Trial Outcomes & Findings for Understanding Childhood Infection, Inflammation and Allergy (NCT NCT01022268)
NCT ID: NCT01022268
Last Updated: 2022-11-21
Results Overview
number of participants with phenotype of definite bacterial or definite viral disease, based on culture or molecular investigations of samples from a sterile site
Recruitment status
COMPLETED
Target enrollment
902 participants
Primary outcome timeframe
Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days
Results posted on
2022-11-21
Participant Flow
Participant milestones
| Measure |
Infection, Inflammation or Allergy
Children presenting via any means to St Mary's Hospital; this would include the A\&E department, the general and infectious disease wards and the paediatric intensive care unit.
Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process
|
Controls
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons
|
|---|---|---|
|
Overall Study
STARTED
|
818
|
84
|
|
Overall Study
COMPLETED
|
816
|
84
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Infection, Inflammation or Allergy
Children presenting via any means to St Mary's Hospital; this would include the A\&E department, the general and infectious disease wards and the paediatric intensive care unit.
Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process
|
Controls
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Understanding Childhood Infection, Inflammation and Allergy
Baseline characteristics by cohort
| Measure |
Infection, Inflammation or Allergy
n=818 Participants
Children presenting via any means to St Mary's Hospital; this would include the A\&E department, the general and infectious disease wards and the paediatric intensive care unit.
Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process
|
Controls
n=84 Participants
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons
|
Total
n=902 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age at recruitment · <2 years
|
467 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Age, Customized
Age at recruitment · >2 years
|
265 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Age, Customized
Age at recruitment · age not available
|
86 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex/Gender, Customized
gender · male
|
318 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Sex/Gender, Customized
gender · female
|
244 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex/Gender, Customized
gender · not known
|
256 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Asian
|
63 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Black
|
85 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Mixed race
|
32 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Other
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · White
|
273 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Declined
|
71 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ethnicity · Ethnicity not available
|
264 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Number of participants with samples taken from sterile site for culture or molecular diagnosis
|
818 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
902 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 daysPopulation: Controls did not present with infectious, inflammatory or allergic conditions - and therefore all patients under the control category had a phenotype of 'healthy' - with none of them meeting criteria for the other phenotype groups (bacterial, viral, inflammatory, uncertain, other).
number of participants with phenotype of definite bacterial or definite viral disease, based on culture or molecular investigations of samples from a sterile site
Outcome measures
| Measure |
Infection, Inflammation or Allergy
n=818 Participants
Children presenting via any means to St Mary's Hospital; this would include the A\&E department, the general and infectious disease wards and the paediatric intensive care unit.
Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process
|
Controls
n=84 Participants
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons
|
|---|---|---|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Uncertain phenotype
|
450 Participants
|
0 Participants
|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Other phenotype
|
40 Participants
|
0 Participants
|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Definite bacterial phenotype
|
123 Participants
|
0 Participants
|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Definite viral phenotype
|
164 Participants
|
0 Participants
|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Inflammatory phenotype
|
41 Participants
|
0 Participants
|
|
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
Healthy controls
|
0 Participants
|
84 Participants
|
Adverse Events
Infection, Inflammation or Allergy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place