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Bacteriological Evaluation of Children With Otorrhea

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Oct 1, 2025 to Oct 31, 2028v6 Show 5 more changesShow less
    • Primary endpoint revised
    • Interventions: middle ear fluid sample (Other) to middle ear fluid sample for bacterial analysis (conventional microbiology analysis) (Other)
    • Secondary endpoints: 2 to 4
    • Study description revised
    • Publications: 1 to 4
  2. Re-verified, no change to tracked fieldsv5
  3. Enrollment target: 800 to 1500
    • Primary completion date: Jun 1, 2022 to Oct 1, 2025
    • Study completion date: Jan 1, 2025 to Oct 1, 2025
    v4
  4. Primary completion date: Oct 1, 2015 to Jun 1, 2022v3
  5. Re-verified, no change to tracked fieldsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.
Trial Details
NCT Number NCT04807660
Lead Sponsor Association Clinique Thérapeutique Infantile du val de Marne
Conditions
(from sponsor)		 Otorrhea
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov