Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

NCT02683603 | Completed Phase 4 DMC

• 1 other identifier: Tunis university
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-Associated

Keywords

colistin; aerosol; ventilator associated pneumonia; nephrotoxicity; intravenous

Outcome Measures

Primary Outcomes (1)

• cure of VAP

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

  day 14 of therapy

Secondary Outcomes (3)

• occurrence of acute renal failure

  From date of randomization until the time of the cessation of colistin, assessed up 14 days on average

• duration of mechanical ventilation

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

• length of stay in intensive unit

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

Other Outcomes (1)

• all cause mortality

  28 days

Study Arms (2)

aerosolised (AS) colistin group

ACTIVE COMPARATOR

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"; Drug: AS colimycin (colistin); Drug: AS colistin and imipenem

intravenous (IV) colistin goup

ACTIVE COMPARATOR

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" .; Drug: IV colimycin (colistin); Drug: IV colistin and imipenem

Interventions

AS colistin and imipenem DRUG

IV imipenem 1 g three times per day.

Also known as: imipenem

aerosolised (AS) colistin group

IV colistin and imipenem DRUG

IV imipenem 1 g three times per day

Also known as: imipenem

intravenous (IV) colistin goup

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).

Also known as: colimycin (colistin)

aerosolised (AS) colistin group

IV colimycin (colistin) DRUG

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

Also known as: colimycin (colistin) powder by intravenous route

intravenous (IV) colistin goup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Pregnancy
• Septic shock

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

intensive care unit of the University Hospital Center La Rabta

Tunis, Tunis Governorate, 1007, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 27033711 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Colistin; Imipenem; Powders

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ahlem Trifi

  Tunis University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 17, 2016
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)