Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Recruiting
Phase 4
Interventional Study
Protracted Bacterial Bronchitis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 9 Months – 36 Months
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 350 (estimated)
- Sponsor
- Helse Stavanger HF · Government
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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. Registr…
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