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Pneumonia, Ventilator-AssociatedPhase 4NCT02683603

Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

A Phase 4 study testing AS colistin and "imipenem", IV colistin " and "imipenem" . and AS colimycin (colistin) in people with Pneumonia, Ventilator-Associated, run by Tunis University at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Ventilator-Associated
What is being tested?
AS colistin and "imipenem", IV colistin " and "imipenem" . and AS colimycin (colistin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteTunisia
Study dates
Apr 2013to Apr 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Age <18 years
  • Pregnancy
  • Septic shock

Trial locations and contacts

1 site in 1 country.

Tunisia1 site

  • intensive care unit of the University Hospital Center La Rabta

    Tunis, Tunis Governorate, 1007

Other trials in Tunisia

About this study

Official title: Efficacy and Toxicity of Aerosolised Colistin in Ventilator Associated Pneumonia: A Prospective, Randomized Trial

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.

Read the 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.

Being tested
AS colistin and "imipenem", IV colistin " and "imipenem" ., AS colimycin (colistin), IV colimycin (colistin), AS colistin and imipenem
Keywords
colistin, aerosol, ventilator associated pneumonia, nephrotoxicity, intravenous
Medical subject headings
Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AS colistin and "imipenem"Drug

    Also called colimycin (colistin) powder (Sanofi laboratories)

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

  • IV colistin " and "imipenem" .Drug

    Also called colimycin (colistin) powder (Sanofi laboratories)

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

  • AS colimycin (colistin)Drug

    Also called 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).

  • IV colimycin (colistin)Drug

    Also called colimycin (colistin) powder by intravenous route

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

  • AS colistin and imipenemDrug

    Also called imipenem

    IV imipenem 1 g three times per day.

  • IV colistin and imipenemDrug

    Also called imipenem

    IV imipenem 1 g three times per day

Study groups in NCT02683603
Study groupRoleWhat they receive
aerosolised (AS) colistin groupActive comparatorthe 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%.
Receives: Drug: AS colistin and "imipenem"; Drug: AS colimycin (colistin); Drug: AS colistin and imipenem
intravenous (IV) colistin goupActive comparatorthe 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.
Receives: Drug: IV colistin " and "imipenem" .; Drug: IV colimycin (colistin); Drug: IV colistin and imipenem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cure of VAP

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

    Measured: day 14 of therapy

Secondary outcomes (3)

  1. occurrence of acute renal failure

    an acute renal failure was defined as increase of plasma creatinine more than 1.5 times its base value.

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

  2. duration of mechanical ventilation

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

  3. length of stay in intensive unit

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2016 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02683603
Sponsor's protocol ID
Tunis university
Status last verified
Feb 2016
First submitted
5 Feb 2016
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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

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.

    PubMed 27033711

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AS colistin and "imipenem", IV colistin " and "imipenem" . and AS colimycin (colistin) in people with Pneumonia, Ventilator-Associated, run by Tunis University at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cure of VAP (time frame: day 14 of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683603, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.

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