CTRI/2022/07/044190 [Registered on: 20/07/2022] Trial Registered Prospectively
Last Modified On:
28/07/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Other
Public Title of Study
Cephalexin Extended Release and Clavulanate Potassium Tablets in Patients with Upper Respiratory Tract Infection and Uncomplicated Skin & Soft Tissue Infection.
Scientific Title of Study
A Multicenter, Open label Study to Assess Safety and Efficacy of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in Patients with Upper Respiratory Tract Infection and Uncomplicated Skin & Soft Tissue Infection.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
ICR/18/008, Protocol Version No. 2.1, dated 04/JAN/2021.
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Suyog Mehta
Designation
Vice President and Head - Medical Affairs and Clinical Research, India and EM
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai MAHARASHTRA 400063 India
Phone
919987531040
Fax
02243244343
Email
suyog.mehta@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Piyush Patel
Designation
Medical Monitor – DGM
Affiliation
Sun Pharma Laboratories Ltd
Address
Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E),
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
piyush.patel5@sunpharma.com
Details of Contact Person Public Query
Name
Rajesh Gaikwad
Designation
Deputy General Manager – Operations
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1,Western Express Highway,
Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
rajesh.gaikwad@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Ltd, Tandalja, Vadodara-390020, Gujarat, India
Primary Sponsor
Name
Sun Pharma Laboratories Ltd
Address
Sun Pharma Laboratories Ltd, Tandalja, Vadodara-390020, Gujarat, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Raptim Research Pvt Ltd
A-226 and PAP-213 (Clinical Unit) ;
A-242 ( Bioanalytical and Biostatistical Unit);
T.T.C., Industrial Area, Mahape M.I.D.C.,
Navi Mumbai - 400 710, India.
Ethics Committee, SMS medical college and attached hospital
Approved
IEC, Sparsh Hospital
Approved
Institutional Ethics Committee of Ayush Hospital
Approved
Institutional Ethics Committee, GGMC Mumbai
Approved
Institutional Ethics Committee, GGMC Mumbai
Approved
Lotus Ethics Committee
Approved
O and P Ethics Committee
Approved
Opal Institutional Ethics Committee
Approved
Pagarav Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets
(375 mg + 125 mg) and (750 mg + 125 mg), Orally, Twice daily approximately 12 hours apart with food.
Total Study Duration:
Maximum 20 days (for URTI patients)
Maximum 25 days (For uSSTI patients)
Total Study Treatment period: 10 Days
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Inclusion Criteria for Upper Respiratory Tract Infection (URTI) Patients
1)Patients of either sex, aged 12 to 65 years (both inclusive), who have given written informed consent/assent to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from patients aged <18 years
2)Patients with confirmed diagnosis of acute upper respiratory tract infection (pharyngitis, tonsillitis or pharyngotonsillitis) based on modified Centor score (McIsaac score) ≥ 3 and positive for rapid antigen test (RADT) during the screening period.
Inclusion Criteria for Uncomplicated Skin & Soft Tissue Infection (uSSTI) Patients
1)Patients of either sex, aged 12 to 65 years (both inclusive), who have given written informed consent/assent to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from patients aged <18 years.
2)Patients with confirmed diagnosis of uncomplicated skin and soft tissue infections (uSSTI) and culturable microbiological specimen, with an onset of infection ≤ 7 days requiring antibiotic therapy. Acceptable clinical diagnosis of uSSTIs include: simple abscess, impetigo, furunculosis, carbuncles, cellulitis (area <10 cm2), erysipelas, folliculitis, paronychia, superficial wound infections (traumatic, post-surgical) etc.
3)Patients with at least three or more of the following local signs and symptoms of uSSTI accompanied with or without systemic features of infection such as pain/tenderness, purulent drainage/discharge, erythema with or without induration, swelling, fluctuance, heat/localized warmth, regional lymph node swelling or tenderness and/or extension of redness.
ExclusionCriteria
Details
Exclusion Criteria for Upper Respiratory Tract Infection Patients:
1)Patients with history of hypersensitivity to cephalexin, other cephalosporins, penicillins, clavulanate potassium or other beta-lactam class of antibiotics or any of the excipients of study formulation.
2)Patients with infection of the deep tissues of the upper respiratory tract (e.g. epiglottitis, retropharyngeal or buccal cellulitis or abscess of the retropharynx/ tonsil or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (e.g. sinusitis, otitis media or orbital/periorbital cellulitis).
3)Patients with concurrent symptoms suggestive of viral etiology including conjunctivitis, coryza and cough; diffuse adenopathy or rash suggestive of mononucleosis; rash or arthropathy suggestive of scarlet fever.
4)Patients with history of rheumatic or valvular heart disease or glomerulonephritis.
5)Patients requiring hospitalization or parenteral antibiotic treatment.
6)Patients who have received antibiotic treatment for ≥ 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented).
7)Patients with history of neoplasia or immunosuppression or on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS).
8)Patients with significant disease(s) (such as uncontrolled metabolic disorders, cancer etc.) or disorder(s) other than the disease in consideration that in the opinion of the investigator may (i) put the patient at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding patient’s ability to participate in the study or (iv) needs an additional anti-microbial agent
9)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.
10)Patients unwilling or unable to comply with the study procedures
11)Patients who have participated in another investigational study in the past 3 months prior to enrollment in this study.
Exclusion Criteria for Uncomplicated Skin & Soft Tissue Infection (uSSTI) Patients:
1)Patients with history of hypersensitivity to cephalexin, other cephalosporins, penicillins or other beta-lactam class of antibiotics, clavulanate potassium or any of the excipients of study formulation.
2)Patients requiring hospitalization or parenteral antibiotic treatment.
3)Patients with complicated acute bacterial skin and skin structure infections (ABSSSI) as judged by the investigator or with chronic or underlying skin condition at the site of infection (e.g., a secondarily infected atopic dermatitis, eczema, acne vulgaris or burn wounds) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic instruments).
4)Patients who have received antibiotic treatment for ≥ 24 hours during the 72 hours period prior to enrollment in the study (unless treatment failure was documented).
5)Patients with concomitant condition requiring non-study antibacterial therapy.
6)Patients with involvement of perianal area, facial cellulitis or cellulitis associated with animal or human bite (except insect bite).
7)Patients with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement.
8)Patients on chronic immunosuppressive therapy, including use of high dose corticosteroids (≥40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS).
9)Patients with a history of clinically significant diseases (such as uncontrolled metabolic disorders, cancer etc.) or disorders (other than the disease in consideration) that in the opinion of the investigator may (i) put the patient at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding patient’s ability to participate in the study.
10)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.
11)Patients unwilling or unable to comply with the study procedures.
12)Patients who have participated in another investigational study in the past 3 months prior to enrollment in this study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of patients having clinical success (clinical cure, clinical improvement) at the end of TOC visit
Visit 4, Test of Cure (TOC)
Maximum 20 days (for URTI patients)
Maximum 25 days (For uSSTI patients)
Secondary Outcome
Outcome
TimePoints
Proportion of patients having Microbiological success (microbiological outcome of “Documented Eradicationâ€, “Presumed Eradicationâ€) at the end of TOC visit.
Visit 4, Test of Cure (TOC)
Maximum 20 days (for URTI patients)
Maximum 25 days (For uSSTI patients)
Target Sample Size
Total Sample Size="230" Sample Size from India="230" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Multicenter, Open label phase IV Study to Assess Safety and Efficacy of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in Patients with Upper Respiratory Tract Infection and Uncomplicated Skin & Soft Tissue Infection. In this study as per the routine clinical practice patients will be attending the scheduled visits. So there will be total 4 visits, Visit 1: Screening and/ or Enrollment, Visit 2: On therapy visit, Visit 3: End of Treatment and Visit 4: Test of Cure (TOC). Apart from the scheduled visits, the patient can visit clinical site on any day and thie will be termed as unscheduled visit. This study will be managed by Raptim Research Pvt Ltd.