Ventilator-associated PneumoniaPhase 3COLIVAPNCT02906722
Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia
A Phase 3 study testing Intravenous colimycin and Nebulized colimycin in people with Ventilator-associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. 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?
- Intravenous colimycin and Nebulized colimycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2017to 19 Jun 2018
- Phase
- Phase 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 older than 18 yr
- Invasive mechanical ventilation for more than 48 h Tracheostomized patients receiving intermittent mechanical ventilation can be included
- VAP caused by Gram-negative MDR bacteria resistant to all β-lactams and fluoroquinolones
Who cannot join
- Extrapulmonary Gram-negative MDR infection requiring intravenous colimycin
- VAP associated with bacteremia requiring combined treatment by nebulized and intravenous colimycin
- Hypersensitivity to colistimethate, colistin base, polymyxins and/or their excipients
- Porphyria
- Severe hypoxemia defined as PaO2 / FiO2< 100; if veno-venous ECMO is initiated, the patient can be included
- Severe brain injury (initial Glasgow coma score < 8) during the first 7 days before randomization
Show all 13Show fewer
- Myasthenia
- cystic fibrosis
- Refusal to participate in the study
- Participation in any clinical study of a therapeutic investigational product within 30 days prior to the first day of inclusion
- No affiliation to social health insurance
- Patient under guardianship
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Nebulized Versus Intravenous Colimycin for Treating Ventilator-associated Pneumonia Caused by Gram-negative Multidrug-resistant Bacteria: a Prospective, Multicenter, Randomized and Double-blind Study
Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.
Read the detailed description
VAP is the most frequent nosocomial infection in critically ill patients and affects length of stay and cost in Intensive Care Unit. The increased incidence of nosocomial infections caused by MDR bacteria becomes a major health problem worldwide.
Nowadays, few antimicrobials are available to treat Gram negative MDR VAP. Colimycin often remains the only active antibiotic. Treating VAP by intravenous (IV) colimycin has two main limitations: risk of renal toxicity and low tissue penetration. Nebulization of colimycin offers the possibility of generating high lung tissue concentrations, rapid bactericidal effects and low systemic accumulation in experimental models. To date however, there is no study comparing clinical effectiveness of nebulized and intravenous colimycin.
We make the hypothesis that nebulized colimycin increases the clinical cure rate of VAP caused by Gram negative MDR bacteria compared to IV colimycin.
Primary Objective: To demonstrate the superiority of nebulized colimycin over intravenous colimycin for treating VAP caused by Gram-negative MDR bacteria.
Secondary Objectives:
- To compare the microbiological cure rate at end of treatment
- To compare the VAP recurrence rate after end of treatment
- To compare the lung superinfection rate after end of treatment
- To compare 28 day- and 90 day-mortality
- To compare duration of mechanical ventilation
- To compare length of ICU stay
- To compare renal function during colimycin administration
- To compare side effects resulting from colimycin nebulization and intravenous administration
Ancillary study:
In some centers, blood samples will be performed to measure colistin peak and trough plasma concentrations
Study design:
This is a randomized, multicenter, double-blind and phase III study
- Randomization: Patients are randomly assigned to experimental group or control group: Control group: patients receive simultaneously intravenous colimycin and nebulized placebo. Experimental group: patients receive simultaneously nebulized colimycin and intravenous infusion of placebo. Dosing adjustment is according to renal function for intravenous infusion of colimycin or placebo.
- Aerosol generation: Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) with following ventilator settings:
- Constant flow and volume-controlled mode
- Inspiratory/expiratory ratio of 1
- Tidal volume of 6-8 ml/kg
- Respiratory frequency of 12-18/min
- End-inspiratory pause of 20% To standardize nebulization procedure, a checklist form is completed by the nurse in charge of the patient.
- Duration of treatment:
- 10 days in each group
- In intubated patients, weaning test is authorized after 4 days of treatment. If patient is extubated, aerosols are discontinued whereas intravenous infusions are continued (placebo or antibiotic) until day 10
- In tracheostomized patients: 10-day treatment for nebulized and intravenous therapy
- Combined intravenous administration of other antimicrobials are authorized
- Serum and microbiological samples
- Serum creatinine measured daily from baseline to day 11
- Lower respiratory tract specimens at day 5 and day 11 in intubated patients
- Survival follow-up at day 28 and 90 days
Study population: Adult mechanical ventilated patients with VAP caused by Gram-negative MDR bacteria.
Sample size and Power consideration: Data will be analyzed with triangular test. Assuming a clinical cure rate at day 11 of 65% in the group treated with nebulized colimycin and of 45% in the group treated with intravenous colimycin, a mean sample size of 134 patients is required to provide 80% power, with a two-sided type I error rate of 5%. The 90th percentile of the number of patients to include is 196.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Intravenous colimycin, Intravenous placebo, Nebulized colimycin, Nebulized placebo
- Keywords
- Nebulized colistin, Intravenous colistin, ventilator-associated pneumonia, multidrug resistance, Gram-negative bacteria
- 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.
Intravenous colimycinDrug
administration once, twice or 3 times per day according to renal function
Intravenous placeboDrug
administration once, twice or 3 times per day according to renal function
Nebulized colimycinDrug
Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h
Nebulized placeboDrug
Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients receive simultaneously nebulized colimycin every 8 h and intravenous placebo administered once, twice or 3 times per day according to renal function Receives: Drug: Intravenous placebo; Drug: Nebulized colimycin |
| Control group | Active comparator | Patients receive simultaneously intravenous colimycin administered once, twice or 3 times per day according to function renal and nebulized placebo every 8 h Receives: Drug: Intravenous colimycin; Drug: Nebulized placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria
Clinical cure is defined as:
- resolution of clinical and biological signs of infection and improved radiological signs
- and modified clinical pulmonary infection score (CPIS) less than 6
- and negative culture of lower respiratory tract specimen or, successful weaning from invasive mechanical ventilation between day 5 and day 11
- patient colonized with the same pathogen in the respiratory tract is considered as cured, if clinical and biological signs of infection resolved, radiological signs improved, CPIS < 6 and/or successful weaning from invasive mechanical ventilation has been obtained.
Measured: At end of therapy visit (day11) or before day11 if treatment is considered as failed.
Secondary outcomes (9)
Microbiological cure rate
Measured: At end of therapy visit (day11) or before day11 if treatment is considered as failed.
VAP recurrence rate
VAP recurrence rate, defined as initial clinical cure of VAP with colimycin at day 11 followed by reappearance of clinical and biological signs of infection, CPIS greater than 6, and significant concentrations of Gram-negative MDR bacteria in lower respiratory tract specimen
Measured: day 28
Lung superinfection rate
Lung superinfection rate defined as reappearance of VAP caused by pathogens other than Gram-negative MDR bacteria isolated from lower respi¬ratory tract specimens from day 11 to day 28
Measured: day 11, day 28
Mortality
Measured: day 28 and day 90
Duration of mechanical ventilation
Measured: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Length of ICU stay
Measured: Participants will be followed for the duration of ICU stay, an expected average of 2 months
Renal function during colimycin administration
Renal function is assessed by measuring daily serum creatinine during treatment period. Colimycin-induced renal function impairment is defined as an increase in serum creatinine level more than 1.5 times the pretreatment value
Measured: from Day 1 to Day 11
Side effects resulting from colimycin nebulization
Measured: from Day 1 to Day 11
Side effects resulting from colimycin intravenous administration
Measured: from Day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start31 Jul 2017
- Primary completion27 Mar 2018
- Study completion19 Jun 2018
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin LU, MD, PhD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906722
- Sponsor's protocol ID
- P130902
- Other IDs
- 2016-000389-41, 2016
- Acronym
- COLIVAP
- Status last verified
- Nov 2017
- First submitted
- 12 Aug 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sole-Lleonart C, Rouby JJ, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Roberts JA, Rello J. Intratracheal Administration of Antimicrobial Agents in Mechanically Ventilated Adults: An International Survey on Delivery Practices and Safety. Respir Care. 2016 Aug;61(8):1008-14. doi: 10.4187/respcare.04519. Epub 2016 Mar 8.
PubMed 26957647Sole-Lleonart C, Rouby JJ, Blot S, Poulakou G, Chastre J, Palmer LB, Bassetti M, Luyt CE, Pereira JM, Riera J, Felton T, Dhanani J, Welte T, Garcia-Alamino JM, Roberts JA, Rello J. Nebulization of Antiinfective Agents in Invasively Mechanically Ventilated Adults: A Systematic Review and Meta-analysis. Anesthesiology. 2017 May;126(5):890-908. doi: 10.1097/ALN.0000000000001570.
PubMed 28248714Rello J, Rouby JJ, Sole-Lleonart C, Chastre J, Blot S, Luyt CE, Riera J, Vos MC, Monsel A, Dhanani J, Roberts JA. Key considerations on nebulization of antimicrobial agents to mechanically ventilated patients. Clin Microbiol Infect. 2017 Sep;23(9):640-646. doi: 10.1016/j.cmi.2017.03.018. Epub 2017 Mar 25.
PubMed 28347790Sole-Lleonart C, Roberts JA, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Qiu H, Rouby JJ, Rello J; ESGCIP Investigators. Global survey on nebulization of antimicrobial agents in mechanically ventilated patients: a call for international guidelines. Clin Microbiol Infect. 2016 Apr;22(4):359-364. doi: 10.1016/j.cmi.2015.12.016. Epub 2015 Dec 23.
PubMed 26723563
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized Versus Intravenous Colimycin for Treating Ventilator-associated Pneumonia Caused by Gram-negative Multidrug-resistant Bacteria: a Prospective, Multicenter, Randomized and Double-blind Study
- ClinicalTrials.gov ID
- NCT02906722
- Acronym / sponsor ID
- COLIVAP / P130902
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- Nebulized colistin, Intravenous colistin, ventilator-associated pneumonia, multidrug resistance, Gram-negative bacteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.
Detailed description
VAP is the most frequent nosocomial infection in critically ill patients and affects length of stay and cost in Intensive Care Unit. The increased incidence of nosocomial infections caused by MDR bacteria becomes a major health problem worldwide.
Nowadays, few antimicrobials are available to treat Gram negative MDR VAP. Colimycin often remains the only active antibiotic. Treating VAP by intravenous (IV) colimycin has two main limitations: risk of renal toxicity and low tissue penetration. Nebulization of colimycin offers the possibility of generating high lung tissue concentrations, rapid bactericidal effects and low systemic accumulation in experimental models. To date however, there is no study comparing clinical effectiveness of nebulized and intravenous colimycin.
We make the hypothesis that nebulized colimycin increases the clinical cure rate of VAP caused by Gram negative MDR bacteria compared to IV colimycin.
Primary Objective: To demonstrate the superiority of nebulized colimycin over intravenous colimycin for treating VAP caused by Gram-negative MDR bacteria.
Secondary Objectives:
- To compare the microbiological cure rate at end of treatment
- To compare the VAP recurrence rate after end of treatment
- To compare the lung superinfection rate after end of treatment
- To compare 28 day- and 90 day-mortality
- To compare duration of mechanical ventilation
- To compare length of ICU stay
- To compare renal function during colimycin administration
- To compare side effects resulting from colimycin nebulization and intravenous administration
Ancillary study:
In some centers, blood samples will be performed to measure colistin peak and trough plasma concentrations
Study design:
This is a randomized, multicenter, double-blind and phase III study
- Randomization: Patients are randomly assigned to experimental group or control group: Control group: patients receive simultaneously intravenous colimycin and nebulized placebo. Experimental group: patients receive simultaneously nebulized colimycin and intravenous infusion of placebo. Dosing adjustment is according to renal function for intravenous infusion of colimycin or placebo.
- Aerosol generation: Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) with following ventilator settings:
- Constant flow and volume-controlled mode
- Inspiratory/expiratory ratio of 1
- Tidal volume of 6-8 ml/kg
- Respiratory frequency of 12-18/min
- End-inspiratory pause of 20% To standardize nebulization procedure, a checklist form is completed by the nurse in charge of the patient.
- Duration of treatment:
- 10 days in each group
- In intubated patients, weaning test is authorized after 4 days of treatment. If patient is extubated, aerosols are discontinued whereas intravenous infusions are continued (placebo or antibiotic) until day 10
- In tracheostomized patients: 10-day treatment for nebulized and intravenous therapy
- Combined intravenous administration of other antimicrobials are authorized
- Serum and microbiological samples
- Serum creatinine measured daily from baseline to day 11
- Lower respiratory tract specimens at day 5 and day 11 in intubated patients
- Survival follow-up at day 28 and 90 days
Study population: Adult mechanical ventilated patients with VAP caused by Gram-negative MDR bacteria.
Sample size and Power consideration: Data will be analyzed with triangular test. Assuming a clinical cure rate at day 11 of 65% in the group treated with nebulized colimycin and of 45% in the group treated with intravenous colimycin, a mean sample size of 134 patients is required to provide 80% power, with a two-sided type I error rate of 5%. The 90th percentile of the number of patients to include is 196.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Intravenous placebo, Drug: Nebulized colimycinPatients receive simultaneously nebulized colimycin every 8 h and intravenous placebo administered once, twice or 3 times per day according to renal function |
| Control group | Active comparator | Drug: Intravenous colimycin, Drug: Nebulized placeboPatients receive simultaneously intravenous colimycin administered once, twice or 3 times per day according to function renal and nebulized placebo every 8 h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 yr
- Invasive mechanical ventilation for more than 48 h Tracheostomized patients receiving intermittent mechanical ventilation can be included
- VAP caused by Gram-negative MDR bacteria resistant to all β-lactams and fluoroquinolones
Key exclusion criteria (13 listed)
- Extrapulmonary Gram-negative MDR infection requiring intravenous colimycin
- VAP associated with bacteremia requiring combined treatment by nebulized and intravenous colimycin
- Hypersensitivity to colistimethate, colistin base, polymyxins and/or their excipients
- Porphyria
- Severe hypoxemia defined as PaO2 / FiO2< 100; if veno-venous ECMO is initiated, the patient can be included
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 |
|---|---|---|
| Intravenous colimycinadministration once, twice or 3 times per day according to renal function | Drug | Control group |
| Intravenous placeboadministration once, twice or 3 times per day according to renal function | Drug | Experimental group |
| Nebulized colimycinNebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h | Drug | Experimental group |
| Nebulized placeboNebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h | Drug | Control group |
Primary outcome
Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria
Time frame: At end of therapy visit (day11) or before day11 if treatment is considered as failed.
Clinical cure is defined as: * resolution of clinical and biological signs of infection and improved radiological signs * and modified clinical pulmonary infection score (CPIS) less than 6 * and negative culture of lower respiratory tract specimen or, successful weaning from invasive mechanical ventilation between day 5 and day 11 * patient colonized with the same pathogen in the respiratory tract is considered as cured, if clinical and biological signs of infection resolved, radiological signs improved, CPIS < 6 and/or successful weaning from invasive mechanical ventilation has been obtained.
9 secondary outcomes
Microbiological cure rate
Time frame: At end of therapy visit (day11) or before day11 if treatment is considered as failed.
VAP recurrence rate
Time frame: day 28
Lung superinfection rate
Time frame: day 11, day 28
Mortality
Time frame: day 28 and day 90
Duration of mechanical ventilation
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 3 weeks
Length of ICU stay
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 months
Renal function during colimycin administration
Time frame: from Day 1 to Day 11
Side effects resulting from colimycin nebulization
Time frame: from Day 1 to Day 11
Side effects resulting from colimycin intravenous administration
Time frame: from Day 1 to day 28
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Background: PubMed 26957647Sole-Lleonart C, Rouby JJ, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Roberts JA, Rello J. Intratracheal Administration of Antimicrobial Agents in Mechanically Ventilated Adults: An International Survey on Delivery Practices and Safety. Respir Care. 2016 Aug;61(8):1008-14. doi: 10.4187/respcare.04519. Epub 2016 Mar 8.
- Background: PubMed 28248714Sole-Lleonart C, Rouby JJ, Blot S, Poulakou G, Chastre J, Palmer LB, Bassetti M, Luyt CE, Pereira JM, Riera J, Felton T, Dhanani J, Welte T, Garcia-Alamino JM, Roberts JA, Rello J. Nebulization of Antiinfective Agents in Invasively Mechanically Ventilated Adults: A Systematic Review and Meta-analysis. Anesthesiology. 2017 May;126(5):890-908. doi: 10.1097/ALN.0000000000001570.
- Background: PubMed 28347790Rello J, Rouby JJ, Sole-Lleonart C, Chastre J, Blot S, Luyt CE, Riera J, Vos MC, Monsel A, Dhanani J, Roberts JA. Key considerations on nebulization of antimicrobial agents to mechanically ventilated patients. Clin Microbiol Infect. 2017 Sep;23(9):640-646. doi: 10.1016/j.cmi.2017.03.018. Epub 2017 Mar 25.
- Background: PubMed 26723563Sole-Lleonart C, Roberts JA, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Qiu H, Rouby JJ, Rello J; ESGCIP Investigators. Global survey on nebulization of antimicrobial agents in mechanically ventilated patients: a call for international guidelines. Clin Microbiol Infect. 2016 Apr;22(4):359-364. doi: 10.1016/j.cmi.2015.12.016. Epub 2015 Dec 23.
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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.
Qin LU, MD, PhD principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous colimycin and Nebulized colimycin in people with Ventilator-associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 13 Aug 2018. 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 France. 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 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 was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
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?
Clinical cure of VAP caused by Gram-negative multidrug resistant bacteria (time frame: At end of therapy visit (day11) or before day11 if treatment is considered as failed.). 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 NCT02906722, which also lists 4 linked publications.
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 13 Aug 2018.