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The AMIC study
EU CTIS ID: 2022-500586-27-00
What this study is testing
The overall aims of the AMIC study are to study the clinical efficacy of antibiotics in children with CWC with respect to resolution of symptoms and long-term outcomes as well as the impact of airway and gut microbiome, inflammation and genetics. 1.1 Intervention 1: Is response to treatment in children with CWC higher in those receiving 14 days treatment with amoxicillin-clavulanate than placebo? 1.2 Intervention 2: Is the time to relapse of CWC different for those having received 14 days duration of therapy compared to those having received 28 days duration of therapy with amoxicillin-clavulanate?
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 9 and younger than 36 months.
- Body weight > 7 kg - < 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 inclusion ≥ 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 eligble for treatment with Augmentin.
You likely can't join if
- Gestational age < 37 weeks
- 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.
See the full eligibility criteria
- Age > 9 and younger than 36 months.
- Body weight > 7 kg - < 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 inclusion ≥ 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 eligble for treatment with Augmentin.
- Gestational age < 37 weeks
- 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.
- 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
The study team makes the final eligibility decision.
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 - 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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.