Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nebulized Colistin for Gram Negative VAP Prevention.

NCT04208945

Pneumonia, Ventilator-associated Gram-Negative Pneumonia

UNKNOWN NA

Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

NCT00645723

Cross Infection Pneumonia, Bacterial

UNKNOWN PHASE3

Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

NCT02806141

Pneumonia, Ventilator-Associated Colistin Adverse Reaction Infection Due to Multidrug Resistant Acinetobacter +1 more

TERMINATED PHASE3

Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia

NCT02906722

Ventilator-associated Pneumonia

TERMINATED PHASE3

Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)

NCT01292031

Ventilator-associated Bacterial Pneumonia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia, Ventilator-Associated

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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%.

Group Type ACTIVE_COMPARATOR

AS colistin and "imipenem"

Intervention Type DRUG

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

AS colimycin (colistin)

Intervention Type 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).

AS colistin and imipenem

Intervention Type DRUG

IV imipenem 1 g three times per day.

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.

Group Type ACTIVE_COMPARATOR

IV colistin " and "imipenem" .

Intervention Type DRUG

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

IV colimycin (colistin)

Intervention Type DRUG

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

IV colistin and imipenem

Intervention Type DRUG

IV imipenem 1 g three times per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AS colistin and "imipenem"

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

Intervention Type DRUG

IV colistin " and "imipenem" .

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

Intervention Type 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).

Intervention Type DRUG

IV colimycin (colistin)

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

Intervention Type DRUG

AS colistin and imipenem

IV imipenem 1 g three times per day.

Intervention Type DRUG

IV colistin and imipenem

IV imipenem 1 g three times per day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

colimycin (colistin) powder (Sanofi laboratories) colimycin (colistin) powder (Sanofi laboratories) colimycin (colistin) colimycin (colistin) powder by intravenous route imipenem imipenem

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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