Adenovirus infection – Trials in Disease

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Ongoing Clinical Trials for Adenovirus Infection

Currently, there are 2 ongoing clinical trials investigating new treatments for adenovirus infection. These studies are taking place across multiple European countries and are testing different approaches: one focuses on using specialized immune cells to fight resistant viral infections in transplant patients, while the other examines whether a steroid medication can help reduce fever in young children with adenovirus infection.

Clinical trial locations

Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells

This trial is testing a specialized treatment for patients who have undergone stem cell transplantation and are now dealing with viral infections that don’t respond to standard antiviral medications. The treatment uses specially designed immune cells called allogeneic multivirus-specific T cells, which are trained to recognize and attack three specific viruses: cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV).

Who can participate: The study is open to adults and children older than 2 months who have received a hematopoietic stem cell transplantation. Participants must have a new or reactivated infection with CMV, EBV, or adenovirus that has not improved after two weeks of standard antiviral treatment. The infection must be confirmed by a blood test showing that the virus levels have not decreased significantly. The original stem cell donor must be available and have an immune response to the virus. Written consent from the patient or their legal representative is required.

Who cannot participate: Patients who have not undergone stem cell transplantation are excluded. Those without a new or reactivated infection with CMV, EBV, or adenovirus, or whose infections are still responding to standard treatments, cannot join. Children under 2 months of age are also excluded.

What the study involves: The main focus is to evaluate whether the T cell treatment can effectively clear viral infections in patients who haven’t responded to other treatments. The T cells are given directly into the bloodstream through an infusion. Researchers will monitor patients over several weeks to see if the virus levels decrease or disappear, and to watch for any side effects. Various health measures will be tracked, including the amount of virus in the blood and any symptoms related to the infections.

Treatment being tested: The investigational treatment is multispecific T cells, which are specially engineered immune cells designed to target and fight specific viruses. These cells work by helping the patient’s immune system better recognize and eliminate CMV, EBV, and adenovirus infections.

Study on Betamethasone for Children with Adenovirus Infection

This clinical trial is investigating whether betamethasone, a steroid medication, can help reduce fever more quickly in young children with adenovirus infection. The study compares betamethasone to a placebo, which contains no active medication, to determine if adding a single dose of betamethasone to standard fever-reducing treatments like paracetamol or ibuprofen can help more children become fever-free within 24 hours.

Who can participate: Children between 6 months and 6 years of age (weighing between 5 and 27 kg) can join if they have had a fever above 37.5°C for at least 6 hours but no more than 5 days. They must have symptoms suggesting a throat infection with adenovirus, such as sore throat, weakness, reduced appetite, nausea, vomiting, diarrhea, cough, runny nose, abdominal pain, or ear pain. At least one physical sign must be present, such as throat redness, airway inflammation, swollen lymph nodes, or skin rash. A positive rapid adenovirus test is required, and parents or legal guardians must provide signed consent.

Who cannot participate: Children without confirmed adenovirus infection cannot join. Those younger than 6 months or older than 6 years are excluded. Children who cannot take standard fever-reducing medications like paracetamol or ibuprofen, or who have other medical conditions that might interfere with the study, are also excluded.

What the study involves: The goal is to determine if betamethasone can help reduce fever more effectively than standard treatment alone. Children will be randomly assigned to receive either betamethasone or placebo in addition to their regular fever-reducing medication. Body temperature will be monitored closely to see how quickly the fever resolves. The study will also measure throat pain levels and whether hospitalization is needed.

Treatments being tested: The main investigational drug is betamethasone, which works by reducing inflammation and suppressing the immune response to help lower fever. The study also involves standard fever-reducing medications paracetamol and ibuprofen, which are commonly used to manage fever and discomfort in children.

Summary

The two ongoing clinical trials for adenovirus infection represent distinctly different approaches to treatment, targeting separate patient populations. The first trial focuses on a highly specialized group—patients who have undergone stem cell transplantation and are facing treatment-resistant viral infections. This study is conducted across multiple European countries including Belgium, France, Netherlands, Germany, and Italy, reflecting the international collaboration needed for this complex immunotherapy approach.

The second trial takes a different direction, examining a simpler intervention for young children with common adenovirus infections in Italy. This study tests whether a widely available steroid medication can improve fever management when added to standard treatments.

Both trials demonstrate the range of ongoing research into adenovirus infections, from cutting-edge cellular therapies for the most vulnerable transplant patients to practical treatment improvements for everyday pediatric infections. The geographic concentration of the multivirus T cell trial across several European countries suggests the need for larger patient pools when studying rare complications in transplant recipients.

Ongoing Clinical Trials on Adenovirus infection

  • Comparing brincidofovir and cidofovir for treating adenovirus infection in children and adults after stem cell transplantation

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain
  • Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells

    Recruiting

    3 1
    Belgium France Germany Italy The Netherlands
  • Study on Betamethasone for Children with Adenovirus Infection

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Italy