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Antibiotics, Microbiology and Immunology in Children with Chronic wet Cough - the AMIC study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500586-27-00
Acronym
AMIC 002
Enrollment
350
Registered
2023-04-19
Start date
2023-08-15
Completion date
Unknown
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic wet cough in young children

Brief summary

Response to treatment of amoxicillin-clavulanate is defined as baseline cough score ≤2 in validated Verbal category descriptive (VCD) cough score at the end of treatment or cessation of coughing (VCD =0) for a minimum period of 3 days within the treatment period. VCD score (0-10 points) will be reported by parents. Baseline cough score is the mean cough score of the three days before start of treatment (days -3 to -1)., Time to relapse is defined as the time from end of treatment (FU1) to start of relapse. Relapse of symptoms is defined as a new period of wet cough - after a period of at least seven days without symptoms - lasting for more than four weeks or an episode of wet cough of at least two weeks duration which was treated with antibiotics by the child’s general practitioner or treating physician. The start of relapse is the first day with cough of such a period or episode.

Detailed description

Respiratory pathogens (virus and bacteria) detected by conventional methods (PCR and culture) in children with CWC and healthy controls., Airway and gut microbiome diversity/composition in children with CWC and healthy controls, Inflammatory markers and patterns of these markers in laryngeal aspirate and peripheral blood from children with CWC compared and healthy controls., Functional markers (not genetics) of Primay immunodeficiencies (PID) (Immunoglobulins, lymphocyte populations, complement function, vaccine response) in children with CWC and healthy controls., Proportion of children diagnosed with primary immunodeficiencies (PID) based on Next-generation sequencing (NGS) panel for PID in children with CWC., Day by day response to treatment (≤2 in VCD score)in those receiving 14 days treatment with amoxicillin-clavulanate and those receiving placebo., Quality of life score in children with CWC and controls., Day by day response to treatment (≤2 in VCD score).

Interventions

DRUGPlacebo granulate
DRUGAugmentin 400 mg/57 mg/5 ml pulver til mikstur
DRUGsuspensjon (blandet fruktsmak)

Sponsors

Stavanger University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Response to treatment of amoxicillin-clavulanate is defined as baseline cough score ≤2 in validated Verbal category descriptive (VCD) cough score at the end of treatment or cessation of coughing (VCD =0) for a minimum period of 3 days within the treatment period. VCD score (0-10 points) will be reported by parents. Baseline cough score is the mean cough score of the three days before start of treatment (days -3 to -1)., Time to relapse is defined as the time from end of treatment (FU1) to start of relapse. Relapse of symptoms is defined as a new period of wet cough - after a period of at least seven days without symptoms - lasting for more than four weeks or an episode of wet cough of at least two weeks duration which was treated with antibiotics by the child’s general practitioner or treating physician. The start of relapse is the first day with cough of such a period or episode.

Secondary

MeasureTime frame
Respiratory pathogens (virus and bacteria) detected by conventional methods (PCR and culture) in children with CWC and healthy controls., Airway and gut microbiome diversity/composition in children with CWC and healthy controls, Inflammatory markers and patterns of these markers in laryngeal aspirate and peripheral blood from children with CWC compared and healthy controls., Functional markers (not genetics) of Primay immunodeficiencies (PID) (Immunoglobulins, lymphocyte populations, complement function, vaccine response) in children with CWC and healthy controls., Proportion of children diagnosed with primary immunodeficiencies (PID) based on Next-generation sequencing (NGS) panel for PID in children with CWC., Day by day response to treatment (≤2 in VCD score)in those receiving 14 days treatment with amoxicillin-clavulanate and those receiving placebo., Quality of life score in children with CWC and controls., Day by day response to treatment (≤2 in VCD score).

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026