Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
NCT07917325, Not applicable, Not yet recruiting, University Hospital, Angers
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis | ClinicalTrials.gov |
| NCT number | NCT07917325 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 240 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Angers | ClinicalTrials.gov |
| Conditions | Infective Endocarditis (IE) | ClinicalTrials.gov |
| Interventions | Blood sample | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Metabolomic signature | Day 1 and Day 5 after enrollement | The existence of a metabolic signature will be confirmed by the presence of a latent variable predictive of cardiac involvement in the study population. This variable will be selected after comparing the metabolic profiles between the 'confirmed EI' group and the Bacteremia Without Cardiac Involvement (BaSAC) group for each time point considered (Day 1 and Day 5). To avoid overfitting, the predictive ability of the multivariate model (orthogonal partial least squares in the context of discriminant analysis, or OPLS-DA) will be evaluated using "standard" criteria as implemented in the SIMCA software, with a low prediction error rate (Q2Ycum ≥ 0.5) and performance significantly superior to that of the random model (P-value (CV-ANOVA) ≤ 0.05, Q2Ycum from the permutation test \< 0). | ClinicalTrials.gov |
| Secondary | Identify potential biomarkers (BM) that can distinguish patients with BaSAC from those with EI. | Day 1 and Day 5 after enrollement | Metabolites, as well as the ratio(s) or sum(s) of metabolites, with a median value that is significantly different between the two groups (BaSAC and EI) will be considered potential BMs for EI, after adjusting for potential sources of confounding (center, germ, etc.) and after correcting for Type I error inflation. The potential BM(s) may or may not be part of the metabolomic signature (see Primary Objective), as applicable. | ClinicalTrials.gov |
| Secondary | Describe changes in the metabolic signature in patients with endocarditis 5 days and 3 months after enrollment and correlate these changes with the diagnosis of IE. | Day 1, Day 5, and Month 3 after enrollment | Proportion of patients in the endocarditis group in whom normalization of the metabolic signature was observed during follow-up (Day 5). Comparison of metabolite concentrations in the same patient across samples collected on Day 1, Day 5, and Month 3 to identify statistically significant changes in the levels of metabolites of interest. Normalization defined as a correlation with the normalization of clinical, laboratory, and microbiological parameters. | ClinicalTrials.gov |
| Secondary | Diagnostic performance of the identified biomarker(s) in a subset of patients with "possible" endocarditis according to the Duke classification revised by the ISCVID in 2023. | Day 1, Day 5, and Month 3 after enrollment | Calculation of sensitivity, specificity, positive predictive value, and negative predictive value of the identified biomarker(s) for the diagnosis of infective endocarditis at each time point considered (Day 1, Day 5, and Month 3). A panel of experts will serve as the gold standard for the diagnosis of infective endocarditis. | ClinicalTrials.gov |
| Secondary | Conduct a sensitivity analysis on the correct classification of patients as "definite IE" according to the Duke classification revised by the ISCVID in 2023 by comparing it with the Duke and Li classification. | Month 3 after enrollment | calculation of the proportion of discordant cases between "definite IE" cases according to the Duke classification revised by the ISCVID in 2023 and the Duke and Li classification. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
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.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)