A Phase 4 interventional study of Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution and Placebo in Protracted Bacterial Bronchitis, sponsored by Helse Stavanger HF. Recruiting at 7 sites in Norway. Open to participants aged 9 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Helse Stavanger HF · Phase 4, Interventional, and Treatment
The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial.
OVERALL PRIMARY OBJECTIVES:
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.
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.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's planned enrollment of 350 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
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.
Drug: Placebo
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.
Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution · Drug: Placebo
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.
Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
Three times daily
Three times daily
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.
Time frame: Response to treatment will be assessed 14 days after end of antibiotic treatment
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.
Time frame: Relapse of symptoms will be assessed up to 24 months after end of antibiotic treatment
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Apr 2028, 56 months after the start.
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Helse Stavanger HF