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Completed

NCT Number: NCT02683603

Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

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.

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Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

intensive care unit of the University Hospital Center La Rabta

Tunis, Tunis Governorate, 1007, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Critically ill patients older than 18 years, with mechanical ventilation during more than 48 hours, and who have presented a Ventilator associated Pneumonia (VAP) defined as a CPIS (Clinical Pulmonary Infection Score) of more than six

Exclusion criteria

  • Age <18 years
  • Pregnancy
  • Septic shock

Treatment and study plan

AS colistin and "imipenem"

Drug

colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem

Other names: colimycin (colistin) powder (Sanofi laboratories)

IV colistin " and "imipenem" .

Drug

colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem

Other names: colimycin (colistin) powder (Sanofi laboratories)

AS colimycin (colistin)

Drug

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).

Other names: colimycin (colistin)

IV colimycin (colistin)

Drug

intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day

Other names: colimycin (colistin) powder by intravenous route

AS colistin and imipenem

Drug

IV imipenem 1 g three times per day.

Other names: imipenem

IV colistin and imipenem

Drug

IV imipenem 1 g three times per day

Other names: imipenem

Primary outcomes

  1. cure of VAP

    Time frame: day 14 of therapy

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

Secondary outcomes

  1. 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.

  2. duration of mechanical ventilation

    Time frame: From date of randomization until the time of weaning from ventilator, an average of 14 days

  3. length of stay in intensive unit

    Time frame: from randomisation until the time of patient discharge, an average of 28 days

Other outcomes

  1. all cause mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2016
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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