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New treatment option for Infective Endocarditis (IE)
Official title Anemia Therapy in Patients With Infective Endocarditis
ClinicalTrials.gov ID: NCT07523646
What this study is testing
What is Adjunctive anemia therapy?
Adjunctive anemia therapy is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for infective endocarditis (ie).
Also referred to as Iron and EPO therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Infective endocarditis (IE) is a bacterial infection of the heart valves, inserted material or surrounding struc-tures and is associated with a high morbidity and mortality. In patients with IE, anemia is considered to result from the underlying infection, prolonged sustained inflammatory response due to the often slow natural course of the disease, and coexisting comorbidities.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- Confirmed bacterial endocarditis.
- Hb ≤6.0 mmol/l
- Stabilization criteria:
- Stable condition (patients with satisfactory clinical response to initial treatment)
You likely can't join if
- Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \>20 mg prednisolone...
- Inability to provide informed consent for participation
- Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months)
- Allergy / intolerance to EPO or iron therapy
- Inability to complete a 6MWT
- Hematological conditions, that contradicts use of IV iron therapy
See the full eligibility criteria
- 18 years or older
- Confirmed bacterial endocarditis.
- Hb ≤6.0 mmol/l
- Stabilization criteria:
- Stable condition (patients with satisfactory clinical response to initial treatment)
- At least 10 days with IV administered antibiotic treatment and at least 7 days after surgery in cases of valve surgery.
- Transesophageal echocardiography (TEE) performed prior to randomization with no signs of abscess formation or valve abnormalities, which would require surgery.
- No fever for at least 48 hours prior to enrollment.No positive blood cultures within last 4 days prior to randomization.
- CRP \ 25% reduction from peak value.
- Leucocytes \ 25% reduction from peak value.
- Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \>20 mg prednisolone equivalent/day)
- Inability to provide informed consent for participation
- Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months)
- Allergy / intolerance to EPO or iron therapy
- Inability to complete a 6MWT
- Hematological conditions, that contradicts use of IV iron therapy
- Death prior to clinical stabilization
- Failure to fulfill criteria of clinical stabilization
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.