An interventional study of ⁵⁷Fe-labelled ferrous sulphate and ⁵⁸Fe-citrate in Inflammation, Iron Absorption and Community-Acquired Pneumonia (CAP), sponsored by University of Zurich. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Zurich · Not applicable, Interventional, and Basic science
Among 14 studies in Community-Acquired Pneumonia with a site in Switzerland — 4 open to participants now, 4 under way, 1 of them phase 3. Community-Acquired Pneumonia · Switzerland.
Among the 14 studies in Community-Acquired Pneumonia with a site in Switzerland, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is one of 4 with no phase, and was the 14th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →4 of the 14 studies in Community-Acquired Pneumonia with a site in Switzerland are open now. Recruiting first, the newest first:
Christoph Berger · Sites in Switzerland
Ages 3–17
University Hospital, Basel, Switzerland · Sites in Switzerland
Ages 18+ · Healthy volunteers
UMC Utrecht · Sites in Switzerland, United States, Australia and 26 more countries
Ages 28 days+
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Median enrollment 516 across the 10 interventional studies, 111 across the 4 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 14 have an industry lead sponsor. The 10 most frequent:
University of Zurich is the lead sponsor of 1,050 studies on the registry; 134 are open to participants now.
University of Zurich has 2 studies filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Community-Acquired Pneumonia with a site in Switzerland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn how acute inflammation affects the body's ability to absorb iron in adults who are hospitalized with community-acquired pneumonia.
The main questions it aims to answer are:
Participants will:
Iron deficiency is common in patients with acute inflammatory diseases and contributes to impaired erythropoiesis and delayed recovery. During acute inflammation, increased hepcidin concentrations reduce intestinal iron absorption and alter systemic iron homeostasis by limiting iron export from enterocytes and macrophages. Although these mechanisms are well established, quantitative data on fractional iron absorption during acute inflammation and its recovery after resolution of the inflammatory response remain limited.
This prospective, single-centre, open-label, mechanistic interventional study is designed to quantify fractional iron absorption during acute inflammation and compare it with fractional iron absorption after recovery in the same participant. Participants hospitalized with community-acquired pneumonia and marked systemic inflammation (C-reactive protein >=100 mg/L) undergo the identical dual stable-isotope procedure twice: once during the acute phase, within 72 hours of hospitalization (Visit 1), and once during convalescence, 3 to 8 weeks after hospital discharge and only after C-reactive protein has fallen to \<=10 mg/L (Visit 3).
At each of the two dosing visits, following a fast of at least 4 hours, participants receive a single oral dose of 10 mg elemental iron as stable isotope-labelled ⁵⁷Fe-ferrous sulphate, taken under supervision with 200 mL of water and a standardised test meal of white bread, butter and honey. Fasting continues for 4 hours after the oral dose. One hour after the oral dose, a reference dose of 100 µg total iron as stable isotope-labelled ⁵⁸Fe-citrate, diluted in 100 mL of 0.9% sodium chloride, is infused over 50 minutes by infusion pump through a peripheral venous catheter, with monitoring during and after the infusion. Both isotopes are non-radioactive and are given at tracer doses; the oral dose is approximately one tenth of a usual therapeutic daily iron dose and is not expected to alter iron status.
Fractional iron absorption is determined 14 to 21 days after each administration (Visits 2 and 4) from the erythrocyte incorporation of the oral ⁵⁷Fe tracer relative to the intravenous ⁵⁸Fe reference tracer, measured by inductively coupled plasma mass spectrometry. Baseline erythrocyte isotope ratios are measured before each dosing visit to correct for pre-existing isotopic enrichment.
Serial blood samples will be collected to assess iron metabolism and inflammatory activity, including serum iron, ferritin, transferrin saturation, total iron-binding capacity, soluble transferrin receptor, erythroferrone, hepcidin, C-reactive protein, interleukin-6, haemoglobin, haematocrit, reticulocyte measures and other laboratory parameters specified in the protocol. Measurements obtained during acute inflammation will be compared with those obtained during convalescence to evaluate the effects of resolution of inflammation on intestinal iron absorption and systemic iron metabolism.
In supporting exploratory analyses, fractional iron absorption (% of the oral dose absorbed) will be correlated separately with serum hepcidin (ng/mL), C-reactive protein (mg/L) and interleukin-6 (pg/mL). Each absorption value at Visits 2 and 4 will be paired with the biomarker concentrations measured at the same visit. Serum hepcidin will be measured by competitive enzyme-linked immunosorbent assay, with additional mass spectrometry if applicable. The University Hospital Zurich central laboratory will measure C-reactive protein and interleukin-6 using routine clinical assays. Each correlation will be reported as a unitless coefficient with a 95% confidence interval, accounting for repeated measurements within participants.
A total of 48 participants will be enrolled with the aim of obtaining 38 evaluable paired datasets. Fractional iron absorption will be analysed on the log10 scale, and the primary within-participant comparison will use a paired two-sided t-test at alpha 0.05, with results reported as geometric mean ratios and 95% confidence intervals. The findings will improve understanding of the relationship between acute inflammation, hepcidin, and iron absorption and provide mechanistic evidence to inform future studies and therapeutic strategies for the management of iron deficiency in patients with acute inflammatory diseases.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
This study's planned enrollment of 48 is below the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →University of Zurich is the lead sponsor of 1,050 studies on the registry; 134 are open to participants now.
Compared within Community-Acquired Pneumonia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant undergoes the identical dual stable-isotope procedure twice: once during the acute inflammatory phase (Visit 1) and once during convalescence (Visit 3). At each dosing visit an oral dose of ⁵⁷Fe-labelled ferrous sulphate is followed one hour later by a small intravenous ⁵⁸Fe-citrate reference dose. Fractional iron absorption is determined 14-21 days after each administration from erythrocyte incorporation of both stable isotopes, giving a within-participant comparison of absorption during acute inflammation and after recovery.
Other: ⁵⁷Fe-labelled ferrous sulphate · Other: ⁵⁸Fe-citrate
Single oral dose of 10 mg elemental iron as stable isotope-labelled ⁵⁷Fe-ferrous sulfate, administered under supervision with 200 mL water and a standardised test meal (white bread, butter, honey) after a fast of at least 4 hours; fasting continues for 4 hours after dosing. Administered twice per participant: once during the acute inflammatory phase (Visit 1, within 72 hours of hospitalization, CRP \>=100 mg/L) and once during convalescence (Visit 3, 3-8 weeks after hospital discharge, CRP \<=10 mg/L). The oral tracer serves as the test dose for quantification of fractional intestinal iron absorption.
Single intravenous reference dose of 100 µg total iron as stable isotope-labelled ⁵⁸Fe-citrate, diluted in 100 mL 0.9% sodium chloride and infused over 50 minutes by infusion pump through a peripheral venous catheter, starting 1 hour after the oral ⁵⁷Fe dose, with monitoring during and after the infusion. Administered twice per participant, at Visit 1 (acute inflammatory phase) and Visit 3 (convalescent phase). Because the intravenous tracer bypasses the intestine, it serves as the reference tracer for calculating fractional iron absorption from erythrocyte incorporation of the oral relative to the intravenous isotope.
Within-Participant Change in Fractional Iron Absorption Between Acute Inflammation and Convalescence
Fractional iron absorption is the percentage of the oral iron dose absorbed. It is calculated as 100 times the fraction of the oral ⁵⁷Fe dose incorporated into erythrocytes divided by the fraction of the intravenous ⁵⁸Fe reference dose incorporated into erythrocytes. Erythrocyte isotope ratios are measured by inductively coupled plasma mass spectrometry. The paired comparison uses log-transformed absorption values and is reported as the convalescent-to-acute geometric mean ratio with a 95% confidence interval.
Time frame: Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
Within-Participant Change in Serum Hepcidin Concentration Between Acute Inflammation and Convalescence
Serum hepcidin concentration (ng/mL) is measured by competitive enzyme-linked immunosorbent assay, with additional mass spectrometry if applicable. Acute-phase and convalescent concentrations are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Blood Hemoglobin Concentration Between Acute Inflammation and Convalescence
Blood hemoglobin concentration (g/L) is measured by routine laboratory hematology. The outcome is the concentration at Visit 3 minus the concentration at Visit 1 (g/L). Values at all four visits are also summarized descriptively.
Time frame: Change from Visit 1 (within 72 hours of hospital admission) to Visit 3 (scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L). Additional descriptive measurements are taken 14-21 days after each of these visits.
Erythrocyte Incorporation of Intravenously Administered ⁵⁸Fe
The percentage of the intravenous ⁵⁸Fe dose incorporated into circulating erythrocytes is determined from blood isotope measurements by inductively coupled plasma mass spectrometry. The percentage after acute-phase dosing is compared with the percentage after convalescent-phase dosing within the same participant.
Time frame: Visit 2, 14-21 days after acute-phase dosing at Visit 1, and Visit 4, 14-21 days after convalescent-phase dosing at Visit 3. Visit 3 is scheduled 3-8 weeks after hospital discharge once C-reactive protein is ≤10 mg/L.
Within-Participant Change in Hematocrit Between Acute Inflammation and Convalescence
Hematocrit is the percentage of whole blood volume occupied by erythrocytes. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Serum Ferritin Concentration Between Acute Inflammation and Convalescence
Serum ferritin concentration is measured in micrograms per liter (µg/L). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Serum Iron Concentration Between Acute Inflammation and Convalescence
Serum iron concentration is measured in micromoles per liter (µmol/L). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Transferrin Saturation Between Acute Inflammation and Convalescence
Transferrin saturation is the percentage of total iron-binding capacity occupied by iron. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Total Iron-Binding Capacity Between Acute Inflammation and Convalescence
Total iron-binding capacity is measured in micromoles of iron per liter (µmol/L). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Soluble Transferrin Receptor Concentration Between Acute Inflammation and Convalescence
Soluble transferrin receptor concentration is measured in milligrams per liter (mg/L). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Erythroferrone Concentration Between Acute Inflammation and Convalescence
Erythroferrone concentration is measured in nanograms per milliliter (ng/mL). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in C-Reactive Protein Concentration Between Acute Inflammation and Convalescence
C-reactive protein concentration is measured in milligrams per liter (mg/L) by the University Hospital Zurich central laboratory. Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Interleukin-6 Concentration Between Acute Inflammation and Convalescence
Interleukin-6 concentration is measured in picograms per milliliter (pg/mL) by the University Hospital Zurich central laboratory. Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Absolute Reticulocyte Count Between Acute Inflammation and Convalescence
The absolute reticulocyte count is measured in billions of reticulocytes per liter of whole blood (10⁹/L). Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Reticulocyte Percentage Between Acute Inflammation and Convalescence
Reticulocytes are reported as a percentage of the total red blood cell count. Acute-phase and convalescent values are compared within each participant. The change is expressed in percentage points.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Ferritin Subunit Composition Between Acute Inflammation and Convalescence
Ferritin Subunit ratio in coded blood samples using mass spectrometry. The result is expressed unitless as a ratio. Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Within-Participant Change in Ferritin Iron Loading Between Acute Inflammation and Convalescence
We will measure iron associated with ferritin in coded blood samples using mass spectrometry. The result is expressed in ng iron per ferritin-subunit. Acute-phase and convalescent values are compared within each participant.
Time frame: Visit 1, within 72 hours of hospital admission. Visit 2, 14-21 days after Visit 1. Visit 3, scheduled 3-8 weeks after discharge once C-reactive protein is ≤10 mg/L. Visit 4, 14-21 days after Visit 3.
Incidence, Severity and Relatedness of Adverse Events and Serious Adverse Events
Number of participants with at least one adverse event or serious adverse event, summarised by severity (mild, moderate, severe) and by relationship to the study intervention (definitely, probably, possibly, unlikely, not related). Events of particular interest are collected by active enquiry at every visit: venipuncture-related events (haematoma, local pain, infection), intravenous administration events (extravasation, phlebitis, infusion reaction), and gastrointestinal symptoms following the oral isotope dose. Clinically relevant abnormalities in routine laboratory parameters and vital signs are also recorded.
Time frame: From first isotope administration (Visit 1) through the final study visit (Visit 4, Day 14-21 after convalescent-phase dosing); up to approximately 20 weeks per participant. Ongoing events are followed until resolution or stabilisation.
Plan to share: Yes — The study protocol and statistical analysis plan (SAP) will be published to ensure transparency of the study design and pre-specified analyses. Along with publication of the primary study results, anonymised individual participant data underlying the published analyses will be shared. The shared dataset will include all participant-level data required to reproduce the published findings, including clinical data, laboratory measurements, stable iron isotope measurements, derived variables, analytic code, metadata, and a data dictionary. These materials will be deposited in Zenodo and assigned a persistent DOI.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Anonymised individual participant data and supporting documentation will become available at the time of publication of the primary study results, and no later than 12 months after that publication. Once deposited, the data, study protocol, statistical analysis plan, analytic code, metadata and data dictionary will remain publicly available indefinitely through Zenodo under a persistent DOI, with no end date.
Access criteria: The anonymised individual participant dataset, study protocol, statistical analysis plan, analytic code, metadata and data dictionary will be publicly available to anyone without restriction through Zenodo, via a persistent DOI. No data sharing agreement or request procedure applies. Before deposition the dataset is anonymised: direct identifiers are removed, calendar dates are replaced by intervals relative to the first study visit, free-text fields are removed or recoded, and rare or potentially distinguishing values are aggregated or top-coded, so that re-identification is not reasonably possible. Anonymisation is documented and approved by the Principal Investigator and the responsible statistician prior to release. All materials are prepared in accordance with the applicable ethical approvals, participant consent, institutional policies and Swiss data protection law.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 42 non-industry interventional studies with no phase under Community-Acquired Pneumonia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 38. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 24 months; a quarter within 14 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →