Clostridium Difficile Infections
Conditions
Brief summary
Objectives: 1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area. 2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children. 3. Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.
Interventions
None listed
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clostridium Difficile infection
Exclusion criteria
* Age \< 1 year * Age \> 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis | On day 1 of diagnosis of Clostridium difficile infection | Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clostridium Difficile Infection All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed. | 189 |
| Total | 189 |
Baseline characteristics
| Characteristic | Clostridium Difficile Infection |
|---|---|
| Age, Categorical <=18 years | 176 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 9 years |
| Number of cases of BI/NAP1/027 | 3 cases |
| Region of Enrollment United States | 189 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 189 |
| serious Total, serious adverse events | 0 / 189 |
Outcome results
Primary
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis
Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.
Time frame: On day 1 of diagnosis of Clostridium difficile infection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clostridium Difficile Infection | Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis | 3 cases of BI/NAP1/027 |