Aspiration Clinical Trial
Official title:
Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
Verified date | November 2023 |
Source | UConn Health |
Contact | Brandon Oto, PA-C |
Phone | 860-679-3107 |
oto[@]uchc.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU - Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris) - Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event). Exclusion Criteria: - Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment - Requires antibiotic therapy for the treatment of other infections - Patient "comfort measures only" at time of screening - Currently participating in other trials using investigational drugs or interventions - Currently pregnant - Currently a prisoner - The consenting party (patient or their legally authorized representative) is unable to understand or read English at a fifth-grade level. - 2 or more of the following are present at the time of screening: - White blood cell count: = 11.0 - Temperature = 38.0C (100.4F) - Purulent secretions - S/F (pulse oximetry saturation to FiO2) ratio = 215 |
Country | Name | City | State |
---|---|---|---|
United States | UConn Health, John Dempsey Hospital | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
UConn Health |
United States,
Acquarolo A, Urli T, Perone G, Giannotti C, Candiani A, Latronico N. Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study. Intensive Care Med. 2005 Apr;31(4):510-6. doi: 10.1007/s00134-005-2585-5. Epub 2005 Mar 8. — View Citation
DiBardino DM, Wunderink RG. Aspiration pneumonia: a review of modern trends. J Crit Care. 2015 Feb;30(1):40-8. doi: 10.1016/j.jcrc.2014.07.011. Epub 2014 Jul 22. — View Citation
Dragan V, Wei Y, Elligsen M, Kiss A, Walker SAN, Leis JA. Prophylactic Antimicrobial Therapy for Acute Aspiration Pneumonitis. Clin Infect Dis. 2018 Aug 1;67(4):513-518. doi: 10.1093/cid/ciy120. — View Citation
El-Solh AA, Pietrantoni C, Bhat A, Aquilina AT, Okada M, Grover V, Gifford N. Microbiology of severe aspiration pneumonia in institutionalized elderly. Am J Respir Crit Care Med. 2003 Jun 15;167(12):1650-4. doi: 10.1164/rccm.200212-1543OC. Epub 2003 Apr 10. — View Citation
Francois B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefeve G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379. — View Citation
Lascarrou JB, Lissonde F, Le Thuaut A, Bachoumas K, Colin G, Henry Lagarrigue M, Vinatier I, Fiancette M, Lacherade JC, Yehia A, Joret A, Lebert C, Bourdon S, Martin Lefevre L, Reignier J. Antibiotic Therapy in Comatose Mechanically Ventilated Patients Following Aspiration: Differentiating Pneumonia From Pneumonitis. Crit Care Med. 2017 Aug;45(8):1268-1275. doi: 10.1097/CCM.0000000000002525. — View Citation
Marik PE, Careau P. The role of anaerobes in patients with ventilator-associated pneumonia and aspiration pneumonia: a prospective study. Chest. 1999 Jan;115(1):178-83. doi: 10.1378/chest.115.1.178. — View Citation
Marik PE. Aspiration syndromes: aspiration pneumonia and pneumonitis. Hosp Pract (1995). 2010 Feb;38(1):35-42. doi: 10.3810/hp.2010.02.276. — View Citation
Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST. — View Citation
Rebuck JA, Rasmussen JR, Olsen KM. Clinical aspiration-related practice patterns in the intensive care unit: a physician survey. Crit Care Med. 2001 Dec;29(12):2239-44. doi: 10.1097/00003246-200112000-00001. — View Citation
Sirvent JM, Torres A, El-Ebiary M, Castro P, de Batlle J, Bonet A. Protective effect of intravenously administered cefuroxime against nosocomial pneumonia in patients with structural coma. Am J Respir Crit Care Med. 1997 May;155(5):1729-34. doi: 10.1164/ajrccm.155.5.9154884. — View Citation
Valles J, Peredo R, Burgueno MJ, Rodrigues de Freitas AP, Millan S, Espasa M, Martin-Loeches I, Ferrer R, Suarez D, Artigas A. Efficacy of single-dose antibiotic against early-onset pneumonia in comatose patients who are ventilated. Chest. 2013 May;143(5):1219-1225. doi: 10.1378/chest.12-1361. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU-free days | From admission to 30 days, death, or hospital discharge, whichever occurs first | ||
Secondary | Ventilator-free days | From admission to 30 days, death, or hospital discharge, whichever occurs first | ||
Secondary | Hospital-free days | From admission to 30 days, death, or hospital discharge, whichever occurs first | ||
Secondary | Antibiotic-free days | Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first | ||
Secondary | Intubated after enrollment | Yes/no | Between admission to 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Tracheostomy after enrollment | Yes/no | Between admission to 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Developed pneumonia after enrollment | Yes/no, by criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions | Between admission to 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Days before developing pneumonia criteria | By criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions | Between admission to 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Additional antibiotics prescribed | Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics. | Between admission to 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Positive sputum culture with presumed pathogen | Yes/no | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Any positive culture with organism resistant to prophylactic antibiotics | Yes/no | Between admission and 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Positive C. Difficile stool toxin assay after enrollment | Yes/no | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first | |
Secondary | Temperature >38 centigrade on day 3 | Yes/no | Day 3 after enrollment | |
Secondary | White blood cell count >11k on day 3 | Yes/no | Day 3 after enrollment | |
Secondary | Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3 | Yes/no | Day 3 after enrollment | |
Secondary | Purulent secretions | Yes/no | Day 3 after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04083677 -
Routine Point of Care Ultrasound (POCUS) Assessment of Antral Gastric Contents in Traumatic Surgical Patients for Prevention of Aspiration Pneumonitis
|
||
Terminated |
NCT05101668 -
Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke
|
N/A | |
Completed |
NCT02588495 -
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
|
N/A | |
Completed |
NCT02576756 -
Retrospective Study in Patients Who Have Had a Difficult Intubation.
|
N/A | |
Completed |
NCT01777672 -
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia
|
Phase 2 | |
Completed |
NCT05033041 -
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
|
Phase 4 | |
Completed |
NCT01011803 -
Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study
|
N/A | |
Recruiting |
NCT06137976 -
Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy
|
N/A | |
Completed |
NCT04645043 -
Ultrasound Guided Esophageal Pressure
|
N/A | |
Completed |
NCT01807884 -
Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT03573609 -
Evaluation of the Effectiveness and Safety of Supratube Device
|
N/A | |
Completed |
NCT03555604 -
Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
|
||
Enrolling by invitation |
NCT04411290 -
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
|
||
Completed |
NCT05734937 -
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
|
N/A | |
Recruiting |
NCT05330351 -
Gastric Ultrasound in Pediatric Trauma Patients
|
||
Terminated |
NCT02437513 -
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
|
N/A | |
Completed |
NCT04786691 -
How do You Take Your Coffee Before Anesthesia
|
N/A | |
Completed |
NCT05434442 -
Caregivers Tracheal Aspiration Training
|
N/A | |
Completed |
NCT03305757 -
Seroma Reduction After Mastectomy
|
Phase 4 | |
Active, not recruiting |
NCT04202887 -
The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial
|
N/A |