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Study on the Effect of Amoxicillin in Preschool Children with Pneumonia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on children with pneumonia, a type of lung infection that affects the lower respiratory tract. The treatment being tested is amoxicillin, a commonly used antibiotic, compared to a placebo. The purpose of the study is to determine the effect of amoxicillin in preschool children with pneumonia.

Participants in the study will receive either amoxicillin or a placebo. The treatment will be administered as an oral suspension, which is a liquid form taken by mouth. The study will monitor the children's health over a period of time to see how well the treatment works. Researchers will look at various factors, such as the duration of fever and symptoms, and whether there is a need for additional antibiotic treatment.

The study aims to provide valuable information on the effectiveness of amoxicillin in treating pneumonia in young children. By comparing the outcomes of those receiving the antibiotic to those receiving a placebo, researchers hope to better understand the role of amoxicillin in managing this common childhood illness.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be assessed to ensure you meet the criteria. This includes being between 12 to 59 months old, having a fever of at least 38.0°C, and showing signs of lower airway inflammation such as a cough or difficulty breathing.
Step 2
Receiving medication
You will be randomly assigned to receive either the antibiotic amoxicillin or a placebo. The medication is in the form of an oral suspension, which means it is a liquid that you drink.
The dosage is 500 mg/5 ml, and you will take it as directed by the study team. The frequency and duration of administration will be explained to you by the healthcare provider.
Step 3
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes checking for any signs of therapy failure, such as the need for additional antibiotics or the persistence of symptoms.
Your parent or guardian will be asked to report on the duration of your fever and any other symptoms you experience.
Step 4
End of treatment evaluation
At the end of the treatment period, which is 21 days after starting the medication, your condition will be evaluated to determine the effectiveness of the treatment.
The study will also assess the presence of bacteria in your airways and any potential resistance to antibiotics.

Who can join the trial?

10 criteria

Age between 12 and 59 months (1 to almost 5 years old).
Has a fever, which means a body temperature of 38.0°C (100.4°F) or higher, either now or within the last 24 hours.
Has tachypnoea, which means breathing faster than normal for their age.
Shows at least one sign of lower airway inflammation, which can include:
- Cough, either now or reported within the last 6 hours.
- Chest retractions, which means the skin pulls in between or under the ribs when breathing.
- Grunting respiration, a sound made when breathing out.
- Nasal flaring, which means the nostrils widen when breathing in.
- Crepitations heard by a doctor using a stethoscope, which are crackling sounds in the lungs.
- Hypoxia, which means low oxygen levels in the blood, specifically an oxygen saturation (SpO2) of 90% or less.
- Weighs between 6.0 kg (about 13 pounds) and 28.0 kg (about 62 pounds).

Who cannot join the trial?

7 criteria

Children who are not in the preschool age group cannot participate.
Children who do not have a lower respiratory tract infection cannot participate. This means the infection is in the lungs or airways below the throat.
Children who have any other serious health conditions that might interfere with the study cannot participate.
Children who are taking certain medications that might affect the study results cannot participate.
Children who have allergies to amoxicillin or similar antibiotics cannot participate. Amoxicillin is a type of medicine used to treat infections.
Children who have participated in another clinical trial recently cannot participate.
Children who are unable to follow the study procedures cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Akershus University Hospital
Verified
Lorenskog, Norway
Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Amoxicillin is an antibiotic used to treat infections caused by bacteria. In this clinical trial, it is being tested to see how well it works in treating pneumonia in preschool children. The goal is to understand if amoxicillin can help children recover from pneumonia more effectively compared to not using the medication.

Amoxicillin Trihydrate

What is already known about the treatment

Amoxicillin – Amoxicillin is an antibiotic that is usually taken orally in the form of a pill or liquid. It is currently well-established in medical practice and literature as a treatment for bacterial infections. The main therapeutic use of amoxicillin is to treat infections like lower respiratory tract infections, including pneumonia. At the molecular level, amoxicillin works by interfering with the bacteria's ability to form cell walls, which ultimately kills the bacteria. It belongs to the pharmacological class of penicillin antibiotics.

Investigated diseases

Lower respiratory tract infection – Lower respiratory tract infection refers to infections that affect the airways below the voice box, including the trachea, bronchi, and lungs. It commonly involves conditions such as bronchitis and pneumonia. The infection typically begins with symptoms like coughing, mucus production, and difficulty breathing. As it progresses, individuals may experience fever, chest discomfort, and fatigue. The severity of symptoms can vary, with some cases leading to more significant breathing difficulties. The infection can be caused by various pathogens, including bacteria and viruses, and may result in inflammation and congestion in the affected areas.