Ventilator Associated PneumoniaPhase 2/3NCT03622450
The Effect of Colistin Inhalation on Ventilator Associated Pneumonia
A Phase 2/3 study testing Colistin and Carbapenem + Aminoglycoside/ Quinolone in people with Ventilator Associated Pneumonia, run by Nourhan Hassan Osama Thuraya Mohamed.
Trial summary
The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Colistin and Carbapenem + Aminoglycoside/ Quinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 10 Jan 2018
- Phase
- Phase 2/3
- 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
- Age 18 years
- Patients presenting with signs of infection 48 hours of intubation
Who cannot join
- Patients with documented bronchiectasis
- Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.
- Patients with creatinine clearance less than 30ml/min.
About this study
Official title: The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Colistin, Carbapenem + Aminoglycoside/ Quinolone
- 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.
ColistinDrug
Also called Colomycin
Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.
Carbapenem + Aminoglycoside/ QuinoloneDrug
Also called tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin
Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors
| Study group | Role | What they receive |
|---|---|---|
| Medication arm | Experimental | Colistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia Receives: Drug: Colistin |
| Control arm | Active comparator | Patients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function Receives: Drug: Carbapenem + Aminoglycoside/ Quinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Ventilatory status
Pf ratio measurement
Measured: 7 to 10 days
Secondary outcomes (4)
Days of mechanical ventilation
Deescalation in the ventilation mode and trials until successful weaning.
Measured: 35 Days
Time till the occurence of sepsis
long standing ventilator associated pneumonia with failure of treatment can lead to sepsis
Measured: 35 Days
Mortality as an outcome of long stand untreatable ventilator associated pneumonia
is the mortality due to sepsis of other causes
Measured: 35 days
Length of stay in the icu
How long will the patient stay in the ICU according to failure of weaning and progression of the disease.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start2 Jan 2016
- Primary completion6 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan Hassan Osama Thuraya Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Nourhan Hassan Osama Thuraya Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622450
- Sponsor's protocol ID
- Colistin inhalation form
- Status last verified
- Aug 2018
- First submitted
- 18 Jun 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Number of patients ,statistical data, method,discussion and outcome will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT03622450
- Acronym / sponsor ID
- Colistin inhalation form
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nourhan Hassan Osama Thuraya MohamedUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 6 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication arm | Experimental | Drug: ColistinColistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia |
| Control arm | Active comparator | Drug: Carbapenem + Aminoglycoside/ QuinolonePatients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years
- Patients presenting with signs of infection 48 hours of intubation
Key exclusion criteria (3 listed)
- Patients with documented bronchiectasis
- Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.
- Patients with creatinine clearance less than 30ml/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColistinAlso: ColomycinPolymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria. | Drug | Medication arm |
| Carbapenem + Aminoglycoside/ QuinoloneAlso: tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicinDual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors | Drug | Control arm |
Primary outcome
Assessment of Ventilatory status
Time frame: 7 to 10 days
Pf ratio measurement
4 secondary outcomes
Days of mechanical ventilation
Time frame: 35 Days
Time till the occurence of sepsis
Time frame: 35 Days
Mortality as an outcome of long stand untreatable ventilator associated pneumonia
Time frame: 35 days
Length of stay in the icu
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No. Number of patients ,statistical data, method,discussion and outcome will be shared
Related trials for Ventilator Associated Pneumonia
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colistin and Carbapenem + Aminoglycoside/ Quinolone in people with Ventilator Associated Pneumonia, run by Nourhan Hassan Osama Thuraya Mohamed.
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 2 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Assessment of Ventilatory status (time frame: 7 to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.