Trial Outcomes & Findings for Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM) (NCT NCT03502993)
NCT ID: NCT03502993
Last Updated: 2023-10-13
Results Overview
Clinically-assigned retrospective phenotype, according to the cause of illness
Recruitment status
COMPLETED
Target enrollment
7247 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
2023-10-13
Participant Flow
Participant milestones
| Measure |
BIVA Studies
A minimum of 3,000 children will be recruited to the BIVA-ED study, in order to capture sufficient children with confirmed bacterial infection. Additional children with less common febrile illnesses will also be recruited: 500 critically ill (BIVA-PIC); 200 at high-risk of bacterial illness through primary or secondary immunodeficiency (BIVA-HR); 150 with an inflammatory diagnosis, whose initial presentation is difficult to discriminate from bacterial infection (BIVA-INF). Samples collected from recruits in the BIVA studies will be used for the validation of biomarkers (clinical, proteomic and transcriptomic biomarkers) for diagnosis of febrile illness, including markers of bacterial and viral infection (confirmed by culture and/or molecular microbiology) and inflammatory conditions.
Validation of biomarker
|
Control Children Without Fever or Suspicion of Infection
Children attending hospital for reasons other than for investigation of febrile illness or suspicion of infection
|
|---|---|---|
|
Overall Study
STARTED
|
5957
|
1290
|
|
Overall Study
COMPLETED
|
5957
|
1290
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants excluded from age analysis if data missing or incomplete
Baseline characteristics by cohort
| Measure |
BIVA Studies
n=5957 Participants
A minimum of 3,000 children will be recruited to the BIVA-ED study, in order to capture sufficient children with confirmed bacterial infection. Additional children with less common febrile illnesses will also be recruited: 500 critically ill (BIVA-PIC); 200 at high-risk of bacterial illness through primary or secondary immunodeficiency (BIVA-HR); 150 with an inflammatory diagnosis, whose initial presentation is difficult to discriminate from bacterial infection (BIVA-INF). Samples collected from recruits in the BIVA studies will be used for the validation of biomarkers (clinical, proteomic and transcriptomic biomarkers) for diagnosis of febrile illness, including markers of bacterial and viral infection (confirmed by culture and/or molecular microbiology) and inflammatory conditions.
Validation of biomarker
|
Controls for BIVA Studies
n=1290 Participants
Age-matched control patients will not have had a febrile illness, major trauma or vaccination within the previous three weeks and who are having routine blood sampling for reasons other than investigation of infectious or inflammatory disease.
Control children may include critically ill children without infection or those with healthcare associated infections.
Where data was incomplete, patients were not included in the analysis - therefore the number analysed is not always 1290
|
Total
n=7247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
age on presentation
|
4.57 years
n=5924 Participants • Participants excluded from age analysis if data missing or incomplete
|
9.64 years
n=1231 Participants • Participants excluded from age analysis if data missing or incomplete
|
5.32 years
n=7155 Participants • Participants excluded from age analysis if data missing or incomplete
|
|
Sex: Female, Male
Female
|
2638 Participants
n=5957 Participants • Participants excluded from sex analysis if data missing or incomplete
|
544 Participants
n=1239 Participants • Participants excluded from sex analysis if data missing or incomplete
|
3182 Participants
n=7196 Participants • Participants excluded from sex analysis if data missing or incomplete
|
|
Sex: Female, Male
Male
|
3319 Participants
n=5957 Participants • Participants excluded from sex analysis if data missing or incomplete
|
695 Participants
n=1239 Participants • Participants excluded from sex analysis if data missing or incomplete
|
4014 Participants
n=7196 Participants • Participants excluded from sex analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · North/Mid/East European
|
2999 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
718 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
3717 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · South European
|
1209 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
384 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
1593 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Mandinka
|
194 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
194 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · unknown
|
146 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
146 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Roma European
|
115 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
2 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
117 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Mixed
|
110 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
17 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
127 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · FULA
|
97 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
97 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Gambian
|
93 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
93 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Arabian Peninsula/Arab Middle East
|
91 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
9 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
100 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · West Asian
|
88 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
11 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
99 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · WOLOF
|
70 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
70 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · North African
|
67 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
7 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
74 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · East Asian
|
61 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
21 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
82 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · other
|
46 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
9 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
55 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Serahule
|
45 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
45 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Afro-Carribean
|
31 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
5 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
36 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · South East Asian
|
30 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
1 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
31 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Native South American
|
18 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
3 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
21 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Other African
|
13 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
10 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
23 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Other EU
|
8 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
1 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
9 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Other Asian
|
3 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
3 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
6 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · South Asian Nepal
|
3 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
3 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Jewish
|
7 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
0 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
7 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · South Asian Indian, Pakistani, Bangladeshi
|
170 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
20 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
190 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Subsaharan Africa
|
112 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
9 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
121 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Race/Ethnicity, Customized
reported ethnicity/race · Turkish
|
44 Participants
n=5870 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
7 Participants
n=1237 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
51 Participants
n=7107 Participants • Participants excluded from race/ethnicity analysis if data missing or incomplete
|
|
Co-morbidities leading to increased infection risk, BIVA studies
|
446 participants
n=5957 Participants • Participants excluded from Co-morbidities leading to increased infection risk, BIVA studies analysis if data missing or incomplete
|
43 participants
n=1250 Participants • Participants excluded from Co-morbidities leading to increased infection risk, BIVA studies analysis if data missing or incomplete
|
489 participants
n=7207 Participants • Participants excluded from Co-morbidities leading to increased infection risk, BIVA studies analysis if data missing or incomplete
|
PRIMARY outcome
Timeframe: Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 daysPopulation: Number of children with definite bacterial illness assessed by positive blood culture and/or positive culture of sample from sterile site
Clinically-assigned retrospective phenotype, according to the cause of illness
Outcome measures
| Measure |
BIVA Studies
n=5952 Participants
A minimum of 3,000 children will be recruited to the BIVA-ED study, in order to capture sufficient children with confirmed bacterial infection. Additional children with less common febrile illnesses will also be recruited: 500 critically ill (BIVA-PIC); 200 at high-risk of bacterial illness through primary or secondary immunodeficiency (BIVA-HR); 150 with an inflammatory diagnosis, whose initial presentation is difficult to discriminate from bacterial infection (BIVA-INF). Samples collected from recruits in the BIVA studies will be used for the validation of biomarkers (clinical, proteomic and transcriptomic biomarkers) for diagnosis of febrile illness, including markers of bacterial and viral infection (confirmed by culture and/or molecular microbiology) and inflammatory conditions.
Validation of biomarker
|
Controls for BIVA Studies
n=1290 Participants
Age-matched control patients will not have had a febrile illness, major trauma or vaccination within the previous three weeks and who are having routine blood sampling for reasons other than investigation of infectious or inflammatory disease.
Control children may include critically ill children without infection or those with healthcare associated infections.
Where data was incomplete, patients were not included in the analysis - therefore the number analysed is not always 1290
|
|---|---|---|
|
Number of Participants With Clinically-assigned Retrospective Phenotype
|
655 Participants
|
0 Participants
|
Adverse Events
BIVA Studies
Serious events: 120 serious events
Other events: 0 other events
Deaths: 50 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIVA Studies
n=5957 participants at risk
A minimum of 3,000 children will be recruited to the BIVA-ED study, in order to capture sufficient children with confirmed bacterial infection. Additional children with less common febrile illnesses will also be recruited: 500 critically ill (BIVA-PIC); 200 at high-risk of bacterial illness through primary or secondary immunodeficiency (BIVA-HR); 150 with an inflammatory diagnosis, whose initial presentation is difficult to discriminate from bacterial infection (BIVA-INF). Samples collected from recruits in the BIVA studies will be used for the validation of biomarkers (clinical, proteomic and transcriptomic biomarkers) for diagnosis of febrile illness, including markers of bacterial and viral infection (confirmed by culture and/or molecular microbiology) and inflammatory conditions.
Validation of biomarker
|
Healthy Controls
n=1290 participants at risk
Children attending hospital for reasons other than investigation of febrile illness or suspicion of infection
|
|---|---|---|
|
Blood and lymphatic system disorders
Sepsis syndrome
|
2.0%
120/5957 • Number of events 120 • Participants were monitored for adverse outcomes throughout their stay in hospital and monitored upto follow up period of 10 days
Observational study; outcome (death)
|
0.00%
0/1290 • Participants were monitored for adverse outcomes throughout their stay in hospital and monitored upto follow up period of 10 days
Observational study; outcome (death)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place