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Fosfomycin I.v. for Treatment of Severely Infected Patients

Study acronym: FORTRESS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 46 to 50v17
  2. Study sites: 40 to 46v16
  3. Primary and study completion dates: Dec 2023 to Dec 2030
    • Study sites: 26 to 40
    v15
  4. Re-verified, no change to tracked fieldsv14
  5. Study sites: 22 to 26v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary and study completion dates: Jun 2020 to Dec 2023v12
  2. Site contacts updated at 1 of 22 sitesv11
  3. Study sites: 17 to 22v10
  4. Site contacts updated at 1 of 17 sitesv9
  5. Study sites: 16 to 17v8
  6. Study sites: 14 to 16v7
  7. Study sites: 12 to 14v6
  8. Study sites: 10 to 12v5
  9. Study sites: 7 to 10v4
  10. Study sites: 4 to 7v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 4
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.
Trial Details
NCT Number NCT02979951
Lead Sponsor Infectopharm Arzneimittel GmbH
Collaborators: INPADS GmbH, Dr. Oestreich + Partner GmbH
Conditions
(from sponsor)		 Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis, Brain Abscess, Urinary Tract Infections +8 more
Related terms Bacteremia, Bacterial Infections, Bone Diseases, Infectious, Brain Abscess, Central Nervous System Bacterial Infections, Encephalitis, Endocarditis, Bacterial, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections, Intraabdominal Infections, Meningitis, Bacterial, Osteomyelitis, Pneumonia, Bacterial, Respiratory Tract Infections, Sepsis, Skin Diseases, Bacterial, Soft Tissue Infections, Urinary Tract Infections
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov