NCT02683603

Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Tunis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pneumonia, Ventilator-Associated

Interventions

Type	Name	Description
DRUG	AS colistin and "imipenem"	colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem
DRUG	IV colistin " and "imipenem" .	colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem
DRUG	AS colimycin (colistin)	nebulisation of colimycin (colistin) for 30 minutes 3 times per day during at least 14 days. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland).
DRUG	IV colimycin (colistin)	intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day
DRUG	AS colistin and imipenem	IV imipenem 1 g three times per day.
DRUG	IV colistin and imipenem	IV imipenem 1 g three times per day

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2016-02-17
• Last updated: 2016-02-17

Locations

1 site across 1 country: Tunisia