Protracted Bacterial Bronchitis study: Amoxicillin-Clavulanate
Official title Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
ClinicalTrials.gov ID: NCT06020716
What this study is testing
What is Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution?
This is an investigational antibiotic medicine being studied to see if it helps children with chronic wet cough. It is designed to fight bacterial infections by stopping bacteria from growing.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if antibiotics work for chronic wet cough and whether a longer course of treatment prevents symptoms from coming back. It also looks at how these medicines affect the bacteria in the airways and gut.
- Who it's for
- The study is looking for children who have a chronic wet cough, a condition often caused by bacteria in the airways.
- What's involved
- Participants will be randomly assigned to take either an antibiotic medicine or a sugar pill (placebo) for 14 or 28 days. They will also provide samples to help researchers study their immune system and bacteria.
- Time commitment
- The treatment phase lasts either 14 or 28 days, with follow-up visits to check for symptom return.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 36. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 9 and \< 36 months.
- Body weight ≥ 7 kg and \< 24 kg.
- Born term with Gestational age ≥ 37 weeks.
- Chronic wet cough for \> 4 weeks at screening and in addition average cough score last 7 days at randomization ≥ 4 points and without signs of...
- Written informed consent obtained from both parents at inclusion.
You likely can't join if
- Gestational age \< 37 weeks.
- History of acute upper or lower airway infection the last 2 weeks.
- History of other viral or bacterial infections the last 2 weeks.
- Episode with temperature above 38 °C during the last 2 weeks.
- Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma...
- Cardiac disease, except persisting foramen ovale or ductus arteriosus.
See the full eligibility criteria
- Age ≥ 9 and \< 36 months.
- Body weight ≥ 7 kg and \< 24 kg.
- Born term with Gestational age ≥ 37 weeks.
- Chronic wet cough for \> 4 weeks at screening and in addition average cough score last 7 days at randomization ≥ 4 points and without signs of another cause. Registration ≥ 5 days is mandatory.
- Written informed consent obtained from both parents at inclusion.
- The study subject must be assessed as eligible for treatment with Augmentin.
- Gestational age \< 37 weeks.
- History of acute upper or lower airway infection the last 2 weeks.
- History of other viral or bacterial infections the last 2 weeks.
- Episode with temperature above 38 °C during the last 2 weeks.
- Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
- Cardiac disease, except persisting foramen ovale or ductus arteriosus.
- Severe feeding problems/aspiration.
- Gastroesophageal reflux suspicion or confirmed by ph measurement.
- Suspicion of hypertrophic tonsils or adenoids
- Episodes of bronchopulmonary obstruction suggesting asthma
- Presence of gross neurodevelopmental delay, or suspicion of neurological disease.
- History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.
- Episodes with haemoptysis and with unknown cause.
- Radiographic changes other than perihilar changes confirmed by x-ray at screening.
- At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.
- Parents unable to speak and/or understand Norwegian language.
- Received systemic antibiotics within the last 6 months before inclusion.
- Participation in another clinical intervention trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Ålesund, Norway
- Bergen, Norway
- Lillestrøm, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 months to 36 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ålesund, Norway; Bergen, Norway; Lillestrøm, Norway; Oslo, Norway; Stavanger, Norway; Tromsø, Norway and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.