Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia

Condition(s) studied

Investigational drug(s) / intervention(s)

Short-treatment of any active antibiotic regimen: 7 days of any active antibiotic treatment for BSI-PA

Long-treatment of any active antibiotic regimen: 14 days of any active antibiotic treatment for BSI-PA

Study summary

Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).

Eligibility

Primary outcome measure(s)

• Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group — 30 days after treatment withdrawal
  Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps: 1. A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: 1. Healing without incidences. 2. Healing with a proven or probable recurrence. 3. Healing with a serious adverse event. 4. No clinical cure. 5. Death. 2. A second classification in which patients from the same clinical outcome category are ranked according to the number of days of antibiotic treatment (RADAR). Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment.

Trial sites (37)

More Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials in Spain

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