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Immunoglobulin G

Clinical trials of Immunoglobulin G are studying its use in serious infections and blood cancer-related infection risk. These studies look at whether treatment can improve survival and reduce organ failure in adults with peritonitis, septic shock, or acute myeloid leukemia. The trials mainly test safety and effectiveness in hospital patients.

Table of Contents

Clinical trials overview

These studies are testing Immunoglobulin G-related treatment in people with very serious infection-related conditions and in patients with acute myeloid leukemia who are at high risk of infection.[1][2][3] All three trials are interventional studies, which means the researchers give a treatment and then measure the results.[1][2][3]

The listed trials are all authorised and are in Phase 2 or Phase 3.[1][2][3] Phase 2 trials usually look for early signs that a treatment may help, while Phase 3 trials test the treatment in a larger group to see if it works better than standard care.[1][2][3]

Peritonitis and sepsis study

NCT03334006 is a Phase 2 study in 200 patients with secondary or quaternary peritonitis and sepsis.[1] The trial is called a prospective, randomized study of personalized medicine after infectious source control in peritonitis patients.[1]

Source control means the medical or surgical step used to remove the cause of infection, such as cleaning an infected area.[1] This trial measures the change in multiple organ failure (MOF) score from the start of treatment to day 7 after source control.[1] The MOF score looks at the lungs, heart, kidneys, liver, and blood, so it shows whether organ function is improving or getting worse.[1]

Acute myeloid leukemia study

Trial 2024-518940-19-02 is a Phase 2 study in 120 patients with Acute Myeloid Leukemia (AML).[2] The brief summary says the study is looking at whether early addition of Pentaglobin to the best available antimicrobial therapy can reduce mortality and improve survival in neutropenic febrile patients with acute leukemia or after allogeneic hematopoietic stem cell transplantation (HSCT) who are colonized by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA).[2]

Neutropenic means the patient has a low number of neutrophils, which are white blood cells that help fight infection.[2] The study plans two co-primary endpoints: a 50% reduction in 30-day mortality for patients who develop a pre-engraftment bloodstream infection caused by CRE or PA, and a 20% increase in overall survival at 4 months from the start of intensive treatment compared with historical controls.[2]

Septic shock study

Trial 2024-518096-57-00 is a Phase 3, multicenter, randomized, single-blinded, two-arm, adaptive study in 356 patients with septic shock.[3] The study tests adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers versus a standard dose.[3]

The primary objective is to see whether the personalized dose is better than the flat dose at reducing all-cause mortality at day 28.[3] All-cause mortality means death from any cause during the study period.[3] This trial is focused on whether a tailored dosing approach can improve short-term survival in very sick patients with septic shock.[3]

Main endpoints and what they mean

The trials measure outcomes that show whether patients live longer or recover better after treatment.[1][2][3] In the peritonitis study, the main endpoint is the change in MOF score by day 7 after source control.[1] In the leukemia study, the endpoints are 30-day mortality and overall survival at 4 months.[2] In the septic shock study, the endpoint is all-cause mortality at day 28.[3]

These endpoints are important because they show both early and later treatment benefit.[1][2][3] They also help researchers compare the study treatment with usual care or historical controls.[2][3]

Who the studies are for

These trials are not for healthy volunteers; they focus on patients with serious illness.[1][2][3] The target groups include adults with peritonitis and sepsis, patients with septic shock, and patients with acute myeloid leukemia or after allogeneic stem cell transplantation who are at risk of difficult-to-treat infections.[1][2][3]

Because the studies are hospital-based and involve severe disease, the main focus is on safety signals, survival, and recovery from organ stress.[1][3]

Trial ID Phase Condition studied Status Enrollment
NCT03334006 Phase 2 Secondary or quaternary peritonitis, sepsis Authorised 200
2024-518940-19-02 Phase 2 Acute Myeloid Leukemia (AML) Authorised 120
2024-518096-57-00 Phase 3 Septic shock Authorised 356

FAQ

  • What conditions are being studied in Immunoglobulin G trials? The trials are studying secondary or quaternary peritonitis, septic shock, and acute myeloid leukemia. Some studies also focus on patients with bloodstream infection risk during intensive leukemia treatment or after allogeneic stem cell transplantation.
  • What is the main goal of these trials? The main goal is to see whether Immunoglobulin G-related treatment can improve outcomes such as survival and reduce multiple organ failure. The studies also measure whether the treatment lowers mortality in very sick patients.
  • What phases are the trials in? All listed trials are in Phase 2 or Phase 3. Phase 2 studies usually look at early effectiveness and safety, while Phase 3 studies test whether the treatment works better than standard care in a larger group.
  • Who may take part in these studies? The studies include adults with severe infection-related conditions such as peritonitis or septic shock, and patients with acute myeloid leukemia or after allogeneic stem cell transplant who are at risk of infection. Each trial has its own rules for who can join.
  • What outcomes are being measured? The trials measure outcomes such as multiple organ failure score, 28-day mortality, 30-day mortality, and overall survival at 4 months. These endpoints show whether treatment helps patients recover or survive longer.

Ongoing Clinical Trials on Immunoglobulin G

  • Study on the Effectiveness and Safety of IgM-Enriched Immunoglobulin Therapy for Patients with Septic Shock

    Recruiting

    1 1 1 1
    Investigated drugs:
    Italy

  • Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on Pentaglobin for Treating Fever in Acute Leukemia or Stem Cell Transplant Patients with Resistant Bacteria

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Phase 2: A trial stage that looks at early signs of benefit and safety in a smaller group of patients.
  • Phase 3: A larger trial stage that checks whether a treatment works better than usual care.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Randomized: Patients are assigned by chance to different treatment groups.
  • Single-blinded: In this type of study, one side of the study does not know which treatment is being given.
  • Septic shock: A life-threatening condition caused by infection, with very low blood pressure and organ problems.
  • Peritonitis: Inflammation or infection inside the belly area.
  • Multiple organ failure score: A score that shows how well several organs are working, such as the lungs, heart, kidneys, liver, and blood.
  • Overall Survival (OS): The length of time patients stay alive after the start of treatment.
  • Mortality: Death rate in a study group over a set time period.

References

  1. https://clinicaltrials.eu/trial/study-on-the-effects-of-immunoglobulin-a-g-and-m-in-patients-with-peritonitis-and-sepsis-after-infection-control/
  2. https://clinicaltrials.gov/study/2024-518940-19-02
  3. https://clinicaltrials.gov/study/2024-518096-57-00