Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

OPD *

IPD *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Pediatric patients diagnosed with bacterial infection & presented to the OPD or admitted to the IPD *

Yes No

Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Previous antibiotics used (if any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Any Bacterial Species isolated *

Yes No

Details, if yes

Serological test 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)

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)

Cefixime oral suspension 200mg/5ml prescribed *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Date of Assessment *

Total duration of cefixime therapy (days) *

Any Bacterial Species isolated *

Yes No

Details, if yes

Serological test 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)

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

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) (if applicable)

Any Bacterial Species isolated

Yes No

Details, if yes

Serological test 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)

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

Cefixime Paediatric infections

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

ASSESSMENT 3 - POST TREATMENT FOLLOW-UP (7-14 days after end of therapy)(if available)

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETER (test & Results)

CBC

LFT

RFT

CLINICAL DATA

ADVERSE EVENTS