Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Was the medication administered to pregnant women?

Yes No

Patients admitted to the ICU with confirmed Carbapenem-Resistant Enterobacteriaceae Infections*

Yes No

Clinical Diagnosis *

Duration of current illness *

Previous antibiotics used (if any)

Concomitant Disease *	Duration of Disease *

Medication *	Dose *	Frequency *

Laboratory tests performed for the confirmation of carbapenem resistance of the Enterobacteriaceae isolates?

Culture Xpert Carba-R Assay Any Other

Carbapenem-Resistant Enterobacteriaceae isolated

Yes No

Which specific organism is isolated? (if available)

Sensitivity results (if available)

PCR / DNA sequencing data (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

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)

Ceftazidime & Avibactam powder for concentrate for solution for infusion (2g + 0.5g) prescribed: *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (days) *

Laboratory tests performed for the confirmation of carbapenem resistance of the Enterobacteriaceae isolates?

Culture Xpert Carba-R Assay Any Other

Carbapenem-Resistant Enterobacteriaceae isolated

Yes No

Which specific organism is isolated? (if available)

Sensitivity results (if available)

PCR / DNA sequencing data (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

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)

Cure Improvement Worsening Mortality

Adverse events noted due to study medication *

Yes No

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

Date of Assessment

Duration of Hospital Stay (days)

Laboratory tests performed for the confirmation of carbapenem resistance of the Enterobacteriaceae isolates?

Culture Xpert Carba-R Assay Any Other

Carbapenem-Resistant Enterobacteriaceae isolated

Yes No

Which specific organism is isolated? (if available)

Sensitivity results (if available)

PCR / DNA sequencing data (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

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

Any secondary infections during hospital stay (details if yes)

Relapse of infection (details if yes)

Adverse events noted due to study medication

Yes No

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

Ceftazidime RWE

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE

MEDICATION

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results : If available)

LFT

RFT

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - END OF THERAPY

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results)

LFT

RFT

CLINICAL DATA

ADVERSE EVENTS

ASSESSMENT 3 - DISCHARGE

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results)

LFT

RFT

CLINICAL DATA

ADVERSE EVENTS