Using antibiotics to treat chronic wet cough in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The AMIC study investigates the effectiveness of antibiotics in treating chronic wet cough in children aged 9 to 36 months. It is a double-blind, placebo-controlled, multicenter trial that aims to determine the impact of antibiotic treatment duration on symptom relief and relapse rates. Additionally, the study will analyze respiratory pathogens and the microbiome in affected children compared to healthy controls, as well as explore the role of inflammation and genetics in this condition. Participants will be followed for up to 24 months to assess long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 9 and \< 36 months.
2. Body weight ≥ 7 kg and \< 24 kg.
3. Born term with Gestational age ≥ 37 weeks.
4. 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.
5. Written informed consent obtained from both parents at inclusion.
6. The study subject must be assessed as eligible for treatment with Augmentin.

Exclusion Criteria:

1. Gestational age \< 37 weeks.
2. History of acute upper or lower airway infection the last 2 weeks.
3. History of other viral or bacterial infections the last 2 weeks.
4. Episode with temperature above 38 °C during the last 2 weeks.
5. Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
6. Cardiac disease, except persisting foramen ovale or ductus arteriosus.
7. Severe feeding problems/aspiration.
8. Gastroesophageal reflux suspicion or confirmed by ph measurement.
9. Suspicion of hypertrophic tonsils or adenoids
10. Episodes of bronchopulmonary obstruction suggesting asthma
11. Presence of gross neurodevelopmental delay, or suspicion of neurological disease.
12. History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.
13. Episodes with haemoptysis and with unknown cause.
14. Radiographic changes other than perihilar changes confirmed by x-ray at screening.
15. At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.
16. Parents unable to speak and/or understand Norwegian language.
17. Received systemic antibiotics within the last 6 months before inclusion.
18. Participation in another clinical intervention trial.

Where it's running

• Ålesund Hospital
  Ålesund, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting
• Akershus University Hospital
  Lillestrøm, Norway Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting
• Stavanger University Hospital
  Stavanger, Norway Recruiting
• University Hospital of North-Norway
  Tromsø, Norway Recruiting

Study contacts

• Study coordinator: Knut Øymar, MD PhD
• Email: knut.oymar@sus.no
• Phone: +47 41633426

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.