NCT06020716 Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
| NCT ID | NCT06020716 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Helse Stavanger HF |
| Condition | Protracted Bacterial Bronchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2023-08-16 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial. OVERALL PRIMARY OBJECTIVES: * To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC). * To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms. OVERALL SECONDARY OBJECTIVE: -To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics. OVERALL TERTIARY OBJECTIVE: -To study the role of inflammation, immunology, and genetics in children with chronic wet cough and suspicion of PBB to increase the knowledge of pathophysiological mechanisms associated with PBB. The study will include two different RCTs AMIC 1 and AMIC 2: AMIC 1: Participants will be randomly assigned to 14 days amoxicillin-clavulanate syrup or placebo. AMIC 2: Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup.
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.
Contact & Investigator
Knut Øymar, MD PhD
STUDY CHAIR
Helse Stavanger HF
Frequently Asked Questions
Who can join the NCT06020716 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 36 Months, studying Protracted Bacterial Bronchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06020716 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06020716 currently recruiting?
Yes, NCT06020716 is actively recruiting participants. Contact the research team at knut.oymar@sus.no for enrollment information.
Where is the NCT06020716 trial being conducted?
This trial is being conducted at Ålesund, Norway, Bergen, Norway, Lillestrøm, Norway, Oslo, Norway and 3 additional locations.
Who is sponsoring the NCT06020716 clinical trial?
NCT06020716 is sponsored by Helse Stavanger HF. The principal investigator is Knut Øymar, MD PhD at Helse Stavanger HF. The trial plans to enroll 350 participants.