Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

OPD *

Yes No

IPD *

Yes No

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients presented to the OPD or admitted to the IPD with confirmed case of CAP *

Yes No

Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Severity of current illness *

Previous antibiotics used (if any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Microbiological culture isolated *

Yes No

Laboratory tests performed for the confirmation of microbiological culture isolates? *

Which specific organism is isolated? (If available)

Microbial antigen testing results(If available)

Molecular Tests (PCR) results (If available)

Other Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

CBC

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/L)

ESR (mm/hr)

Procalcitonin (ng/mL)

LFT

Bilirubin (T/D/I) (mg/dL)

SGPT (U/L)

SGOT (U/L)

ALP (U/L)

Protein (T/A/G) (g/dL)

RFT

S.Cr (mg/dL)

BUN (mg/dL)

eGFR (mL/min/1.73m²)

Specify others (if available)

Brand Name *

Dose *

Frequency *

Duration *

Other antibiotic prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days) *

Microbiological culture isolated *

Yes No

Laboratory tests performed for the confirmation of microbiological culture isolates? *

Which specific organism is isolated? (If available)

Microbial antigen testing results(If available)

Molecular Tests (PCR) results (If available)

Other Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

CBC

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/L)

Procalcitonin (ng/mL)

ESR (mm/hr)

CRP (mg/L)

LFT

Bilirubin (T/D/I) (mg/dL)

SGPT (U/L)

SGOT (U/L)

ALP (U/L)

Protein (T/A/G) (g/dL)

RFT

S.Cr (mg/dL)

BUN (mg/dL)

eGFR (mL/min/1.73m²)

Specify others (if available)

Signs and Symptoms (if any)

Cure Improvement Worsening Mortality

Need for intensive care unit (ICU) admission (if available) {{-- --}}

Yes No {{-- Yes --}}

Adverse events noted due to study medication *

Yes No {{-- Yes --}}

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If ‘Treatment given ‘is ticked as ‘Yes’ then relevant information should be captured on Prior and concomitant Medication Form.Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Ceftriaxone CRF

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION *

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results)

CBC

LFT

RFT

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - END OF THERAPY

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results)

CBC

LFT

RFT

CLINICAL DATA

ADVERSE EVENTS