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Under-enrollment
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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.
ICU patients with signs of aspiration on imaging and a clinical history supportive of aspiration, but with no clear signs of infectious pneumonia, will be randomized to receive either 5 days of empiric antibiotics or supportive care only. They will be followed for 30 days with a primary outcome of ICU length-of-stay and various secondary outcomes including mortality, ventilator days, and antibiotic days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Experimental | 5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum. Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. |
|
| Control | No Intervention | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone | Drug | If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-free Days | Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure. | From admission to 30 days, death, or hospital discharge, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free Days | Number of days without any mechanical ventilation, between date of admission and 30 days afterwards. Death, discharge, or mechanical ventilation can both reduce this measure. | From admission to 30 days, death, or hospital discharge, whichever occurs first |
| Hospital-free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Oto | UConn Health, Adult Critical Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health, John Dempsey Hospital | Farmington | Connecticut | 06030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29438467 | Background | 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. | |
| 15754197 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics | 5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum. Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. Ceftriaxone: If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days Amoxicillin clavulanic acid: At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days Cefepime: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin Vancomycin: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (AUC/MIC) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hr, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q 24 hours for the remainder of 5 days |
| FG001 | Control | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics | 5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum. Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. Ceftriaxone: If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days Amoxicillin clavulanic acid: At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days Cefepime: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin Vancomycin: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (AUC/MIC) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ICU-free Days | Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure. | Posted | Mean | Standard Deviation | days | From admission to 30 days, death, or hospital discharge, whichever occurs first |
|
30 days from enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotics | 5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum. Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin. Ceftriaxone: If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days Amoxicillin clavulanic acid: At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days Cefepime: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin Vancomycin: If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hours, clinicians may transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q24 hours for the remainder of 5 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Oto | UConn Health | 18606792000 | 3881 | oto.brandon@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2022 | Sep 22, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D000077723 | Cefepime |
| D014640 | Vancomycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Amoxicillin clavulanic acid | Drug | At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days |
|
|
| Cefepime | Drug | If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin |
|
| Vancomycin | Drug | If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (area under the curve/minimum inhibitory concentration) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if MRSA swab is negative. |
|
| Levofloxacin | Drug | At any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days |
|
Number of days not spent in the hospital, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure. |
| From admission to 30 days, death, or hospital discharge, whichever occurs first |
| Antibiotic-free Days | Number of days without any antibiotics administered, between date of admission and 30 days afterwards. Death, discharge, or antibiotic use can all reduce this measure. | Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants Intubated After Enrollment | Yes/no | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants Who Underwent Tracheostomy After Enrollment | Yes/no | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants Who 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 |
| 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 |
| Number of Participants Prescribed Additional Antibiotics After Enrollment | Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics. | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants With a Positive Sputum Culture With a Presumed Pathogen | Yes/no | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants With Any Positive Culture With an Organism Resistant to Prophylactic Antibiotics | Yes/no | Between admission and 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants With a Positive C. Difficile Stool Toxin Assay After Enrollment | Yes/no | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first |
| Number of Participants With a Temperature >38 Centigrade on Day 3 | Yes/no | Day 3 after enrollment |
| Number of Participants With a White Blood Cell Count >11k on Day 3 | Yes/no | Day 3 after enrollment |
| Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3 | Yes/no | Day 3 after enrollment |
| Number of Participants With Purulent Secretions on Day 3 | Yes/no | Day 3 after enrollment |
| 30 Day Mortality | Death within 30 days from enrollment | 30 days |
| 25129577 | Background | 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. |
| 12689848 | Background | 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. |
| 31693806 | Background | 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. |
| 28594680 | Background | 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. |
| 31573350 | Background | 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. |
| 20469622 | Background | Marik PE. Aspiration syndromes: aspiration pneumonia and pneumonitis. Hosp Pract (1995). 2010 Feb;38(1):35-42. doi: 10.3810/hp.2010.02.276. |
| 9925081 | Background | 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. |
| 11801813 | Background | 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. |
| 9154884 | Background | 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. |
| 23715136 | Background | 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. |
| BG001 | Control | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Intubated prior to enrollment | Count of Participants | Participants |
|
| Chronic tracheostomy | Count of Participants | Participants |
|
| Current steroid use at time of enrollment | Count of Participants | Participants |
|
| Witnessed aspiration event, prior to admission | Count of Participants | Participants |
|
| Days between hospital admission and enrollment | Mean | Standard Deviation | days |
|
| Pneumonia diagnosed prior to enrollment | Count of Participants | Participants |
|
| Positive serum ethanol at time of admission | Count of Participants | Participants |
|
| Positive sputum culture prior to enrollment | Count of Participants | Participants |
|
| OG001 | Control | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. |
|
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| Secondary | Ventilator-free Days | Number of days without any mechanical ventilation, between date of admission and 30 days afterwards. Death, discharge, or mechanical ventilation can both reduce this measure. | Posted | Mean | Standard Deviation | days | From admission to 30 days, death, or hospital discharge, whichever occurs first |
|
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| Secondary | Hospital-free Days | Number of days not spent in the hospital, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure. | Posted | Mean | Standard Deviation | days | From admission to 30 days, death, or hospital discharge, whichever occurs first |
|
|
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| Secondary | Antibiotic-free Days | Number of days without any antibiotics administered, between date of admission and 30 days afterwards. Death, discharge, or antibiotic use can all reduce this measure. | Posted | Mean | Standard Deviation | days | Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants Intubated After Enrollment | Yes/no | Posted | Count of Participants | Participants | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants Who Underwent Tracheostomy After Enrollment | Yes/no | Posted | Count of Participants | Participants | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants Who 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 | Posted | Count of Participants | Participants | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
|
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|
| 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 | Posted | Mean | Standard Deviation | days | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants Prescribed Additional Antibiotics After Enrollment | Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics. | Posted | Count of Participants | Participants | Between admission to 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants With a Positive Sputum Culture With a Presumed Pathogen | Yes/no | Posted | Count of Participants | Participants | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first |
|
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| Secondary | Number of Participants With Any Positive Culture With an Organism Resistant to Prophylactic Antibiotics | Yes/no | Posted | Count of Participants | Participants | Between admission and 30 days, death, or hospital discharge, whichever occurs first |
|
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| Secondary | Number of Participants With a Positive C. Difficile Stool Toxin Assay After Enrollment | Yes/no | Posted | Count of Participants | Participants | Between enrollment and 30 days, death, or hospital discharge, whichever occurs first |
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| Secondary | Number of Participants With a Temperature >38 Centigrade on Day 3 | Yes/no | Posted | Count of Participants | Participants | Day 3 after enrollment |
|
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| Secondary | Number of Participants With a White Blood Cell Count >11k on Day 3 | Yes/no | Posted | Count of Participants | Participants | Day 3 after enrollment |
|
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| Secondary | Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3 | Yes/no | Posted | Count of Participants | Participants | Day 3 after enrollment |
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| Secondary | Number of Participants With Purulent Secretions on Day 3 | Yes/no | Posted | Count of Participants | Participants | Day 3 after enrollment |
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| Secondary | 30 Day Mortality | Death within 30 days from enrollment | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 1 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Control | No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D012140 |
| Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |