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Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

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ClinicalTrials.gov Identifier: NCT02683603
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ahlem Trifi, Tunis University

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
cure of VAP [ Time Frame: day 14 of therapy ]
a CPIS (clinical pulmonary infection score) less than 6 and bacterial eradication
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 16, 2016)
all cause mortality [ Time Frame: 28 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Aerosolised Colistin in Ventilator Associated Pneumonia
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia, Ventilator-Associated
Intervention  ICMJE
  • Drug: AS colistin and "imipenem"
    colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem
    Other Name: colimycin (colistin) powder (Sanofi laboratories)
  • Drug: IV colistin " and "imipenem" .
    colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem
    Other Name: colimycin (colistin) powder (Sanofi laboratories)
  • 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).
    Other Name: colimycin (colistin)
  • Drug: IV colimycin (colistin)
    intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day
    Other Name: colimycin (colistin) powder by intravenous route
  • Drug: AS colistin and imipenem
    IV imipenem 1 g three times per day.
    Other Name: imipenem
  • Drug: IV colistin and imipenem
    IV imipenem 1 g three times per day
    Other Name: imipenem
Study Arms  ICMJE
  • Active Comparator: aerosolised (AS) colistin group
    the intervention was: AS colistin and "imipenem. the drug administered was colimycin (colistin) powder 1 million units (MU) by a flakon (Sanofi Winthrop Industry) at the dosage of 4 million units (MU) for 30 minutes 3 times per day for at least 14 days in addition to IV imipenem 1 g three times per day. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland). Inhaled colimycin® requires specific settings of the ventilator to limit turbulence inspiratory flow. The adjustment consisted in a volume controlled mode with a Tidal volume <8 ml / kg, respiratory rate at 12 cycles / min, I / E: 1/1 and an end inspiratory break > 20%.
    Interventions:
    • Drug: AS colistin and "imipenem"
    • Drug: AS colimycin (colistin)
    • Drug: AS colistin and imipenem
  • Active Comparator: intravenous (IV) colistin goup
    the intervention was: IV colistin and "imipenem. the intravenous (IV) colistin goup received IV colimycin (colistin) as a loading dose of 9 MU during 60 minutes followed by 4.5 million units 2 times per day in addition to IV imipenem 1 g three times per day.
    Interventions:
    • Drug: IV colistin " and "imipenem" .
    • Drug: IV colimycin (colistin)
    • Drug: IV colistin and imipenem
Publications * Abdellatif S, Trifi A, Daly F, Mahjoub K, Nasri R, Ben Lakhal S. Efficacy and toxicity of aerosolised colistin in ventilator-associated pneumonia: a prospective, randomised trial. Ann Intensive Care. 2016 Dec;6(1):26. doi: 10.1186/s13613-016-0127-7. Epub 2016 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2016)
133
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683603
Other Study ID Numbers  ICMJE Tunis university
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: yes of course the data is collected on individual cards which identified demographic, clinical and laboratory data for each patient participating. thereafter these data is entered on Statistical Package for Social Sciences (SPSS) software
Responsible Party Ahlem Trifi, Tunis University
Study Sponsor  ICMJE Tunis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahlem Trifi Tunis University
PRS Account Tunis University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP