Alkem

Subject ID *

Subject Initials *

Investigator*

Centre *

Date of Assessment *

Subject Initials *

OPD *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients with dental infection presented to the OPD *

Yes No

Clinical signs and symptoms : (fever, redness, bleeding gums, bleeding on probing, halitosis, pus discharge, abscess, pericoronitis, trismus, etc.) *

Pain on VAS *

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

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Tests	Assessment 1 Result
WBC (cumm)
CRP (mg/L)
ESR (mm/hr)

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (mg/L)

ESR (mm/hr)

Specify Others (if any)

Co-Amoxiclav 625 tablets 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 Therapy (days) *

Any Bacterial Species isolated*

Yes No

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Clinical Signs and Symptoms (if any)

Pain on VAS

Overall Assessment

Cure Improvement Worsening

Requirement of additional antimicrobial therapy (if any)

Tests	Assessment 2 Result
WBC (cumm)
CRP (mg/L)
ESR (mm/hr)

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (cumm)

ESR (mg/L) (mm/hr)

Specify Others (if any)

Adverse events noted due to study medication *

Yes No {{-- If, 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

Date of Assessment

Duration of Hospital Stay (days)

Hb (gm/dL)

RBC (millions/cumm)

WBC (cumm)

Platelets (cumm)

CRP (cumm)

ESR (mg/L) (mm/hr)

Specify others (if available)

Any Bacterial Species isolated

Yes No

Sensitivity results (if available)

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Clinical signs and symptoms 1: (fever, redness, bleeding gums, bleeding on probing, halitosis, pus discharge, abscess, pericoronitis, trismus, etc.)

Pain on VAS

Overall Assessment

Cure Improvement Worsening

Any secondary infections (details if yes)

Relapse of infection (details if yes)

Requirement of additional antimicrobial therapy (if any)

Adverse events noted due to study medication

Yes No {{-- If, 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

Amoxiclav in dental infection

ASSESSMENT 1 - BASELINE VISIT - DAY 0

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

MICROBIOLOGICAL DATA

VITALS

LABORATORY PARAMETERS (Reports & Value)

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - FIRST FOLLOW-UP VISIT

DATE OF ASSESSMENT

MICROBIOLOGICAL DATA

VITALS

CLINICAL DATA

LABORATORY PARAMETERS (Reports & Value)

ADVERSE EVENTS

ASSESSMENT 3 - SECOND FOLLOW-UP VISIT

DATE OF ASSESSMENT

LABORATORY PARAMETER (Reports & Value)

MICROBIOLOGICAL DATA

VITALS

CLINICAL DATA

ADVERSE EVENTS