Nosocomial InfectionPhase 2NCT00438269
Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection
A Phase 2 study testing Site-specific empiric regimens included: Meropenem, Piperacillin/tazobactam and Ciprofloxacin and cefazolin +/- metronidazole in people with Nosocomial Infection and Pneumonia, run by Canadian Critical Care Trials Group at 1 site in Canada.
Trial summary
Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infection, Pneumonia, Systemic Inflammatory Response Syndrome
- What is being tested?
- Site-specific empiric regimens included: Meropenem, Piperacillin/tazobactam and Ciprofloxacin and cefazolin +/- metronidazole
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 2
- 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
- In hospital > 72 hrs and in ICU > 24hrs, and
- Core temperature ≥38.5°C, or temperature ≥ 38.0°C with a WBC>12,000/mm3, or temperature ≤ 36.0°C with a WBC > 12,000/mm3
- Suspicion of infection
Who cannot join
- Age < 18 years
- Imminent death (within 24 hrs) or withdrawal of aggressive therapy
- Prosthetic heart valve or vascular graft
- Neutropenia (Absolute neutrophil count < 1000/mm3)
- Received > 16 hours of a broad spectrum antibiotic in the last 24 hours (3rd gen cephalosporin, fluoroquinolone, carbapenem, anti-pseudomonal penicillin) or any combination therapy
- History of allergic reaction to both study medications
Show all 12Show fewer
- New physical findings consistent with infection:
- Meningeal signs
- Peritonitis + free air on Abdo x-ray
- Soft tissue infection / cellulitis
- Murmur \& suspicion of endocarditis
- Newly available (within past 24 hours) culture results consistent with infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appropriate Antimicrobial Therapy in Critical Care: A Pilot Randomized Controlled Trial
Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. It is unclear what the optimal management approach should be while awaiting the results of diagnostic tests. In some circumstances, broad spectrum antibiotics are started with a plan to adjust them once the results of cultures are available. Observational studies show that this results in greater antibiotic use, and the risk of superinfection and resistance. In other circumstances, antibiotics may be withheld pending the results of cultures, a strategy that leads to a delay in therapy when cultures are positive, and that may be associated with a worse clinical outcome.
We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?"
Recognizing that the question has not been formally addressed before, and that approaches to clinical management are both widely divergent and passionately held, our pilot study tested the feasibility and acceptability of undertaking a larger trial with sufficient power to determine equivalence.
Read the detailed description
We randomized critically ill patients who had been in hospital for at least 72 hours, and in the ICU for at least 24 hours, and who manifested either a temperature >38.5 degrees, or a temperature>38.0 degrees and a white cell count >12,000, and in whom clinicians entertained the possibility of infection as a diagnosis, to either site-specific broad spectrum empiric antibiotics or the corresponding placebo. All patients underwent a comprehensive series of investigations to identify an infectious focus, and all patients had full source control, including changes of central lines and urinary catheters, and change of nasogastric to orogastric tubes.
Patients were maintained in assigned study arm for seven days, or until culture data were available, at which time they were switched to culture-guided narrow spectrum therapy
- Conditions
- Nosocomial Infection, Pneumonia, Systemic Inflammatory Response Syndrome, Critical Illness, Pyrexia
- Being tested
- Site-specific empiric regimens included: Meropenem, Piperacillin/tazobactam, Ciprofloxacin and cefazolin +/- metronidazole
- Keywords
- Infection, Empiric, Antibiotics, Nosocomial, Pyrexia, Leukocytosis, Resistance
- Medical subject headings
- Cross Infection, Pneumonia, Systemic Inflammatory Response Syndrome, Critical Illness, Fever, Infections, Leukocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Site-specific empiric regimens included: MeropenemDrug
Piperacillin/tazobactamDrug
Ciprofloxacin and cefazolin +/- metronidazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: = % of eligible patients who were consented and randomized
Acceptability: = % of patients in each study arm who were switched to open label therapy prior to culture results
Secondary outcomes (5)
Mortality (14, 30, 90 day)
Microbial resistance patterns
ICU-free days
Antibiotic-free days
Change in organ dysfunction (MOD scores)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Canadian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Mary-Anne W Aarts, MD MSc, Principal investigator, University of TorontoJohn C Marshall, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438269
- Sponsor's protocol ID
- AATICC Pilot Study
- Status last verified
- Feb 2007
- First submitted
- 17 Feb 2007
- Last updated
- 22 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Antimicrobial Therapy in Critical Care: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00438269
- Acronym / sponsor ID
- AATICC Pilot Study
- Conditions
- Nosocomial Infection, Pneumonia, Systemic Inflammatory Response Syndrome, Critical Illness, Pyrexia
- Keywords
- Infection, Empiric, Antibiotics, Nosocomial, Pyrexia, Leukocytosis, Resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Canadian Critical Care Trials GroupUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Feb 2003
- Study completion
- Mar 2005
- First posted
- 22 Feb 2007 (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.
Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. It is unclear what the optimal management approach should be while awaiting the results of diagnostic tests. In some circumstances, broad spectrum antibiotics are started with a plan to adjust them once the results of cultures are available. Observational studies show that this results in greater antibiotic use, and the risk of superinfection and resistance. In other circumstances, antibiotics may be withheld pending the results of cultures, a strategy that leads to a delay in therapy when cultures are positive, and that may be associated with a worse clinical outcome.
We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?"
Recognizing that the question has not been formally addressed before, and that approaches to clinical management are both widely divergent and passionately held, our pilot study tested the feasibility and acceptability of undertaking a larger trial with sufficient power to determine equivalence.
Detailed description
We randomized critically ill patients who had been in hospital for at least 72 hours, and in the ICU for at least 24 hours, and who manifested either a temperature >38.5 degrees, or a temperature>38.0 degrees and a white cell count >12,000, and in whom clinicians entertained the possibility of infection as a diagnosis, to either site-specific broad spectrum empiric antibiotics or the corresponding placebo. All patients underwent a comprehensive series of investigations to identify an infectious focus, and all patients had full source control, including changes of central lines and urinary catheters, and change of nasogastric to orogastric tubes.
Patients were maintained in assigned study arm for seven days, or until culture data were available, at which time they were switched to culture-guided narrow spectrum therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In hospital > 72 hrs and in ICU > 24hrs, and
- Core temperature ≥38.5°C, or temperature ≥ 38.0°C with a WBC>12,000/mm3, or temperature ≤ 36.0°C with a WBC > 12,000/mm3
- Suspicion of infection
Key exclusion criteria (12 listed)
- Age < 18 years
- Imminent death (within 24 hrs) or withdrawal of aggressive therapy
- Prosthetic heart valve or vascular graft
- Neutropenia (Absolute neutrophil count < 1000/mm3)
- Received > 16 hours of a broad spectrum antibiotic in the last 24 hours (3rd gen cephalosporin, fluoroquinolone, carbapenem, anti-pseudomonal penicillin) or any combination therapy
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 |
|---|---|---|
| Site-specific empiric regimens included: Meropenem | Drug | – |
| Piperacillin/tazobactam | Drug | – |
| Ciprofloxacin and cefazolin +/- metronidazole | Drug | – |
Primary outcome
Feasibility: = % of eligible patients who were consented and randomized
Acceptability: = % of patients in each study arm who were switched to open label therapy prior to culture results
5 secondary outcomes
Mortality (14, 30, 90 day)
Microbial resistance patterns
ICU-free days
Antibiotic-free days
Change in organ dysfunction (MOD scores)
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 22 Feb 2007.
Related trials for Nosocomial Infection
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
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
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.
Mary-Anne W Aarts, MD MSc principal investigator
University of Toronto
John C Marshall, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Site-specific empiric regimens included: Meropenem, Piperacillin/tazobactam and Ciprofloxacin and cefazolin +/- metronidazole in people with Nosocomial Infection and Pneumonia, run by Canadian Critical Care Trials Group at 1 site in Canada.
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 12 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 22 Feb 2007. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Feasibility: = % of eligible patients who were consented and randomized. The study lists 2 primary outcomes in all. 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 22 Feb 2007.