BIVA Studies vs Controls for BIVA Studies: Number of Participants With Clinically-assigned Retrospective Phenotype
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.11 | 0.102 | 0.118 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0.000000000000000000217 | 0.00297 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.11 | 0.102 | 0.118 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one more participant with the outcome on BIVA Studies than on Controls for BIVA Studies | 9.09 | 8.46 | 9.82 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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 | 655 | 5,952 | OG000 | ClinicalTrials.gov |
| Group 2 | Controls for BIVA Studies | 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 | 0 | 1,290 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With Clinically-assigned Retrospective Phenotype | ClinicalTrials.gov |
| Description | Clinically-assigned retrospective phenotype, according to the cause of illness | ClinicalTrials.gov |
| Time frame | Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days | ClinicalTrials.gov |
| Population | Number of children with definite bacterial illness assessed by positive blood culture and/or positive culture of sample from sterile site | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM) | ClinicalTrials.gov |
| NCT number | NCT03502993 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Fever, Infection, Inflammation | ClinicalTrials.gov |
| Interventions | Validation of biomarker | ClinicalTrials.gov |
| Lead sponsor | Imperial College London | ClinicalTrials.gov |
| Results first posted | 2023-10-13 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03502993?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.