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Inpatient Intensive Care Studies

Not yet enrolling:

Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Estimate the rates of HABP/VABP diagnosis in ICU patients considered high risk for pneumonia. High risk is defined by treatment with one or more of the following respiratory modalities for at least 12 hours, currently or within the prior 7 days:

  1. Invasive mechanical ventilation
  2. Noninvasive ventilation (bilevel positive airway pressure [BiPAP] or continuous positive airway pressure [CPAP] for any indication other than obstructive sleep apnea)

iii. High-flow, supplemental oxygen therapy via nasal cannula. Only include systems using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM.

  1. High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol facemask or tracheostomy collar (mask). Only include systems using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM.
  2. Supplemental oxygen therapy delivered via either partial or non-rebreather face mask

Estimate the proportion of patients diagnosed with HABP/VABP who would be eligible for enrollment in a clinical trial of antibacterial therapy for HABP/VABP per FDA draft guidance document criteria.

  1. Diagnosed is defined as fulfilling study HABP/VABP diagnostic criteria.
  2. Eligible for enrollment will be defined as: Subject fulfills study HABP/VABP diagnostic criteria, and the time at which these diagnostic criteria were met is less than 24 hours after the first dose of antibiotics for HABP/VABP

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02689531?term=CTTI&rank=1

If you are interested in participating in this study or would like more information, please contact Brooks Morgan, RN at (352) 273-5870.

Closed:

VAP: Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance during the Treatment of Hospitalized Subjects with Pneumonia Requiring Mechanical Ventilation

Hospitalized male and female patients ≥ 18 years with culture-documented hospital-acquired bacterial pneumonia (HABP), or health-care associated pneumonia (HCAP) requiring mechanical ventilation or ventilator-associated bacterial pneumonia (VABP) will be enrolled. Therefore, subjects will include those in any health care facility who develop pneumonia 48 or more hours after admission and those in a nursing home or rehabilitation center who develop pneumonia and are transferred to an acute care facility.

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01570192?term=NCT01570192&rank=1

If you would like more information, please contact Brooks Morgan, RN at (352) 273-5870.

Closed:

A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered via the Investigational eFlow® Inline System in Mechanically Ventilated Patients with Gram-negative Bacterial Pneumonia (IASIS)

The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS) delivered by the aerosol to the lungs via the Investigational eFlow Inline system. Inclusion criteria include male and female patients ≥18 years old who have a diagnosis of pneumonia requiring mechanical ventilation.

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01969799?term=iasis&rank=1

If you would like more information, please contact Brooks Morgan, RN at (352) 273-5870.

Closed:

Genentech Blue: A Phase 2 Randomized, Double-Blind Placebo-Controlled Trial Of MHAA4549A, A Monoclonal Antibody, In Combination With Oseltamivir Versus Oseltamivir For Treatment Of Severe Influenza A Infection

The purpose of this study is to evaluate MHAA4549A, a monoclonal antibody, versus placebo in patients with severe Influenza A Infection on background therapy with Oseltamivir. Inclusion criteria include male and female patients ≥18 years old who have a diagnosis of Influenza A and are severely ill, requiring oxygen to support their blood oxygen level.

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link:

If you would like more information, please contact Brooks Morgan, RN at (352) 273-5870.

Closed:

Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia (TCAP)

The primary purpose is to assess the efficacy and safety of 90 days of oral ticagrelor in patients hospitalized with severe community acquired pneumonia (CAP).

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link:

http://clinicaltrials.gov/ct2/show/NCT01998399?term=Randomized+Trial+of+Ticagrelor+for+Severe+Community+Acquired+Pneumonia+%28TCAP%29&rank=1

If you would like more information, please contact Brooks Morgan, RN at (352) 273-5870.

Closed:

AF541Single Use Oro-nasal Masks Clinical Evaluation

The AF541 Oro-nasal masks provide an interface for application of Noninvasive Positive Pressure Ventilation (NPPV). The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems and which are intended to administer NPPV or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The masks are single use devices.  They are to be used only on adult patients (>20kg) who are appropriate candidates for noninvasive ventilation in the hospital/institutional clinical environment.

Principal Investigator: Hassan Alnuaimat, MD

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02383719?term=convergent+engineering&rank=1

If you would like more information, please contact Brooks Morgan, RN at (352) 273-5870.