Study on Reducing Antibiotic Duration for Pneumonia in Children Using Amoxicillin

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What is this study about?

This clinical trial is focused on studying a condition known as community-acquired pneumonia in children. This type of pneumonia is an infection of the lungs that children can catch outside of a hospital setting. The study is testing a treatment using a medication called amoxicillin trihydrate, which is a type of antibiotic that helps fight bacterial infections. The goal of the study is to see if a shorter course of this antibiotic is just as effective as a longer one in treating pneumonia in children.

In this study, children aged between 3 months and 59 months who have been diagnosed with community-acquired pneumonia will receive amoxicillin trihydrate. The treatment will be given in two different ways: one group will receive the antibiotic for 3 days if they respond quickly to the treatment, or for 5 days if their response is slower. The other group will receive the antibiotic for 5 days if they respond quickly, or for 7 days if their response is slower. The study aims to find out if the shorter treatment is as effective as the longer one in preventing treatment failure, which means the treatment does not work as expected.

The study will monitor the children for any signs of treatment failure, such as the need to change the antibiotic, worsening of pneumonia, or the need for hospitalization. It will also look at any side effects from the antibiotic and how well the children follow the treatment plan. The study will help determine the best duration for antibiotic treatment in children with community-acquired pneumonia, aiming to reduce unnecessary antibiotic use while ensuring effective treatment.

1 joining the study

Upon joining the study, the child must be between 3 and 59 months old and diagnosed with community-acquired alveolar pneumonia. This diagnosis is based on specific criteria, including fever, rapid breathing, and certain findings on a chest x-ray.

The child should not have been hospitalized for this condition and the episode must have started less than 7 days before joining the study.

2 initial treatment phase

The child will receive amoxicillin trihydrate as the treatment. This medication is taken orally.

The dosage is 80-100 mg per kilogram of the child’s weight per day. The duration of this treatment depends on the child’s response to the medication.

3 treatment duration based on response

If the child shows a rapid response to the treatment, the antibiotic will be administered for 3 days.

If the response is delayed, the treatment will continue for 5 days.

4 monitoring and evaluation

The primary goal is to assess the rate of treatment failure by day 7. This includes any need to change the antibiotic due to lack of improvement or worsening of the condition.

Secondary evaluations will occur by day 30, checking for any hospitalizations, complications, or relapses related to the pneumonia.

5 follow-up and final assessment

The study will monitor for any adverse effects from the antibiotic up to day 30.

Compliance with the treatment regimen will be assessed, and the total duration of antibiotic use will be recorded during visits on day 7 and day 30.

Who Can Join the Study?

The child must be between 3 months and 59 months old.
The child must have a diagnosis of community-acquired alveolar pneumonia. This means the child has pneumonia that was caught outside of a hospital. The diagnosis is based on having 3 major signs and at least 3 out of 5 minor signs:

Major signs include:
- Fever higher than 38°C (100.4°F)
- Fast breathing (polypnea)
- A specific finding on a chest X-ray called a focus of condensation
Minor signs include:
- Localized crackles (a specific sound in the lungs)
- C-Reactive Protein (CRP) level higher than 80 mg/L (a blood test that shows inflammation)
- General condition is altered (the child seems unwell)
- Cough
- Pulmonary condensation syndrome (another specific finding in the lungs)

The child’s pneumonia episode must have started less than 7 days before joining the study, and it must have started outside of a hospital.
The child must not have any reasons that would require them to be hospitalized.

Who Cannot Join the Study?

Children who are not between 3 and 59 months old cannot participate.
Children with severe forms of pneumonia cannot participate.
Children who have allergies to the antibiotic amoxicillin cannot participate. Amoxicillin is a type of medicine used to treat infections.
Children who have other serious health conditions that might affect the study cannot participate.
Children who are currently participating in another clinical trial cannot participate.
Children who have taken antibiotics recently for another illness cannot participate.
Children who have a history of not responding well to antibiotics cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hopital Des Enfants	Toulouse	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier De Perpignan	Perpignan	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cqljbc Heyfdobflin Eu Uxcpstnilyjqw Da Lctbunt	Limoges	France
Aksenkfumc Phtnelyp Hsokwsnj Dn Mrldptema	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2024

Trial locations

Investigated drugs:

Amoxicillin Trihydrate

Amoxicillin: This medication is an antibiotic used to treat infections caused by bacteria. In this trial, it is being used to treat community-acquired alveolar pneumonia in children. The study is testing whether a shorter course of amoxicillin is as effective as a longer course in treating this type of pneumonia.

Investigated diseases:

Pneumonia

Community-acquired alveolar pneumonia in children – This is a type of lung infection that occurs in children who have not recently been in a hospital or healthcare facility. It affects the alveoli, which are tiny air sacs in the lungs where oxygen and carbon dioxide are exchanged. The disease typically begins with symptoms such as fever, cough, and difficulty breathing. As it progresses, children may experience increased respiratory distress and fatigue. The infection can lead to inflammation and fluid accumulation in the lungs, making it harder for the child to breathe. The condition is usually caused by bacteria, but viruses can also be responsible.

Trial ID:

2024-512236-30-00

Protocol code:

RECHMPL22_0399

NCT ID:

NCT06291012

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Antibiotic Duration for Pneumonia in Children Using Amoxicillin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?