Group
16.2
4.3 – 60.3
Unclassified Group
1372.0
NA – NA
Number of Subjects With Clostridium Difficile Infection (CDI) RecurrenceSecondary· From Day 0 to Day 72
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.
Group
Value
95% CI
Recurrence Group
7
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
CDI Initial Episodes Severity Characteristics, in All SubjectsSecondary· At Day 0
Severity characteristics were expressed in duration of days for hospitalization, intensive care unit, Standard of Care (SoC) and CDI episodes.
Duration of hospitalization
Group
Value
95% CI
Sustained Response Group
5.0
4.0 – 11.0
Failure to Antibiotic Group
7.0
7.0 – 7.0
Unclassified Group
16.0
8.0 – 22.0
Duration in intensive care unit
Group
Value
95% CI
Sustained Response Group
5.0
4.0 – 6.0
Unclassified Group
8.0
7.0 – 17.0
Duration of CDI episodes
Group
Value
95% CI
Recurrence Group
10.5
9.0 – 15.0
Sustained Response Group
6.0
4.0 – 13.0
Failure to Antibiotic Group
24.0
14.5 – 33.5
Unclassified Group
10.0
5.0 – 15.0
Duration of SoC
Group
Value
95% CI
Recurrence Group
11.0
11.0 – 15.0
Sustained Response Group
14.0
11.0 – 16.0
Failure to Antibiotic Group
34.0
11.0 – 84.0
Unclassified Group
11.0
10.0 – 26.0
Number of Subjects With Initial CDI Episode by Severity, in All SubjectsSecondary· At Day 0
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).
Medical attention - Medical contact without visit
Group
Value
95% CI
Recurrence Group
1
Sustained Response Group
1
Failure to Antibiotic Group
1
Unclassified Group
0
Medical attention - Medical personnel visit
Group
Value
95% CI
Recurrence Group
2
Sustained Response Group
3
Failure to Antibiotic Group
1
Unclassified Group
0
Medical attention - Emergency Room
Group
Value
95% CI
Recurrence Group
2
Sustained Response Group
6
Failure to Antibiotic Group
1
Unclassified Group
1
Medical attention - Hospitalization
Group
Value
95% CI
Recurrence Group
2
Sustained Response Group
15
Failure to Antibiotic Group
2
Unclassified Group
8
Intensive care unit - Yes
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
3
Failure to Antibiotic Group
0
Unclassified Group
3
Intensive care unit - No
Group
Value
95% CI
Recurrence Group
7
Sustained Response Group
22
Failure to Antibiotic Group
5
Unclassified Group
6
Colectomy - Yes
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
Colectomy - No
Group
Value
95% CI
Recurrence Group
7
Sustained Response Group
25
Failure to Antibiotic Group
5
Unclassified Group
9
Number of Subjects With CDI Recurrence by Severity, in Those Subjects Who RecurSecondary· At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant
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.
Non-severe
Group
Value
95% CI
Recurrence Group
7
Severe
Group
Value
95% CI
Recurrence Group
0
Number of Subjects With Failure of Antibiotic TreatmentSecondary· Within 3 months before the initial CDI episodes
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
1st Generation Cephalosporin
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
2
Failure to Antibiotic Group
1
Unclassified Group
0
1st Gen Cephalosporin+Tetracyclin, no Tigecyclin
Group
Value
95% CI
Recurrence Group
1
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
3rd Generation Cephalosporin, no Ceftazidime
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
1
Failure to Antibiotic Group
0
Unclassified Group
0
4th Generation Cephalosporin and Fluoroquinolone
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
1
Failure to Antibiotic Group
0
Unclassified Group
0
Aminopenicillin
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
3
Failure to Antibiotic Group
0
Unclassified Group
0
Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin
Group
Value
95% CI
Recurrence Group
1
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin
Group
Value
95% CI
Recurrence Group
1
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
Aminopen+BetaLactam Inhib and Fluoroquinolone
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
1
Number of Subjects With Risk Factors Associated With the Initial CDI EpisodeSecondary· At Day 0
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
Setting of CDI development: Community
Group
Value
95% CI
Recurrence Group
5
Sustained Response Group
18
Failure to Antibiotic Group
3
Unclassified Group
2
Setting of CDI development: Hospital
Group
Value
95% CI
Recurrence Group
2
Sustained Response Group
6
Failure to Antibiotic Group
1
Unclassified Group
6
Setting of CDI development: Nursing home
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
Setting of CDI development: Rehabilitation center
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
0
Failure to Antibiotic Group
0
Unclassified Group
0
Setting of CDI development: Other
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
1
Failure to Antibiotic Group
1
Unclassified Group
1
No CDI episodes within 6 months
Group
Value
95% CI
Recurrence Group
6
Sustained Response Group
22
Failure to Antibiotic Group
4
Unclassified Group
8
CDI episodes within 6 months
Group
Value
95% CI
Recurrence Group
1
Sustained Response Group
3
Failure to Antibiotic Group
1
Unclassified Group
1
No admission to hospital within 3 months
Group
Value
95% CI
Recurrence Group
6
Sustained Response Group
15
Failure to Antibiotic Group
4
Unclassified Group
4
Number of Subjects With Risk Factors Associated With the CDI RecurrenceSecondary· At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant
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).
Setting of CDI development: Community
Group
Value
95% CI
Recurrence Group
6
Setting of CDI development: Hospital
Group
Value
95% CI
Recurrence Group
1
Setting of CDI development: Nursing home
Group
Value
95% CI
Recurrence Group
0
Setting of CDI development: Rehabilitation center
Group
Value
95% CI
Recurrence Group
0
Sustained Response Group
0
Setting of CDI development: Other
Group
Value
95% CI
Recurrence Group
0
No admission to hospital during follow-up period
Group
Value
95% CI
Recurrence Group
7
Admission to hospital during follow-up period
Group
Value
95% CI
Recurrence Group
0
Not staying in nursing home during FU period
Group
Value
95% CI
Recurrence Group
7
Sponsor's own description
This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 7 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01716533.