Ventilator Associated PneumoniaPhase 4NAVPRONCT01118403
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
A Phase 4 study testing Sultamicillin in people with Ventilator Associated Pneumonia, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
Trial summary
This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. 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?
- Sultamicillin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2011to Mar 2011
- 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
- All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.
- Requiring mechanical ventilation for more than 48 hours
- Includes all patients with structural or metabolic coma
Who cannot join
- Pregnant women
- History of allergic reactions to ampicillin sulbactam
- Patients admitted as potential organ donors
- Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.
- Hospital stay for more than 48 hours before intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.
Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
Read the detailed description
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27%
Patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%.
These data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise.
Then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Sultamicillin
- Keywords
- Ventilator associated pneumonia, Coma, Brain Injuries, Intensive care units, antibiotic prophylaxis
- Medical subject headings
- Pneumonia, Ventilator-Associated, Coma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SultamicillinDrug
Also called Sulbactam Ampicillin, Unasyn
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution
| Study group | Role | What they receive |
|---|---|---|
| Sultamicillin, Antibiotic Prophylaxis | Experimental | Sultamicillin, Antibiotic Prophylaxis Receives: Drug: Sultamicillin |
| Placebo | Placebo comparator | Physiologic Sodium Chloride Solution Receives: Drug: Sultamicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia
To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours
Measured: 2 years
Secondary outcomes (1)
Effect of antibiotic prophylaxis versus placebo on the incidence of other infections
Compare the effect of antibiotic prophylaxis versus placebo on the incidence of later ventilator-associated pneumonia, as well as in other non-pulmonary infections (catheter sepsis, bacteremia, meningitis, urinary tract infection).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: He could not be started due to lack of funds
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos A Cadavid, MD, Principal investigator, Hospital Pablo Tobón Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118403
- Sponsor's protocol ID
- 58222
- Acronym
- NAVPRO
- Status last verified
- May 2016
- First submitted
- 4 May 2010
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01118403
- Acronym / sponsor ID
- NAVPRO / 58222
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator associated pneumonia, Coma, Brain Injuries, Intensive care units, antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: He could not be started due to lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Pablo Tobón UribeUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 May 2010 (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.
This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.
Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
Detailed description
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27%
Patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%.
These data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise.
Then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sultamicillin, Antibiotic Prophylaxis | Experimental | Drug: SultamicillinSultamicillin, Antibiotic Prophylaxis |
| Placebo | Placebo comparator | Drug: SultamicillinPhysiologic Sodium Chloride Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.
- Requiring mechanical ventilation for more than 48 hours
- Includes all patients with structural or metabolic coma
Key exclusion criteria (5 listed)
- Pregnant women
- History of allergic reactions to ampicillin sulbactam
- Patients admitted as potential organ donors
- Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.
- Hospital stay for more than 48 hours before intubation.
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 |
|---|---|---|
| SultamicillinAlso: Sulbactam Ampicillin, UnasynAmpoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution | Drug | Placebo, Sultamicillin, Antibiotic Prophylaxis |
Primary outcome
Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia
Time frame: 2 years
To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours
1 secondary outcome
Effect of antibiotic prophylaxis versus placebo on the incidence of other infections
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: No
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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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.
Carlos A Cadavid, MD principal investigator
Hospital Pablo Tobón Uribe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sultamicillin in people with Ventilator Associated Pneumonia, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
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 5 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: withdrawn, as of the sponsor's last update on 24 May 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 Colombia. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia (time frame: 2 years). 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 24 May 2016.