Trial Outcomes & Findings for Molecular Epidemiology of Clostridium Difficile Infections in Children (NCT NCT01957761)
NCT ID: NCT01957761
Last Updated: 2016-02-23
Results Overview
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.
COMPLETED
132 participants
On day 1 of diagnosis of Clostridium difficile infection
2016-02-23
Participant Flow
Participant milestones
| Measure |
Clostridium Difficile Infection
All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
189
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Molecular Epidemiology of Clostridium Difficile Infections in Children
Baseline characteristics by cohort
| Measure |
Clostridium Difficile Infection
n=189 Participants
All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
|
|---|---|
|
Age, Categorical
<=18 years
|
176 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
9 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=99 Participants
|
|
Number of cases of BI/NAP1/027
|
3 cases
n=99 Participants
|
PRIMARY outcome
Timeframe: On day 1 of diagnosis of Clostridium difficile infectionStool 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.
Outcome measures
| Measure |
Clostridium Difficile Infection
n=189 Participants
All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
|
|---|---|
|
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis
|
3 cases of BI/NAP1/027
|
Adverse Events
Clostridium Difficile Infection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Larry Kociolek, MD, MSCI
Ann & Robert H. Lurie Children's Hospital of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place