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Study on the Effectiveness of Amoxicillin and Clavulanic Acid in Treating Chronic Wet Cough in Young Children

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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 young children who have a persistent cough that produces mucus, known as a chronic wet cough. The treatment being tested is a medication called Augmentin, which is a combination of two substances: amoxicillin and clavulanic acid. These substances work together to fight bacterial infections. The study will compare the effects of this medication to a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to see if children with a chronic wet cough improve more when they take Augmentin for 14 days compared to those who take a placebo. Additionally, the study will explore whether extending the treatment to 28 days affects the time it takes for the cough to return. The study will also look at how the bacteria in the airways and gut, as well as inflammation and genetics, might influence the cough and its treatment.

Participants in the study will receive either the medication or the placebo for a set period. Researchers will monitor the children's symptoms and any changes in their cough. The study will also examine the presence of bacteria and viruses, the diversity of bacteria in the airways and gut, and markers of inflammation in the body. The goal is to understand how these factors relate to the cough and its treatment, and to assess the overall quality of life for the children involved.

The research process

The trial runs in 6 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, the participant will be assessed to ensure they meet the necessary criteria. This includes being between the ages of 9 and 36 months, weighing between 7 kg and 24 kg, and having a chronic wet cough for more than 4 weeks. Written consent from both parents is required.
Step 2
Initial assessment
The participant's cough will be evaluated using a **verbal category descriptive (VCD) cough score**. This score ranges from 0 to 10, with parents reporting the average score over the three days before treatment begins.
Step 3
Treatment phase
Participants will receive either **amoxicillin-clavulanate** or a placebo. The medication is administered as an **oral suspension** with a mixed fruit flavor. The dosage is 400 mg/57 mg per 5 ml.
The treatment will last for either 14 or 28 days, depending on the group assignment. The purpose is to determine if the response to treatment is higher in those receiving the antibiotic compared to the placebo.
Step 4
Monitoring and reporting
Throughout the treatment, parents will report the participant's cough score daily. A response to treatment is defined as a reduction in the cough score to 2 or less, or the cessation of coughing for at least 3 days during the treatment period.
Step 5
Follow-up
After the treatment phase, the participant will be monitored for any relapse of symptoms. A relapse is defined as a new period of wet cough lasting more than four weeks or an episode of at least two weeks that requires antibiotic treatment.
Step 6
Final assessment
The study will conclude with a final assessment of the participant's health and any changes in their condition. This includes evaluating the diversity and composition of the airway and gut microbiome, as well as any inflammatory markers.

Who can join the trial?

8 criteria

Child's age must be more than 9 months and less than 36 months.
Child's body weight must be more than 7 kg and less than 24 kg.
Child must have been born at full term, which means after 37 weeks of pregnancy.
Child must have a chronic wet cough for more than 4 weeks at the time of screening. This means a cough that produces mucus and has been ongoing for a long time.
The average cough score over the last 7 days must be 4 points or more, and there should be no signs of another cause for the cough.
Registration for the study must be at least 5 days before starting.
Both parents must provide written informed consent, which means they agree to let their child participate in the study after understanding all the details.
The child must be eligible for treatment with Augmentin, which is a type of antibiotic medication.

Who cannot join the trial?

8 criteria

Children who do not have a chronic wet cough. A chronic wet cough is a cough that produces mucus and lasts for a long time.
Children who are not within the age range specified for the study.
Children who have other medical conditions that might interfere with the study.
Children who are currently taking medications that could affect the study results.
Children who have allergies to the study medication, which is amoxicillin-clavulanate. This is a type of antibiotic used to treat infections.
Children who have participated in another clinical trial recently.
Children who have a history of severe reactions to antibiotics.
Children who are unable to follow the study procedures for any reason.

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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
Helse Bergen HF
Verified
Bergen, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

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Investigated drugs

Amoxicillin-Clavulanate is a combination antibiotic used in this study to treat children with chronic wet cough. It works by killing bacteria that may be causing the cough. Amoxicillin is a type of penicillin that fights bacteria, while clavulanate helps prevent certain bacteria from becoming resistant to amoxicillin. In this trial, researchers are investigating whether taking this medication for 14 days helps improve symptoms more effectively than not taking it. They are also studying if extending the treatment to 28 days affects how quickly symptoms return after stopping the medication.

What is already known about the treatment

Amoxicillin-Clavulanate – This medication is administered orally in the form of tablets or liquid suspension and is used to treat infections. In the context of the AMIC study, it is being evaluated for its effectiveness in treating chronic wet cough in young children. The main therapeutic indication is to help resolve symptoms of this persistent cough and potentially improve long-term outcomes. At the molecular level, amoxicillin works by interfering with the formation of bacterial cell walls, leading to the death of the bacteria, while clavulanate helps prevent certain bacteria from becoming resistant to amoxicillin. It is classified as a combination antibiotic, specifically a penicillin-type antibiotic combined with a beta-lactamase inhibitor.

Investigated diseases

Chronic Wet Cough – Chronic wet cough is a persistent cough that produces phlegm or mucus and lasts for an extended period, typically more than four weeks. It is often seen in young children and can be a sign of underlying respiratory issues. The cough is characterized by a wet or productive sound, indicating the presence of mucus in the airways. Over time, the cough may fluctuate in intensity and frequency, sometimes improving temporarily before worsening again. The condition can be associated with repeated respiratory infections or inflammation in the airways. It may also be linked to environmental factors or underlying health conditions affecting the respiratory system.