Clinical Trial: Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Toxicity of Aerosolised Colistin in Ventilator Associated Pneumonia: A Prospective, Randomized Trial

Brief Summary: the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be tried. Several recent data emphasize the interest of inhaled route. The investigators purpose was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator associated pneumonia.

Detailed Summary: prospective, randomized, single-blind study comparing two groups of patients treated with aerosolised (AS) colistin versus colistin intravenously (IV). Included were patients who have mechanical ventilation over 48 hours and that have developed a VAP. A VAP was defined as a CPIS (Clinical Pulmonary Infection Score) >6. Exclusion criteria were septic shock and/or bacteraemia. Included patients were divided into two randomized groups. The 1st received colistin in AS as 4 MU by nebulisation 3 times per 24 h. The 2nd received colistin in IV as a loading dose of 9 MU followed by 4.5MU two times per 24 h. Colistin was given for 14 days or until extubation. Patients were followed for 28 days. Therapeutic efficacy was assessed by a primary outcome: the cure of VAP at day 14 of therapy and defined as resolution of clinical and biological signs of infection that means a CPIS< 6 and bacteriological eradication. Secondary outcomes: duration of mechanical ventilation, ICU stay-length and mortality at day 28. Systemic toxicity was assessed by the occurrence of acute renal failure (ARF) defined as increase of plasma creatinine more than 1.5 times its base value.
Sponsor: Tunis University

Current Primary Outcome: cure of VAP [ Time Frame: day 14 of therapy ]

a CPIS (clinical pulmonary infection score) less than 6 and bacterial eradication


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • occurrence of acute renal failure [ Time Frame: From date of randomization until the time of the cessation of colistin, assessed up 14 days on average ]
    an acute renal failure was defined as increase of plasma creatinine more than 1.5 times its base value.
  • duration of mechanical ventilation [ Time Frame: From date of randomization until the time of weaning from ventilator, an average of 14 days ]
  • length of stay in intensive unit [ Time Frame: from randomisation until the time of patient discharge, an average of 28 days ]


Original Secondary Outcome: Same as current

Information By: Tunis University

Dates:
Date Received: February 5, 2016
Date Started: April 2013
Date Completion:
Last Updated: February 16, 2016
Last Verified: February 2016