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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS colistin and "imipenem" | Drug | colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem |
|
| Measure | Description | Time Frame |
|---|---|---|
| cure of VAP | a CPIS (clinical pulmonary infection score) less than 6 and bacterial eradication | day 14 of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of acute renal failure | an acute renal failure was defined as increase of plasma creatinine more than 1.5 times its base value. | From date of randomization until the time of the cessation of colistin, assessed up 14 days on average |
| duration of mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahlem Trifi | Tunis University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| intensive care unit of the University Hospital Center La Rabta | Tunis | Tunis Governorate | 1007 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27033711 | Derived | 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. |
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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
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| D015378 | Imipenem |
| D011208 | Powders |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| IV colistin " and "imipenem" . | Drug | colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem |
|
|
| 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). |
|
|
| IV colimycin (colistin) | Drug | intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day |
|
|
| AS colistin and imipenem | Drug | IV imipenem 1 g three times per day. |
|
|
| IV colistin and imipenem | Drug | IV imipenem 1 g three times per day |
|
|
| 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 |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |