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Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis

Study acronym: ANTEIPA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Site details revised at 3 of 18 sitesv6
  3. Minor Site details revised at 3 of 18 sitesv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 18 of 18 sites
    v4
  5. Notable Start date: Jun 1, 2024 to Sep 15, 2024
    • Study sites: 16 to 18
    • Primary completion date: Nov 1, 2024 to Mar 15, 2025
    • Study completion date: Jun 1, 2028 to Sep 15, 2028
    v3
  6. Notable Start date: May 1, 2024 to Jun 1, 2024
    • Study completion date: May 1, 2028 to Jun 1, 2028
    • Interventions: Bitherapy treatment and follow-up (Drug), Monotherapy treatment and follow-up (Drug) to Antibiotic bitherapy treatment and follow-up (Drug), Antibiotic monotherapy treatment and follow-up (Drug)
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact.
Trial Details
NCT Number NCT06368804
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators: Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Bronchiectasis
Related terms Bronchiectasis
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov