| CTRI Number |
CTRI/2010/091/001153 [Registered on: 11/08/2010] |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of FDC of Cephalexin Extended Release and Clavulanate Potassium Tablets in patients with uncomplicated skin and soft tissue infections. |
Scientific Title of Study
Modification(s)
|
"Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections" |
| Trial Acronym |
FDC of Cephalexin ER and Clavulanate Potassium Tablets in the treatment of uSSTI |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RCEPCL093004 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Amit Nasa |
| Designation |
Project Leader |
| Affiliation |
Ranbaxy Research Laboratories |
| Address |
Project Leader, Ranbaxy Laboratories Ltd.
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India |
| Phone |
01244194344 |
| Fax |
01244016855 |
| Email |
amit.nasa@ranbaxy.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Sanjay K Sharma |
| Designation |
Associate Director |
| Affiliation |
Ranbaxy Research Laboratories |
| Address |
Medical Monitor, Ranbaxy Laboratories Ltd.
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India |
| Phone |
01244107004 |
| Fax |
01244016855 |
| Email |
sanjayk.sharma2@ranbaxy.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Amit Nasa |
| Designation |
Project Leader |
| Affiliation |
Ranbaxy Research Laboratories |
| Address |
Project Leader, Ranbaxy Laboratories Ltd
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India |
| Phone |
01244194344 |
| Fax |
01244016855 |
| Email |
amit.nasa@ranbaxy.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ranbaxy Laboratories Ltd., Plot No. 77-B, Sector 18, IFFCO Road,Gurgaon - 122015 , Haryana |
|
Primary Sponsor
Modification(s)
|
| Name |
Ranbaxy Laboratories Ltd |
| Address |
MACR, Ranbaxy Research Laboratories, Ltd, Plot No. 77-B, Sector 18, IFFCO Road, Gurgaon - 122015 , Haryana |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. L. Aarthi |
Aarthi Skin Care Clinic |
Aarthi Skin Care Clinic,Old No. 32, Kummalamman Koil Street-600081
Chennai
TAMIL NADU |
044-42872295
draarthi_derm@hotmail.com |
| Dr. Govind Saini |
Amar Medical and Research Center |
Amar Medical and Research Center,Kiran Path, Mansarovar-302020
Jaipur
RAJASTHAN |
0141-2391892
shellraj@gmail.com |
| Dr. Rajesh P Singh |
Government Medical College & Hospital |
Department of Skin & VD,,Government Medical College & Hospital-440003
Nagpur
MAHARASHTRA |
09373107692
rpsingh133@rediffmail.com |
| Dr. Riyaz Aamir |
Khobragade Hosp |
Khobragade Hospital, Indora Square,Kamptee Road-440017
Nagpur
MAHARASHTRA |
09822701123
drriyazaamir15@yahoo.com |
| Dr. Yogesh S Marfatia |
Medical college & SSG Hospital |
Department of Skin and VD, OPD # 1,Medical college & SSG Hospital-390 001
Vadodara
GUJARAT |
0265-2424848
ym11256@yahoo.com |
| Dr. Dipesh Duttaroy |
Medical college and SSG Hospital |
Department of surgery, ,Medical college and SSG Hospital-390001
Vadodara
GUJARAT |
0265-2424848
drduttaroy@gmail.com |
| Dr. Dipak Umrigar |
New Civil Hospital |
OPD # 24, First Floor, J-Block,,New Civil Hospital, Majura Gate-395001
Surat
GUJARAT |
09426848684
polyumrigar@yahoo.com |
| Dr. Puneet Goyal |
Renova Skin & Laser Clinic |
Renova Skin & Laser Clinic,,Meera Marg Mansarovar-302004
Jaipur
RAJASTHAN |
0141-2396204
puneetgoyaldr@yahoo.co.in |
| Dr. Hriday Gurbaksh |
SF-068, 1st Floor Galleria Complex |
SF-068, 1st Floor Galleria Complex,DLF-IV-122002
Gurgaon
HARYANA |
09818111218
hriday_gurbaksh@yahoo.com |
| Dr. Vijay Rathore |
Tagore Hospital and Research Center |
Tagore Hospital and Research Center,Mansarovar-302001
Jaipur
RAJASTHAN |
0141-2785555
vijay_rathore@hotmailcom |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Chennai Independent Ethics Committee, Chennai (for Dr L Aarthi) |
Approved |
| Human Research Ethics Commiittee, Govt Medical college, Surat |
Approved |
| IEC for Human Research, Medical College & SSG Hospital, Baroda |
Approved |
| IEC for Human Research, Medical College & SSG Hospital, Baroda |
Approved |
| Institutional Ethics Committee, Government Medical College, Nagpur |
Approved |
| Midcity Independent Ethics Committee, Nagpur (for Dr Riyaz Aamir) |
Approved |
| Swasthya kalyan Ethics Committee, Jaipur (for Dr Govind Saini) |
Approved |
| Swasthya kalyan Ethics Committee, Jaipur (for Dr Hriday Gurbaksh) |
Approved |
| Swasthya kalyan Ethics Committee, Jaipur (for Dr Puneet Goyal) |
Approved |
| Swasthya kalyan Ethics Committee, Jaipur (for Dr Vijay Rathore) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Uncomplicated skin and soft tissue infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Cephalexin extended release and clavulanic potassium |
Cephalexin ER 375mg and clavulanate potassium 125 mg tablets orally, twice daily for 10 days |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who have given written informed consent/assent to participate in the study. Additional written informed consent will be taken from parents/LAR (as applicable) in case assent is taken from subjects aged less then 18 yrs.
2. Subjects of either sex, aged more then or equal to 12 years and weighing more then or equal to 40 kg.
3. Subjects with diagnosis of uncomplicated skin and soft tissue infections with an onset of infection less then 7 days, judged to require antibiotic therapy. Acceptable clinical diagnoses of uSSTIs include, but are not limited to: simple abscess, impetigo, furunculosis, cellulitis, carbuncles, erysipelas, folliculitis, paronychia, superficial wound infections (traumatic, post surgical).
4. The uncomplicated skin and soft tissue infection is accompanied by 2 or more of the following local signs and symptoms with or without systemic features of infection: pain/tenderness, swelling, erythema, localized warmth, purulent drainage/discharge, induration, regional lymph node swelling or tenderness
5. Subjects who have positive pre-treatment culture from microbiological specimen obtained from the skin lesions. Culture will be defined as positive if at least one of the following skin pathogens is identified: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Klebsiella pneumoniae, Proteus mirabilis, Escherichia coli
Note:Â
Microbiological specimens (e.g., pus aspirate, swabs etc. from the site of infection) as appropriate will be collected for microbiological analysis from all subjects as per the Hospital/Clinic protocol or practice
Treatment will be initiated before the results of culture are available. However, when these results become available, suitability of the subject for inclusion in the study will be reviewed at visit 2 (Day 3-5). Subjects with sterile culture or negative culture for predefined pathogens will be withdrawn from the study. Subjects showing clinical improvement with isolate(s) resistant to study drug will be allowed to continue in the study at the discretion of the investigator. Subjects who have persistence or worsening of signs and symptoms or appearance of new signs and symptoms associated with skin lesions after 3 days of treatment will be considered as treatment failures and will be withdrawn from the study
Surgical intervention (drainage, incision of the tissue swelling etc.) as appropriate will be done as per the discretion of the investigator |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins or other beta-lactam class of antibiotics, clavulanate potassium or other beta-lactamase inhibitors or any of the excipients* of study formulation
2. Subjects requiring hospitalization or parenteral antibiotic treatment
3. Subjects who have received antibiotic treatment for >/= 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented)
4. Subjects with a concomitant infection that needs an additional oral or topical anti-microbial agent or which in the opinion of the investigator could preclude evaluation of response to study medication
5. Subject with a complicated skin and soft tissue infection as judged by the investigator
6. A chronic or underlying skin condition at the site of infection (e.g., a secondarily infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic instruments)
7. Subjects with secondarily infected thermal injury (burns) or acne vulgaris
8. Subjects with solitary furuncle, involvement of perianal area, facial cellulitis or cellulitis associated with animal or human bite (except insect bite), diabetic foot ulcers or decubitus ulcers (bed sores) or significant peripheral vascular disease
9. Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement
10. Subjects with clinically significant cardiovascular, hematological (including subjects with bleeding diathesis, on anticoagulant therapy or with vitamin K deficiency), renal, hepatic, endocrinal (including subjects with history of diabetes mellitus), pulmonary, urogenital, gastrointestinal, progressive neurological illness (including subjects with history of epilepsy) or psychiatric illness or any other medical condition that might put the subject at greater risk during study participation
11. Pregnant or breast feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening
12. Subjects with a history of drug or alcohol abuse
13. Subjects unwilling or unable to comply with the study procedures
14. Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study
15. Subjects with history of immuno-suppression or on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS).
16. Subjects with SGOT/AST or SGPT/ALT > 3.0 times upper limit of normal (ULN) or alkaline phosphatase or serum bilirubin >2.0 times ULN or serum creatinine >2.0 mg/dL
*Microcrystalline cellulose; sodium starch glycolate; colloidal anhydrous silica; magnesium stearate; hypromellose; hydroxypropyl cellulose; talc; opadry; polyethylene glycol. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Investigator assessed clinical outcome in clinically evaluable subjects |
At test-of-cure visit (7-9 days after end of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbiological outcome in all microbiologically evaluable subjects |
At test-of-cure visit (7-9 days after end of treatment) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
30/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open-label, non-comparative study with an objective to compare the Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections. The study is to be conducted at 10 centres all over India. The primary outcome is Investigator assessed clinical outcome in clinically evaluable subjects at test-of-cure visit (7-9 days after end of treatment) and secondary outcome is Microbiological outcome in all microbiologically evaluable subjects at test-of-cure visit (7-9 days after end of treatment). |