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

NCT06020716 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Protracted Bacterial Bronchitis

Interventions

DRUG

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

Three times daily

DRUG

Placebo

Three times daily

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Alesund Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Trondheim University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Knut Øymar, MD PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020716 on ClinicalTrials.gov