Using antibiotics to treat chronic wet cough in children

A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough.

This study is testing whether giving antibiotics can help young children with a long-lasting wet cough feel better and reduce the chances of their symptoms coming back.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 9 Months to 36 Months
• Sex: All
• Sponsor: Helse Stavanger HF (Government)
• Locations: 7 sites (Ålesund and 6 other locations)
• Trial ID: NCT06020716 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 9 to 36 months with chronic wet cough lasting more than four weeks.

Not a fit: Patients with a history of chronic lung diseases or recent infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for children suffering from chronic wet cough, potentially reducing symptoms and improving quality of life.

How similar studies have performed: Other studies have shown promise in using antibiotics for respiratory conditions, but this specific approach in young children with chronic wet cough is relatively novel.

Eligibility criteria

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 this trial is running

Ålesund and 6 other locations

• 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)
• Trondheim University Hospital — Trondheim, Norway (Recruiting)

Study contacts

• Study coordinator: Knut Øymar, MD PhD

Conditions Protracted Bacterial Bronchitis; Chronic wet cough; Antibiotic; Children; Microbiology; Immunology