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RECRUITING
NCT06020716
PHASE4

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

Sponsor: Helse Stavanger HF

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

9 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2023-08-16

Completion Date

2028-04-30

Last Updated

2024-12-27

Healthy Volunteers

Yes

Interventions

DRUG

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

Three times daily

DRUG

Placebo

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