ElderlyIRON-SAGENCT07739524
Iron Status Assessment in Geriatric Elderly
An observational study of Elderly and Acute Inflammatory Response, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly, Acute Inflammatory Response, Iron Deficiency
- What is being tested?
- Analysis of biological parameters
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2026to 29 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Eligible patients will be recruited from among elderly adults hospitalized for acute condition associated with a biologically documented inflammatory syndrome and for whom laboratory follow-up can be performed during and after the acute inflammatory episode.
Who may be able to join
- Age ≥ 75 years.
- Hospitalization with CRP > 50 mg/L at admission.
- Non-opposition expressed by patient or legally authorized representative
Who cannot join
- Advanced chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m²) or chronic dialysis.
- Severe hepatic impairment (Child-Pugh score B or C).
- Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).
- Hemoglobin < 9g/L
- Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.
- Blood transfusion within 3 months prior to enrollment
Show all 11Show fewer
- Ongoing treatment with erythropoiesis-stimulating agents.
- Ongoing cytotoxic chemotherapy.
- Active bleeding at the time of enrollment.
- Very limited life expectancy or inability to ensure follow-up (end-of-life care).
- Participation in another investigational medicinal product study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Orléans
Orléans, Loiret, 45067
About this study
Official title: Predicting Iron Deficiency and Related Iron Parameters Outside Inflammation in Hospitalized Elderly Patients: A Prospective Study
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
Read more
The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein [CRP] > 50 mg/L).
In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled.
Research-specific laboratory analyses will be performed on blood samples collected at 4 times:
- the day after admission;
- when CRP < 20 mg/L (pilot phase only);
- when CRP < 10 mg/L;
- five days after a CRP < 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.
Read the detailed description
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases:
- Pilot phase: A prospective, observational, single-center study enrolling up to 200 patients or conducted over a maximum recruitment period of one year, whichever occurs first.
- Main phase: A prospective, observational, multicenter study with the consecutive enrollment of 1,523 patients, including patients enrolled during the pilot phase.
The primary objective of the pilot phase is to estimate the proportion of patients with iron deficiency, defined as a transferrin saturation (TSAT) < 20%, in order to confirm the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency in the absence of inflammation.
The primary objective of the main phase is to develop and validate a predictive model for iron deficiency, defined according to the TSAT threshold in a non-inflammatory setting, with non-inflammation defined as a C-reactive protein (CRP) level < 10 mg/L (or < 20 mg/L depending on results of the pilot phase). The model will be based on measurements obtained during an acute inflammatory state in order to predict iron deficiency.
Eligible participants will be patients aged over 75 years who are hospitalized and present an acute inflammatory episode (CRP > 50 mg/L).
In addition to the routine examinations performed during hospitalization, supplementary analyses will be conducted. After admission (Day -1), patients will receive standard care from the medical team. On the day of admission (Day -1) or the following day (Day 0), patients, their trusted representatives, or relatives will be informed about the study. If the patient fulfils the eligibility criteria, he will be enrolled in the study.
Research-specific analyses will be performed on the following blood samples:
- Day 0 : blood tests (pilot phase and main study): reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin.
- When C-reactive protein (CRP) is < 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
- When CRP is < 10 mg/L (pilot phase and main study): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
- Five days after a CRP value < 10 mg/L (pilot phase and main study, optional): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
These additional analyses will be performed using routine blood samples collected during standard clinical monitoring and will not require any additional blood samples. They constitute the main research-specific intervention beyond standard clinical practice.
The objective is to develop a simple and validated tool to estimate transferrin saturation (TSAT), and potentially ferritin levels, in the absence of inflammation using data obtained during the acute inflammatory phase. This tool could help shorten hospital stays, optimize iron therapy prescribing, and improve the management of hospitalized elderly patients.
- Conditions
- Elderly, Acute Inflammatory Response, Iron Deficiency
- Being tested
- Analysis of biological parameters
- Keywords
- Transferrin Saturation, Iron Parameters, Inflammation, Elderly, Predictive model
- Medical subject headings
- Iron Deficiencies, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of biological parametersDiagnostic test
Research-specific analyses will be performed on the following blood samples:
- Day 0 : reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin.
- CRP < 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), total bilirubin, albumin, and creatine phosphokinase (CPK).
- CRP < 10 mg/L: reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, , AST, ALT, AP, total bilirubin, albumin, and CPK.
- 5 days after CRP < 10 mg/L: same as CRP < 10 mg/L
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with acute inflammation | Hospitalized patients aged >75 years admitted to hospital with an acute inflammatory episode (CRP > 50 mg/L). Receives: Diagnostic Test: Analysis of biological parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)
To estimate the proportion of patients with iron deficiency, defined as transferrin saturation (TSAT) < 20%, in order to validate the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency under non-inflammatory conditions
Measured: From enrollment to the end of study at 4 weeks maximum
To develop a predictive model for iron deficiency, defined by TSAT under non-inflammatory conditions (defined as CRP<10 mg/L or <20 mg/L, depending on results of pilot phase), using measurements obtained during acute inflammatory episode (main phase)
Transferrin saturation (TSAT) will be measured at baseline and when CRP < 10 mg/L (or < 20 mg/L, depending on results of the pilot phase). Iron deficiency will be defined as a TSAT < 20%. The predictive performance of the model for estimating TSAT under non-inflammatory conditions and the agreement between predicted and observed TSAT values under non-inflammatory conditions will be assessed.
Measured: From enrollment to the end of study at 4 weeks maximum
Secondary outcomes (5)
Proportion of patients with CRP < 20 mg/L and proportion of patients with CRP < 10 mg/L in the study population (pilot phase)
To estimate the proportion of patients with CRP < 20 mg/L and the proportion of patients with CRP < 10 mg/L, in order to refine the study population for the development of the predictive model of iron deficiency under non-inflammatory conditions.
Measured: From enrollment to the end of study at 4 weeks maximum
Among the clinically relevant variables, and within subgroups of patients with CRP < 20 mg/L and < 10 mg/L (pilot phase), to examine a/the collinearity structure among potential predictors ; b/the distribution of categorical variables
For collinearity: Associations between candidate predictors will first be assessed through bivariate analyses (Spearman's or Pearson's correlation coefficient for two continuous variables, Cramér's V for two categorical variables, and point-biserial correlation for a continuous/binary variable pair), using a predefined alert threshold of |r| or V > 0.7. A variance inflation factor (VIF) will then be calculated for each predictor retained after this initial step; variables with a VIF > 5 will be excluded.
For rare categories: Frequency distributions will be examined for each categorical variable. A category will be considered too rare if it represents less than 5% of the subgroup sample size.
Measured: From enrollment to the end of study at 4 weeks maximum
To assess the correlation between transferrin saturation measured during an inflammatory state and transferrin saturation measured under non-inflammatory conditions.
Correlation between transferrin saturation measured during inflammation (baseline sample) and transferrin saturation measured once C-reactive protein (CRP) levels have decreased to < 10 mg/L.
Measured: From enrollment to the end of study at 4 weeks maximum
To develop and validate a predictive model for iron deficiency, defined by ferritin levels under non-inflammatory conditions, with non-inflammation defined as CRP < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase).
Ferritin will be assessed at baseline and when CRP is < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase). Iron deficiency will be defined by a ferritin level < 100 µg/L. The predictive performance of the model for estimating ferritin under non-inflammatory conditions and the agreement between predicted and observed ferritin values under non-inflammatory conditions will be assessed.
Measured: From enrollment to the end of study at 4 weeks maximum
To assess the evolution of iron status parameters when CRP < 10mg/l and 5 days post CRP < 10mg/l.
Iron status parameters assessed when CRP < 10mg/l and 5 days post CRP < 10mg/l.
Measured: From enrollment to the end of study at 4 weeks maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start4 Aug 2026
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739524
- Sponsor's protocol ID
- CHUO-2025-18
- Acronym
- IRON-SAGE
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butler CC, Gillespie D, White P, Bates J, Lowe R, Thomas-Jones E, Wootton M, Hood K, Phillips R, Melbye H, Llor C, Cals JWL, Naik G, Kirby N, Gal M, Riga E, Francis NA. C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations. N Engl J Med. 2019 Jul 11;381(2):111-120. doi: 10.1056/NEJMoa1803185.
PubMed 31291514Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.
PubMed 23807094Carmona C, Bewick T, Macduff N, Thomas A; Guideline Committee. Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management-summary of NICE guidance. BMJ. 2024 Mar 11;384:q339. doi: 10.1136/bmj.q339. No abstract available.
PubMed 38467421Cichon B, Ritz C, Fabiansen C, Christensen VB, Filteau S, Friis H, Kaestel P. Assessment of Regression Models for Adjustment of Iron Status Biomarkers for Inflammation in Children with Moderate Acute Malnutrition in Burkina Faso. J Nutr. 2017 Jan;147(1):125-132. doi: 10.3945/jn.116.240028. Epub 2016 Nov 23.
PubMed 27881597Namaste SM, Rohner F, Huang J, Bhushan NL, Flores-Ayala R, Kupka R, Mei Z, Rawat R, Williams AM, Raiten DJ, Northrop-Clewes CA, Suchdev PS. Adjusting ferritin concentrations for inflammation: Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project. Am J Clin Nutr. 2017 Jul;106(Suppl 1):359S-371S. doi: 10.3945/ajcn.116.141762. Epub 2017 Jun 14.
PubMed 28615259McSorley ST, Tham A, Jones I, Talwar D, McMillan DC. Regression Correction Equation to Adjust Serum Iron and Ferritin Concentrations Based on C-Reactive Protein and Albumin in Patients Receiving Primary and Secondary Care. J Nutr. 2019 May 1;149(5):877-883. doi: 10.1093/jn/nxz008.
PubMed 31050746McSorley ST, Jones I, McMillan DC, Talwar D. Quantitative data on the magnitude of the systemic inflammatory response and its relationship with serum measures of iron status. Transl Res. 2016 Oct;176:119-26. doi: 10.1016/j.trsl.2016.05.004. Epub 2016 Jun 6.
PubMed 27337525
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Iron Deficiency and Related Iron Parameters Outside Inflammation in Hospitalized Elderly Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT07739524
- Acronym / sponsor ID
- IRON-SAGE / CHUO-2025-18
- Conditions
- Elderly, Acute Inflammatory Response, Iron Deficiency
- Keywords
- Transferrin Saturation, Iron Parameters, Inflammation, Elderly, Predictive model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein [CRP] > 50 mg/L).
In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled.
Research-specific laboratory analyses will be performed on blood samples collected at 4 times:
- the day after admission;
- when CRP < 20 mg/L (pilot phase only);
- when CRP < 10 mg/L;
- five days after a CRP < 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.
Detailed description
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases:
- Pilot phase: A prospective, observational, single-center study enrolling up to 200 patients or conducted over a maximum recruitment period of one year, whichever occurs first.
- Main phase: A prospective, observational, multicenter study with the consecutive enrollment of 1,523 patients, including patients enrolled during the pilot phase.
The primary objective of the pilot phase is to estimate the proportion of patients with iron deficiency, defined as a transferrin saturation (TSAT) < 20%, in order to confirm the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency in the absence of inflammation.
The primary objective of the main phase is to develop and validate a predictive model for iron deficiency, defined according to the TSAT threshold in a non-inflammatory setting, with non-inflammation defined as a C-reactive protein (CRP) level < 10 mg/L (or < 20 mg/L depending on results of the pilot phase). The model will be based on measurements obtained during an acute inflammatory state in order to predict iron deficiency.
Eligible participants will be patients aged over 75 years who are hospitalized and present an acute inflammatory episode (CRP > 50 mg/L).
In addition to the routine examinations performed during hospitalization, supplementary analyses will be conducted. After admission (Day -1), patients will receive standard care from the medical team. On the day of admission (Day -1) or the following day (Day 0), patients, their trusted representatives, or relatives will be informed about the study. If the patient fulfils the eligibility criteria, he will be enrolled in the study.
Research-specific analyses will be performed on the following blood samples:
- Day 0 : blood tests (pilot phase and main study): reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin.
- When C-reactive protein (CRP) is < 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
- When CRP is < 10 mg/L (pilot phase and main study): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
- Five days after a CRP value < 10 mg/L (pilot phase and main study, optional): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (%), ferritin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, albumin, and creatine phosphokinase.
These additional analyses will be performed using routine blood samples collected during standard clinical monitoring and will not require any additional blood samples. They constitute the main research-specific intervention beyond standard clinical practice.
The objective is to develop a simple and validated tool to estimate transferrin saturation (TSAT), and potentially ferritin levels, in the absence of inflammation using data obtained during the acute inflammatory phase. This tool could help shorten hospital stays, optimize iron therapy prescribing, and improve the management of hospitalized elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with acute inflammation | – | Diagnostic Test: Analysis of biological parametersHospitalized patients aged >75 years admitted to hospital with an acute inflammatory episode (CRP > 50 mg/L). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Eligible patients will be recruited from among elderly adults hospitalized for acute condition associated with a biologically documented inflammatory syndrome and for whom laboratory follow-up can be performed during and after the acute inflammatory episode.
Key inclusion criteria (3 listed)
- Age ≥ 75 years.
- Hospitalization with CRP > 50 mg/L at admission.
- Non-opposition expressed by patient or legally authorized representative
Key exclusion criteria (11 listed)
- Advanced chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m²) or chronic dialysis.
- Severe hepatic impairment (Child-Pugh score B or C).
- Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).
- Hemoglobin < 9g/L
- Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of biological parametersResearch-specific analyses will be performed on the following blood samples: * Day 0 : reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin. * CRP < 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), total bilirubin, albumin, and creatine phosphokinase (CPK). * CRP < 10 mg/L: reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, , AST, ALT, AP, total bilirubin, albumin, and CPK. * 5 days after CRP < 10 mg/L: same as CRP < 10 mg/L | Diagnostic test | Elderly patients with acute inflammation |
Primary outcome
Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)
Time frame: From enrollment to the end of study at 4 weeks maximum
To estimate the proportion of patients with iron deficiency, defined as transferrin saturation (TSAT) < 20%, in order to validate the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency under non-inflammatory conditions
To develop a predictive model for iron deficiency, defined by TSAT under non-inflammatory conditions (defined as CRP<10 mg/L or <20 mg/L, depending on results of pilot phase), using measurements obtained during acute inflammatory episode (main phase)
Time frame: From enrollment to the end of study at 4 weeks maximum
Transferrin saturation (TSAT) will be measured at baseline and when CRP < 10 mg/L (or < 20 mg/L, depending on results of the pilot phase). Iron deficiency will be defined as a TSAT < 20%. The predictive performance of the model for estimating TSAT under non-inflammatory conditions and the agreement between predicted and observed TSAT values under non-inflammatory conditions will be assessed.
5 secondary outcomes
Proportion of patients with CRP < 20 mg/L and proportion of patients with CRP < 10 mg/L in the study population (pilot phase)
Time frame: From enrollment to the end of study at 4 weeks maximum
Among the clinically relevant variables, and within subgroups of patients with CRP < 20 mg/L and < 10 mg/L (pilot phase), to examine a/the collinearity structure among potential predictors ; b/the distribution of categorical variables
Time frame: From enrollment to the end of study at 4 weeks maximum
To assess the correlation between transferrin saturation measured during an inflammatory state and transferrin saturation measured under non-inflammatory conditions.
Time frame: From enrollment to the end of study at 4 weeks maximum
To develop and validate a predictive model for iron deficiency, defined by ferritin levels under non-inflammatory conditions, with non-inflammation defined as CRP < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase).
Time frame: From enrollment to the end of study at 4 weeks maximum
To assess the evolution of iron status parameters when CRP < 10mg/l and 5 days post CRP < 10mg/l.
Time frame: From enrollment to the end of study at 4 weeks maximum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 31291514Butler CC, Gillespie D, White P, Bates J, Lowe R, Thomas-Jones E, Wootton M, Hood K, Phillips R, Melbye H, Llor C, Cals JWL, Naik G, Kirby N, Gal M, Riga E, Francis NA. C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations. N Engl J Med. 2019 Jul 11;381(2):111-120. doi: 10.1056/NEJMoa1803185.
- Background: PubMed 23807094Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.
- Background: PubMed 38467421Carmona C, Bewick T, Macduff N, Thomas A; Guideline Committee. Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management-summary of NICE guidance. BMJ. 2024 Mar 11;384:q339. doi: 10.1136/bmj.q339. No abstract available.
- Background: PubMed 27881597Cichon B, Ritz C, Fabiansen C, Christensen VB, Filteau S, Friis H, Kaestel P. Assessment of Regression Models for Adjustment of Iron Status Biomarkers for Inflammation in Children with Moderate Acute Malnutrition in Burkina Faso. J Nutr. 2017 Jan;147(1):125-132. doi: 10.3945/jn.116.240028. Epub 2016 Nov 23.
- Background: PubMed 28615259Namaste SM, Rohner F, Huang J, Bhushan NL, Flores-Ayala R, Kupka R, Mei Z, Rawat R, Williams AM, Raiten DJ, Northrop-Clewes CA, Suchdev PS. Adjusting ferritin concentrations for inflammation: Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project. Am J Clin Nutr. 2017 Jul;106(Suppl 1):359S-371S. doi: 10.3945/ajcn.116.141762. Epub 2017 Jun 14.
- Background: PubMed 31050746McSorley ST, Tham A, Jones I, Talwar D, McMillan DC. Regression Correction Equation to Adjust Serum Iron and Ferritin Concentrations Based on C-Reactive Protein and Albumin in Patients Receiving Primary and Secondary Care. J Nutr. 2019 May 1;149(5):877-883. doi: 10.1093/jn/nxz008.
- Background: PubMed 27337525McSorley ST, Jones I, McMillan DC, Talwar D. Quantitative data on the magnitude of the systemic inflammatory response and its relationship with serum measures of iron status. Transl Res. 2016 Oct;176:119-26. doi: 10.1016/j.trsl.2016.05.004. Epub 2016 Jun 6.
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Postoperative Delirium (POD), Intracranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Acute Inflammatory Response, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moez JALLOULI, Principal Investigator (02 38 61 30 15 ext. +33, moez.jallouli@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase) (time frame: From enrollment to the end of study at 4 weeks maximum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07739524, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.