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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

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-Associated Drug: AS colistin and "imipenem" Drug: IV colistin " and "imipenem" . Drug: AS colimycin (colistin) Drug: IV colimycin (colistin) Drug: AS colistin and imipenem Drug: IV colistin and imipenem Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Toxicity of Aerosolised Colistin in Ventilator Associated Pneumonia: A Prospective, Randomized Trial
Study Start Date : April 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
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%.
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: 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: AS colistin and imipenem
IV imipenem 1 g three times per day.
Other Name: 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.
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: 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: IV colistin and imipenem
IV imipenem 1 g three times per day
Other Name: imipenem




Primary Outcome Measures :
  1. cure of VAP [ Time Frame: day 14 of therapy ]
    a CPIS (clinical pulmonary infection score) less than 6 and bacterial eradication


Secondary Outcome Measures :
  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 Outcome Measures:
  1. all cause mortality [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683603


Locations
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Tunisia
intensive care unit of the University Hospital Center La Rabta
Tunis, Tunisia, 1007
Sponsors and Collaborators
Tunis University
Investigators
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Study Chair: Ahlem Trifi Tunis University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahlem Trifi, doctor, Tunis University
ClinicalTrials.gov Identifier: NCT02683603    
Other Study ID Numbers: Tunis university
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
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
Keywords provided by Ahlem Trifi, Tunis University:
colistin
aerosol
ventilator associated pneumonia
nephrotoxicity
intravenous
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Imipenem
Colistin
Anti-Bacterial Agents
Anti-Infective Agents