Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Study populations:

AMIC 1:

90 children with chronic wet cough aged 9-36 months.

AMIC 2:

210 children with chronic wet cough aged 9-36 months.

All children will be followed until 24 months after the start of the Randomized Controlled Trial (RCT).

HEALTHY CONTROL GROUP:

To study the role of respiratory pathogens, airway and gut microbiome, inflammation and immunology, 50 healthy controls will be included for comparison to AMIC 1. The healthy controls will have a second visit 6 months after inclusion.

Conditions

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Protracted Bacterial Bronchitis

Keywords

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Chronic wet cough Antibiotic Children Microbiology Immunology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase 4, randomized controlled, parallel group, multicenter, double blind study of amoxicillin-clavulanate in children 9-36 months of age with chronic wet cough. A total of 300 children will be included in the study in two different RCTs; AMIC 1 and AMIC 2.AMIC 1 will be performed before AMIC 2.There is no randomization between AMIC 1 and AMIC 2.

To study the role of respiratory pathogens, microbiome and inflammation, 50 healthy controls will be included for comparison.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Three times daily

Intervention Type DRUG

Placebo

Three times daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Knut Øymar, MD PhD

Role: STUDY_CHAIR

Helse Stavanger HF

Identifier Source: secondary_id

AMIC 2023

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

AMIC 1: Arm A

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

AMIC 1: Arm B

Placebo

AMIC 2: Arm C

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

Placebo

AMIC 2: Arm D

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

Interventions

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

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Oslo University Hospital

Haukeland University Hospital

Alesund Hospital

University Hospital, Akershus

Trondheim University Hospital

University Hospital of North Norway

Helse Stavanger HF

Responsible Party

Principal Investigators

Knut Øymar, MD PhD

Locations

Ålesund Hospital

Haukeland University Hospital

Akershus University Hospital

Oslo University Hospital

Stavanger University Hospital

University Hospital of North-Norway

Trondheim University Hospital

Countries

Central Contacts

Knut Øymar, MD PhD

Ingvild B Mikalsen, MD PhD

Facility Contacts

Torbjørn Nag, MD

Asle Hirt, PhD

Chris Inchley, PhD

Håvard Skjerven, Professor

Per Kristian Knudsen, PhD

Ingvild B Mikalsen, Ass.Prof

Knut Øymar, Prof

Claus Klingenberg, Professor

Henrik Døllner, Professor

Other Identifiers

2022-500586-27-00

AMIC 2023