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Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 2025 → Dec 31, 2027
See other at-risk trials from Helsinki University Central Hospital

Record History

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  1. Primary completion pushed from Dec 2025 to Dec 31, 2027
    • Study completion date: Dec 2030 to Dec 31, 2030
    • Eligibility criteria expanded, about 7 words
  2. Study sites: 5 to 6
    • Collaborators: 4 to 5
    v5
  3. Site contacts updated at 2 of 5 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2022 to Sep 5, 2022
    • Site details revised at 5 of 5 sites
    v3
  5. Interventions: Azithromycin Pill (Drug), Placebo (Drug) to Azithromycin Pill + Cefuroxime (Drug), Placebo + Cefuroxime (Drug)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
Trial Details
NCT Number NCT05337566
Lead Sponsor Helsinki University Central Hospital
Collaborators: University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
Conditions
(from sponsor)		 Infection Post Op, Hysterectomy, Antibiotics, Prophylactic
Related terms Infections
Enrollment 2,278 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov