Study on Betamethasone for Children with Adenovirus Infection

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What is this study about?

This clinical trial is focused on studying the effects of a medication called betamethasone in children who have an Adenovirus infection. Adenovirus is a common virus that can cause symptoms like fever, sore throat, and other flu-like symptoms. The study will compare the effects of betamethasone to a placebo, which is a substance with no active medication, to see if betamethasone can help reduce fever in children with this infection.

The purpose of the study is to determine if a single dose of betamethasone, in addition to standard fever-reducing treatments like paracetamol or ibuprofen, can help more children become fever-free within 24 hours. Children participating in the study will receive either betamethasone or a placebo, and their body temperature will be monitored to see how quickly their fever resolves. The study will also look at other factors, such as the level of throat pain and whether hospitalization is needed.

Participants in the study will be children between the ages of 6 months and 6 years who have a confirmed Adenovirus infection and a fever. The study aims to provide valuable information on whether betamethasone can be an effective treatment option for reducing fever in children with Adenovirus infections. The trial is expected to run until June 2025, with recruitment starting in March 2024.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the study medication or a placebo. This process is called randomization and ensures that the study results are unbiased.

2 medication administration

The patient will receive a single dose of the study medication, which is an effervescent tablet containing betamethasone sodium phosphate. This medication is taken by mouth, dissolved in water, and is intended to help reduce fever associated with adenovirus infection.

The dosage of the medication is 0.5 mg and it is administered only once during the study period.

3 monitoring and follow-up

The patient’s body temperature will be monitored to assess the effectiveness of the medication. The primary goal is to determine if the patient’s fever resolves within 24 hours after receiving the medication.

Additional assessments will include measuring the level of throat pain using age-appropriate pain scales and monitoring for any need for hospitalization.

4 end of participation

The patient’s participation in the study will conclude after the final assessments are completed. The study aims to gather data on the resolution of fever and any other relevant health outcomes.

Who Can Join the Study?

Age between 6 months and 6 years (body weight between 5 and 27 kg).
Body temperature measured with an axillary (underarm) or ear thermometer greater than 37.5°C for at least 6 hours and no more than 5 days.
Symptoms that suggest a throat infection with Adenovirus. These symptoms can include:
- Pharyngodynia (sore throat)
- Asthenia (weakness)
- Hyporexia (reduced appetite)
- Nausea
- Vomiting
- Diarrhea
- Cough
- Rhinitis (runny nose)
- Abdominal pain
- Otalgia (ear pain)
At least one of the following signs:
- Pharyngeal hyperaemia (redness in the throat) with or without pharyngotonsillar exudate (pus on the tonsils)
- Upper or lower airway inflammation
- Lymphadenopathy (swollen lymph nodes)
- Skin rash
Positive result from a rapid Adenovirus test using a “Biosensor” swab.
Negative result for SBEGA (a specific bacterial test), if necessary, based on certain criteria.
Signed informed consent form by the parent(s) or legal guardian(s) for the child’s participation in the trial.

Who Cannot Join the Study?

Patients who are not infected with adenovirus cannot participate. Adenovirus is a type of virus that can cause infections in different parts of the body.
Children younger than 2 years old cannot participate.
Children older than 18 years old cannot participate.
Patients who are not experiencing a fever due to adenovirus infection cannot participate.
Patients who are not able to take standard fever-reducing medications like paracetamol or ibuprofen cannot participate. These are common medicines used to reduce fever and relieve pain.
Patients who have any other medical conditions that might interfere with the study cannot participate.
Patients who are part of a vulnerable population that requires special protection cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ajbenbi Oensvarhulj Uyyihtyxtxgde Cjpcnwbzwcxo Dhlry Svvppu E Dgpkw Sawphnt Dt Tdqrju	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	15.03.2024

Trial locations

Investigated drugs:

Betamethasone is a medication used in this clinical trial to help reduce inflammation and suppress the immune system. In this study, it is being tested to see if it can help children with adenovirus infections feel better by reducing their fever. The goal is to see if giving betamethasone can help more children become fever-free within 24 hours compared to those who do not receive it.

Paracetamol, also known as acetaminophen, is a common medication used to relieve pain and reduce fever. In this trial, it is part of the standard treatment given to children with adenovirus infections to help manage their symptoms, especially fever.

Ibuprofen is another medication used to relieve pain and reduce fever. Like paracetamol, it is part of the standard treatment in this study for children with adenovirus infections. It helps to manage symptoms by lowering fever and providing relief from discomfort.

Investigated diseases:

Adenovirus infection

Adenovirus infection – Adenovirus infection is caused by adenoviruses, which are a group of viruses that can infect the lining of the eyes, airways and lungs, intestines, urinary tract, and nervous system. The infection often begins with symptoms similar to the common cold, such as a sore throat, fever, and cough. As the infection progresses, it can lead to more severe respiratory illnesses, especially in young children and those with weakened immune systems. In some cases, adenovirus can cause conjunctivitis, also known as pink eye, and gastrointestinal symptoms like diarrhea. The virus spreads easily through close personal contact, respiratory droplets, and touching contaminated surfaces. Symptoms usually appear 2 to 14 days after exposure and can last for several days to weeks, depending on the severity of the infection.

Trial ID:

2024-518095-31-00

NCT ID:

NCT06299813

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Betamethasone for Children with Adenovirus Infection

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