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Sponsors and Collaborators: |
Canadian Critical Care Trials Group The Physicians' Services Incorporated Foundation |
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Information provided by: | Canadian Critical Care Trials Group |
ClinicalTrials.gov Identifier: | NCT00438269 |
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.
Condition | Intervention | Phase |
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Nosocomial Infection Pneumonia Systemic Inflammatory Response Syndrome Critical Illness Pyrexia |
Drug: Site-specific empiric regimens included: Meropenem Drug: Piperacillin/tazobactam Drug: Ciprofloxacin and cefazolin +/- metronidazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Appropriate Antimicrobial Therapy in Critical Care: A Pilot Randomized Controlled Trial |
Estimated Enrollment: | 80 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | March 2005 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
New physical findings consistent with infection:
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Mary-Anne W Aarts, MD MSc | University of Toronto |
Principal Investigator: | John C Marshall, MD | University of Toronto |
Study ID Numbers: | AATICC Pilot Study |
Study First Received: | February 17, 2007 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00438269 History of Changes |
Health Authority: | Canada: Health Canada |
Infection Empiric Antibiotics Nosocomial |
Pyrexia Leukocytosis Resistance |
Systemic Inflammatory Response Syndrome Anti-Infective Agents Metronidazole Tazobactam Piperacillin-tazobactam combination product Inflammation Fever Ciprofloxacin Anti-Bacterial Agents Cefazolin Radiation-Sensitizing Agents |
Penicillanic Acid Respiratory Tract Diseases Respiratory Tract Infections Shock Critical Illness Lung Diseases Meropenem Piperacillin Pneumonia Cross Infection |
Communicable Diseases Metronidazole Anti-Infective Agents Antiprotozoal Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Piperacillin-tazobactam combination product Infection Anti-Bacterial Agents Ciprofloxacin Antiparasitic Agents Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases |
Syndrome Therapeutic Uses Nucleic Acid Synthesis Inhibitors Cross Infection Systemic Inflammatory Response Syndrome Disease Enzyme Inhibitors Tazobactam Pharmacologic Actions Inflammation Radiation-Sensitizing Agents Shock Penicillanic Acid Critical Illness Lung Diseases |