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Mount Sinai Hospital Critical Care Research - Current Studies
AATICC Study
(Appropriate Antimicrobial Therapy In Critical Care Study)
A Randomized Double-Blind Placebo Controlled Trial of Broad-Spectrum Empiric Antibiotic Therapy Versus Delayed Narrow-Spectrum Infection Directed Therapy in Critically Ill Patients With Suspected Nosocomial Infection
A multicentric CIHR funded study. P.I. Dr. Mary-Anne Aarts & Dr. John Marshall
Site Investigator: Dr. Stephen Lapinsky
Site Co-ordinator: Carlos Martinez
Empiric antibiotic therapy is a widely used, but unproven practice in contemporary intensive care units. The perceived need for pre-emptive antibiotic therapy stems from factors unique to infection in the critically ill. Nosocomial infection is common, occurring in up to one third of all patients admitted to an ICU. The diagnosis is challenging. Clinical manifestations are non-specific, culture data are unreliable because of concomitant antibiotic use, and the differentiation of colonization from invasive infection is notoriously difficult. Infecting organisms are commonly resistant to first line antibiotics. Infecting organisms are commonly resistant to first-line antibiotics. ICU-acquired infections develop in the sickest patients, for whom maximal therapeutic intervention is the norm, and clinicians are frequently reluctant to stop therapy, even when cultures are negative. On the other hand, indiscriminate use of broad-spectrum coverage is associated with the emergence of multi-resistant organisms, an increased rate of superinfections in exposed patients, and substantial cost for the health care system. Individual clinicians vary in their approach to the indications for empiric therapy, and attitudes, though divergent, are strongly held. Although the benefits of antibiotics as specific anti-infective therapy for community-acquired infection are well accepted, those of empiric broad-spectrum coverage for suspected nosocomial infection in the ICU are not, and available research does not permit firm conclusions about whether such empiric therapy helps, harms, or yields no net benefit.
The research question for the AATICC trial is: In patients with a suspected nosocomial ICU-acquired infection, does early broad-spectrum empiric antibiotic therapy improve survival when compared to delayed narrow spectrum, culture-directed antibiotic therapy?
The study’s hypothesis is that withholding of broad-spectrum antibiotic therapy is safe, and a strategy of narrow spectrum culture-directed therapy will decrease the subsequent development of superinfections, infections with resistant organisms, and death.
The AATICC trial is a randomized double-blind placebo-controlled pilot trial. The intervention in this trial is to randomize patients in whom the suspicion of a new infection arises after being in the ICU for > 72 hours, to receive broad-spectrum antibiotic vs. placebo. Study drug is continued until there is objective evidence of infection (via cultures, radiology or surgery) to a maximum of seven days. If the study drug is stopped within the 7 days study period no other empiric antibiotic can be started.
If you require further information please contact Carlos Martinez at CMartinez@mtsinai.on.ca
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