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Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Study acronym: AB-studie
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv16
  2. Notable Primary completion date: Jul 2024 to Oct 2027
    • Study completion date: Jul 2024 to Oct 2033
    v15
  3. Minor 2 versions Re-verified since Nov 21, 2022, no change to tracked fieldsv13-v14
  4. Notable Primary and study completion dates: Jul 2022 to Jul 2024v12
  5. Minor 2 versions Re-verified since Nov 4, 2020, no change to tracked fieldsv10-v11
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary and study completion dates: May 2019 to Jul 2022v9
  2. Notable Primary and study completion dates: May 2017 to May 2019v8
  3. Notable Primary and study completion dates: May 2016 to May 2017v7
  4. Notable Primary and study completion dates: May 2014 to May 2016v6
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Nov 2014 to May 2014
    • Site details revised at 2 of 2 sites
    v5
  6. Minor Interventions: Azithromycin (Drug) to Azithromycin (Drug), Placebo mixture (Other)
    • Study arms: 1 to 2
    v4
  7. Minor Enrollment target: 70
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (8)
    v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.
Trial Details
NCT Number NCT01233297
Lead Sponsor Copenhagen Studies on Asthma in Childhood
Conditions
(from sponsor)
Childhood Asthma With Acute Exacerbation
Related terms Infections, Respiratory Sounds
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov