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Recent CTTI Publication Investigates HABP/VABP Risk and Antibiotic Trial Eligibility for Hospitalized Patients in Europe

Posted on by Hannah Faulkner

Topics Included: Safety

A new CTTI publication investigates the prospective identification of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) risk factors and antibiotic trial eligibility among hospitalized, critically ill patients at seven European hospitals. The study, PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts, published in Open Forum Infectious Diseases, evaluated 888 critically ill patients receiving ventilation or high levels of supportive oxygen and used existing clinical criteria to predict which patients would develop HABP/VABP. The researchers compared these results to those of a prior CTTI study of U.S. patients, finding that a higher proportion of European patients who were treated for possible HABP/VABP met the pneumonia definition compared to their counterparts in U.S. hospitals. The European patients were also more likely to meet common antibiotic trial eligibility criteria. The results could be applied to the development of new strategies to improve registrational trial feasibility and foster the development of much needed new antibacterial treatments for HABP/VABP. 

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CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Posted on by Hannah Faulkner

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard clinical definitions of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). A new CTTI paper available online in CHEST® Journal, accompanied by an insightful editorial, “Heeding the Prophetic Call,” outlines how the use of simple clinical criteria may help to identify high-risk patients earlier and aid future research to improve prevention and treatment.

 

The paper highlights the Prospective Identification of Pneumonia in Hospitalized Patients in the ICU (PROPHETIC) study, a large, contemporary, prospective cohort clinical trial designed by CTTI that made several key observations.

 

“HABP/VABP is associated with high mortality and morbidity and may be caused by multidrug-resistant pathogens,” said John Farley, director of the Office of Infectious Diseases at the FDA.   “Conducting clinical trials in HABP/VABP is challenging, and data to understand the patient population is critical to improve trial feasibility.”

The study sought to define the incidence of HABP/VABP in an ICU population and identify characteristics associated with the development of HABP/VABP to inform the design and conduct of future clinical trials.

The study determined that 32 percent of 4,613 prospectively identified high-risk patients received antibiotics for possible HABP/VABP. It was also determined that only 12 percent of the aforementioned high-risk patients fit the FDA Guidance standard clinical definition of HABP/VABP.

“These findings indicate that the burden of HABP and VABP is significant and there is also some concern about antibiotic overprescription in this high-risk population,” said Vance Fowler, professor of medicine at Duke University. “Receiving antibiotics is itself a risk factor for developing pneumonia, carries risks of adverse events, and may preclude eligibility for HABP/VABP clinical trial enrollment.”

Additionally, the manuscript highlights the common characteristics and treatment exposures researchers identified that were associated with increased odds of developing HABP/VABP in high-risk patients.

“Application of the study results to prospectively identify patients at highest risk for HABP/VABP may help to facilitate the conduct of innovative and efficient clinical trials,” said Pamela Tenaerts, executive director of CTTI. “This will help to promote development of optimal preventive, diagnostic, and treatment strategies to improve management of this disease.”

Learn more about CTTI’s work on HABP/VABP Studies.

New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies

Posted on by Hannah Faulkner

A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of gathering feedback from 52 stakeholders to identify the most important elements to include in the informed consent process.

Previous CTTI research suggested that an early enrollment strategy using advance consent in pneumonia antibiotic trials is acceptable to key stakeholders. As part of that research, CTTI also engaged these stakeholders to identify, describe, and reach consensus on essential concepts that should be included in an advance consent form for a HABP/VABP clinical trial. Concepts were:

  • Reassurances on patient health and treatment
  • Reasons for advance consent and enrolling early
  • Explanation of non-inferiority

The proposed consent language developed in this process, in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset, may help potential participants make informed decisions about their involvement in clinical research. It may also improve enrollment rates in trials from which data are urgently needed to evaluate new treatments and improve patient care.

Learn more about past CTTI work on HABP/VABP.

New CTTI Paper Outlines Risk Factors to Aid in HABP/VABP Pediatric Trial Enrollment

Posted on by Hannah Faulkner

A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

These risk factors are important because they could aid in earlier and more accurate diagnosis of HABP/VABP, alleviating roadblocks to enrollment in HABP/VABP clinical trials. Improved enrollment could help speed the development of new antibiotics for HABP/VABP, which can often be deadly for children.

The paper details a study conducted by the Pediatric Trials Network in collaboration CTTI, which used pediatric patients’ electronic health records to identify which patients received qualifying respiratory support or antibiotics for either a lower respiratory infection or undifferentiated sepsis. The study then followed the selected patients until they were either diagnosed with HABP/VABP or discharged from the intensive care unit.

Of 862 newborns, infants, and children younger than 18 who were evaluated, 10 percent of patients receiving respiratory support and 12 percent overall developed HABP/VABP. While risk factors varied by age group, patients showed increased odds of developing HABP/VABP if they:

  • Were older
  • Were shorter
  • Spent a longer time in the intensive care unit
  • Were at risk of aspiration
  • Had received a blood product transfusion in the prior seven days
  • Had frequent suctioning

Increased attention to patients with these high-risk features could lead to improved identification of eligible participants in HABP/VABP antibiotic trials.

Learn more about CTTI’s work to improve the feasibility of HABP/VABP clinical trials.