RecruitingPhase 4NCT06020716

Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study

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.


Sponsor

Helse Stavanger HF

Enrollment

350 participants

Start Date

Aug 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 9 MonthsMax Age: 36 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution and a drug called Placebo for people with protracted bacterial bronchitis. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution

Three times daily

DRUGPlacebo

Three times daily


Locations(7)

Ålesund Hospital

Ålesund, Norway

Haukeland University Hospital

Bergen, Norway

Akershus University Hospital

Lillestrøm, Norway

Oslo University Hospital

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

University Hospital of North-Norway

Tromsø, Norway

Trondheim University Hospital

Trondheim, Norway

View Full Details on ClinicalTrials.gov

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NCT06020716


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