Protracted Bacterial BronchitisPhase 4AMICNCT06020716
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
A Phase 4 study testing Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution in people with Protracted Bacterial Bronchitis, run by Helse Stavanger HF at 7 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Protracted Bacterial Bronchitis
- What is being tested?
- Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 7 sitesNorway
- Study dates
- 16 Aug 2023to 30 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 9 and < 36 months.
- Body weight ≥ 7 kg and < 24 kg.
- Born term with Gestational age ≥ 37 weeks.
- 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.
- Written informed consent obtained from both parents at inclusion.
- The study subject must be assessed as eligible for treatment with Augmentin.
Who cannot join
- Gestational age < 37 weeks.
- History of acute upper or lower airway infection the last 2 weeks.
- History of other viral or bacterial infections the last 2 weeks.
- Episode with temperature above 38 °C during the last 2 weeks.
- Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
- Cardiac disease, except persisting foramen ovale or ductus arteriosus.
Show all 18Show fewer
- Severe feeding problems/aspiration.
- Gastroesophageal reflux suspicion or confirmed by ph measurement.
- Suspicion of hypertrophic tonsils or adenoids
- Episodes of bronchopulmonary obstruction suggesting asthma
- Presence of gross neurodevelopmental delay, or suspicion of neurological disease.
- History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.
- Episodes with haemoptysis and with unknown cause.
- Radiographic changes other than perihilar changes confirmed by x-ray at screening.
- At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.
- Parents unable to speak and/or understand Norwegian language.
- Received systemic antibiotics within the last 6 months before inclusion.
- Participation in another clinical intervention trial.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Norway7 sites, 7 recruiting
- Recruiting
Ålesund Hospital
Ålesund
Torbjørn Nag, MD, Torbjorn.Nag@helse-mr.no
- Recruiting
Haukeland University Hospital
Bergen
Asle Hirt, PhD, asle.hirth@helse-bergen.no
- Recruiting
Akershus University Hospital
Lillestrøm
Chris Inchley, PhD, Christopher.Stephen.Inchley@ahus.no
- Recruiting
Oslo University Hospital
Oslo
Håvard Skjerven, Professor, uxskjh@ous-hf.no
Per Kristian Knudsen, PhD, uxpekn@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger, 40
Ingvild B Mikalsen, Ass.Prof, +4790203676, miib@sus.no
Knut Øymar, Prof, +4741633426, knut.oymar@sus.no
- Recruiting
University Hospital of North-Norway
Tromsø
Claus Klingenberg, Professor, Claus.Klingenberg@unn.no
- Recruiting
Trondheim University Hospital
Trondheim
Henrik Døllner, Professor, henrik.dollner@ntnu.no
About this study
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.
The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial.
OVERALL PRIMARY OBJECTIVES:
Read more
- 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.
Read the detailed description
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
- Protracted Bacterial Bronchitis
- Being tested
- Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution, Placebo
- Keywords
- Chronic wet cough, Antibiotic, Children, Microbiology, Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for ReconstitutionDrug
Three times daily
PlaceboDrug
Three times daily
| Study group | Role | What they receive |
|---|---|---|
| AMIC 1: Arm A | Experimental | In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (Arm A and B) for 14 days. AMIC 1 Arm A will receive 14 days amoxicillin-clavulanate syrup. Receives: Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution |
| AMIC 1: Arm B | Placebo comparator | In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (arm A and B) for 14 days. AMIC 1 Arm B will receive 14 days placebo syrup. Receives: Drug: Placebo |
| AMIC 2: Arm C | Experimental | In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo. Receives: Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution; Drug: Placebo |
| AMIC 2: Arm D | Experimental | In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm D will receive 28 days amoxicillin-clavulanate syrup. Receives: Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Response to treatment is defined as an improvement in baseline validated Verbal category descriptive (VCD) cough score ≤2 at the end of treatment or cessation of coughing for a minimum period of 3 days within the treatment period.The VCD score has a minimum and maxiumum score ranging from 0-10 points, and a higher value corresponds to more severe cough.
Measured: Response to treatment will be assessed 14 days after end of antibiotic treatment
Secondary outcomes (1)
Relapse of symptoms
Relapse of symptoms after antibiotic treatment for chronic wet cough is defined as a new period of wet cough - after a period of at least 7 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 of cough of such a period or episode.
Measured: Relapse of symptoms will be assessed up to 24 months after end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start16 Aug 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protracted Bacterial BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Alesund Hospital, University Hospital, Akershus, Trondheim University Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Knut Øymar, MD PhD, Study chair, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020716
- Sponsor's protocol ID
- AMIC 2023
- Other IDs
- 2022-500586-27-00
- Acronym
- AMIC
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06020716
- Acronym / sponsor ID
- AMIC / AMIC 2023
- Conditions
- Protracted Bacterial Bronchitis
- Keywords
- Chronic wet cough, Antibiotic, Children, Microbiology, Immunology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Alesund Hospital, University Hospital, Akershus, Trondheim University Hospital, University Hospital of North Norway
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AMIC 1: Arm A | Experimental | Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for ReconstitutionIn AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (Arm A and B) for 14 days. AMIC 1 Arm A will receive 14 days amoxicillin-clavulanate syrup. |
| AMIC 1: Arm B | Placebo comparator | Drug: PlaceboIn AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (arm A and B) for 14 days. AMIC 1 Arm B will receive 14 days placebo syrup. |
| AMIC 2: Arm C | Experimental | Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution, Drug: PlaceboIn AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo. |
| AMIC 2: Arm D | Experimental | Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for ReconstitutionIn AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm D will receive 28 days amoxicillin-clavulanate syrup. |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ≥ 9 and < 36 months.
- Body weight ≥ 7 kg and < 24 kg.
- Born term with Gestational age ≥ 37 weeks.
- 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.
- Written informed consent obtained from both parents at inclusion.
Key exclusion criteria (18 listed)
- Gestational age < 37 weeks.
- History of acute upper or lower airway infection the last 2 weeks.
- History of other viral or bacterial infections the last 2 weeks.
- Episode with temperature above 38 °C during the last 2 weeks.
- Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for ReconstitutionThree times daily | Drug | AMIC 1: Arm A, AMIC 2: Arm C, AMIC 2: Arm D |
| PlaceboThree times daily | Drug | AMIC 1: Arm B, AMIC 2: Arm C |
Primary outcome
Response to treatment
Time frame: Response to treatment will be assessed 14 days after end of antibiotic treatment
Response to treatment is defined as an improvement in baseline validated Verbal category descriptive (VCD) cough score ≤2 at the end of treatment or cessation of coughing for a minimum period of 3 days within the treatment period.The VCD score has a minimum and maxiumum score ranging from 0-10 points, and a higher value corresponds to more severe cough.
1 secondary outcome
Relapse of symptoms
Time frame: Relapse of symptoms will be assessed up to 24 months after end of antibiotic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Knut Øymar, MD PhD study chair
Helse Stavanger HF
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution in people with Protracted Bacterial Bronchitis, run by Helse Stavanger HF at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Knut Øymar, MD PhD (+47 41633426, knut.oymar@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: Response to treatment will be assessed 14 days after end of antibiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.