Case Report Form “Anti-Influenza Therapy in Hospitalized patients with Community-Acquired Pneumonia” January 2012 Principal Investigator: _________________ Hospital: ____________________ Subject Name: ___________________________________________ Medical Record Number: _____________________ Case # _______ January 2012 Page 1 of 19 DEMOGRAPHICS Sex: Age: ______________ Weight: __________ Height: ___________ Data collection form done: Ο Prospective Ο Retrospective Date of Arrival to Hospital: ______________ Time of Arrival to Hospital: ______________ Was the patient admitted to an intensive care unit on admission to the hospital? Ο Yes Ο No Did the patient need ventilatory support? Ο Invasive mechanical ventilation Ο Non-invasive mechanical ventilation (e.g. CPAP/Bilevel) Ο No Did the patient need blood pressure support? Ο Fluid resuscitation Ο Vasopressors Ο No Was the patient transferred to an intensive care unit during the hospitalization? Ο Yes Date: ___________ Ο No Date of Discharge from the ICU: ______________ Date of Discharge from the hospital: ______________ Abstractor: _________________________ • If you have any questions regarding data collection please e-mail your question to Paula Peyrani, MD at [email protected] Case # _______ January 2012 Page 2 of 19 1. DIAGNOSIS OF CAP Chest X-ray/CT scan within 24 hours of admission (CT scan overrides CXR findings) Date of x-ray ______________ Time of x-ray ______________ • New pulmonary infiltrate RUL RML RLL LUL LLL Unspecified location Cavitation Interstitial Bilateral Infiltrate Normal • Pleural effusion Ο None Ο Right Ο Left Ο Bilateral Date of CT scan ______________ Time of CT scan ______________ Ο Not done • New pulmonary infiltrate RUL RML RLL LUL LLL Unspecified location Cavitation Interstitial Bilateral Infiltrate Normal • Pleural effusion Ο None Ο Right Ο Left Ο Bilateral Criteria for diagnosis of CAP*: A. New pulmonary infiltrate (at time of hospitalization) Ο Yes Ο No B. New or increased cough with/without sputum production Ο Yes Ο No C. Fever >37.8o C (100.0o F) or hypothermia <35.6o C (96.0o F) Ο Yes Ο No D. Changes in WBC (leukocytosis, left shift, or leukopenia) Ο Yes Ο No *Diagnosis of CAP requires the presence of criteria A (new pulmonary infiltrate) plus at least one of criteria B, C, or D. Diagnosis Ο CAP Ο COPD Exacerbation Ο acute bronchitis If patient doesn’t meet CAP criteria, the case SHOULD NOT be entered in the study web site Comment: ___________________________________________________________________________ Case # _______ January 2012 Page 3 of 19 2. HISTORY AND PHYSICAL AT ADMISSION 2.1. Number of days with respiratory symptoms before admission _____ days Unknown 2.2 Past medical history Neoplastic disease (active or within the last year) Ο Yes Ο No Congestive heart failure Ο Yes Ο No Cerebrovascular disease Ο Yes Ο No Renal disease Ο Yes Ο No Liver disease Ο Yes Ο No Chronic Renal Failure Ο Yes Ο No Neurologic Diseases/Mental Illness Ο Yes Ο No Diabetes Ο Yes Ο No Prior Admission for CAP within 1 year Ο Yes Ο No Suspicion of Aspiration Ο Yes Ο No Cirrhosis Ο Yes Ο No Asplenia Ο Yes Ο No Acute alcoholism/alcoholic withdrawal Ο Yes Ο No IV steroids on admission: Ο Yes Ο No name ___________ dose ___________ On oral steroids prior to admission Ο Yes Ο No COPD Ο Yes Ο No If available, last FEV1 within the previous year ___________ Home O2 Ο Yes Ο No HIV positive Ο Yes Ο No If available, last CD4 within the previous year (absolute) ___________ last CD4 within the previous year (%) ___________ last viral load within the previous year ___________ Duration of HIV seropositivity in years ___________ On HAART Ο Yes Ο No Current episode of CAP as initial presentation of HIV Ο Yes Ο No Prior AIDS defining illness Ο Yes Ο No Intravenous drug use Ο Yes Ο No Prior history of pneumonia Ο Yes Ο No Prior history of PCP Ο Yes Ο No Prior history of tuberculosis Ο Yes Ο No Antibiotic prophylaxis for PCP or MAC Ο Yes Ο No 2.3 Risk factors for healthcare-associated pneumonia (HCAP) Nursing home resident Ο Yes Ο No Hospitalized ≥ 2 days in the prior 90 days Ο Yes Ο No IV antibiotic therapy in the prior 90 days Ο Yes Ο No Home infusion therapy (including ABT and chemotherapy) Ο Yes Ο No Chronic dialysis within prior 30days Ο Yes Ο No Home wound care Ο Yes Ο No Case # _______ January 2012 Page 4 of 19 2.4 Risk factors for Cardiovascular Events Family history of Coronary Artery Disease Ο Yes Ο No Active Coronary Artery Disease Ο Yes Ο No Essential arterial hypertension Ο Yes Ο No Hyperlipidemia Ο Yes Ο No Prior myocardial infarction Ο Yes Ο No Prior PTCA / CABG / angioplasty Ο Yes Ο No Atrial fibrillation Ο Yes Ο No 2.5 Cardiovascular medications prior hospital admission Aspirin Ο Yes Ο No Beta-blockers Ο Yes Ο No ACE - I Ο Yes Ο No Warfarin Ο Yes Ο No Heparin Ο Yes Ο No Antiplatelet: Ο Yes Ο No Statins: Ο Yes Ο No 2.6 Physical examination on admission Altered mental status on admission Ο Yes Ο No Heart rate ___________ Respiratory rate ___________ Systolic blood pressure ___________ Diastolic blood pressure ___________ Temperature ___________ O2 saturation ___________  Not done 2.7 Laboratory findings Hematocrit: ________  Not done Hemoglobin: ________  Not done WBC: _________  Not done Bands: _________  Not done Platelet Count: ________  Not done Serum Sodium: ________  Not done Serum Potassium: ________  Not done Serum BUN: ________ units _______  Not done Serum Creatinine: ________  Not done Serum Bicarbonate: ________  Not done Serum Glucose: ________  Not done Albumin: ________  Not done Serum Troponin I or T (1) ___________ (2) ___________ (3) ____________  Not done Serum CK-MB (1) ___________ (2) ___________ (3) ____________  Not done LDL: ________  Not done HDL: ________  Not done LDH: ________  Not done Cholesterol: ________  Not done Trygliceride: ________  Not done Lactate: ________ units _______ elevated? Ο Yes Ο No  Not done BNP: ________  Not done C-Reactive protein: ________ units _______ elevated? Ο Yes Ο No  Not done Procalcitonin: ________ units _______ elevated? Ο Yes Ο No  Not done Case # _______ January 2012 Page 5 of 19 Vitamin D _ _______ units _______ elevated? Ο Yes Ο No  Not done 2.7 Laboratory findings (continuation) ABG: pH ________  Not done PaCO2 ________ PaO2 ________ Bicarbonate ________ FiO2 ________ ** PSI score, CURB-65, and CRB-65 will be automatically calculated once all data have been entered ** Comment: ______________________________________________________________________________ 3. RISK FACTORS FOR TUBERCULOSIS Check all that apply: Symptoms: Night sweats Hemoptysis Weight loss Hoarseness Member of High Risk Group: HIV/AIDS positive History of TB History of positive PPD Age > 65 years Homeless Community living (prison, nursing home, shelter) Alcohol/Drug abuse Recent exposure to Active TB Health care worker From area with high risk of tuberculosis History of Chronic Illness: Silicosis Diabetes Mellitus End-Stage Renal Disease Hematologic disease Gastrectomy Intestinal bypass Cancer of Mouth or GI Tract Chronic Malabsorption Syndrome 10% or below ideal body weight Long term cortisone therapy Other immunosuppressive state Number of risk factors present: _____ Was patient diagnosed with pulmonary tuberculosis? Ο Yes Ο No If Yes, enter the following information: AFB smears positive Cultures positive Source: ______________ DNA amplification positive Resistant Mycobacterium Tuberculosis Comment: ______________________________________________________________________________ Case # _______ January 2012 Page 6 of 19 4. MICROBIOLOGICAL WORK-UP Was the following work-up performed? Respiratory cultures: Ο Yes Ο No Date: __________ Blood cultures: Ο Yes Ο No Date: __________ Pneumococcal urinary antigen: Ο Yes Ο No Date: __________ Legionella urinary antigen: Ο Yes Ο No Date: __________ Rapid flu test? Ο Yes Ο No Date: __________ Respiratory Viral Panel Ο Yes Ο No Date: __________ Was the cause of the pneumonia identified? Ο Yes Ο No Sample collection date: ________________ If yes, what organism(s) were identified as the cause? Organism 1: ____________________________ Relevant susceptibilities: What source(s)? - check all that apply ____________________________ Blood Urinary antigen Sputum Serology ____________________________ Tracheal aspirate Other: _________________ BAL ____________________________ Comment: ______________________________________________________________________________ Organism 2: ____________________________ Relevant susceptibilities: What source(s)? - check all that apply ____________________________ Blood Urinary antigen Sputum Serology ____________________________ Tracheal aspirate Other: _________________ BAL ____________________________ Comment: ______________________________________________________________________________ Case # _______ January 2012 Page 7 of 19 5. ANTIBIOTIC THERAPY ! Did the patient receive oral antibiotics during the last 30 days? Ο Yes Ο No ! Was the antibiotic given for the treatment of CAP? Ο Yes Name: _________ ____________ Ο No ! Did the patient fail outpatient oral antibiotic therapy for CAP? Ο Yes Ο No 5.1 Antibiotics received for empiric therapy of CAP For the purpose of this clinical trial, “empiric therapy” is defined as all antibiotics started during the first 24 hours of hospitalization. Collect only the antibiotics (IV, PO, IM) STARTED during the first 24 hours of hospitalization (use date and time when the antibiotics were given; do not use physician’s orders). ! Initial antibiotic given