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NCT01716533 · ClinicalTrials.gov registry record · NA
Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT01716533: Completed NA study, sponsored by GlaxoSmithKline.
NCT01716533 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01716533, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE Blood sampling
- OTHER Stool sample collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-02-02 |
| Est. Completion | 2015-06-01 |
| Phase | NA |
What the finished NCT01716533 record still lists
NCT01716533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Blood sampling is the first listed.
NCT01716533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01716533 about?
NCT01716533 is a clinical study titled "Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)". 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.
What is the current status of trial NCT01716533?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2013-02-02. Estimated completion is 2015-06-01.
What interventions are being tested in trial NCT01716533?
The interventions under investigation include: Blood sampling (PROCEDURE), Stool sample collection (OTHER).
Who is sponsoring clinical trial NCT01716533?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01716533's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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