CTRI/2022/07/044190进行中（未招募）4 期
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.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 10
- 主要终点
- Proportion of patients having clinical success (clinical cure, clinical improvement) at the end of TOC visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
- •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.
排除标准
- •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.
- •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).
- •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.
- •Patients with history of rheumatic or valvular heart disease or glomerulonephritis.
- •Patients requiring hospitalization or parenteral antibiotic treatment.
- •Patients who have received antibiotic treatment for ≥ 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented).
- •Patients with history of neoplasia or immunosuppression or on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS).
- •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.
- •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.
- •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).
- •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).
- •Patients with concomitant condition requiring non-study antibacterial therapy.
- •Patients with involvement of perianal area, facial cellulitis or cellulitis associated with animal or human bite (except insect bite).
- •Patients with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement.
- •Patients on chronic immunosuppressive therapy, including use of high dose corticosteroids (≥40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS).
- •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.
- •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.
- •Patients unwilling or unable to comply with the study procedures.
- •Patients who have participated in another investigational study in the past 3 months prior to enrollment in this study.
结局指标
主要结局
Proportion of patients having clinical success (clinical cure, clinical improvement) at the end of TOC visit
时间窗: Visit 4, Test of Cure (TOC) | Maximum 20 days (for URTI patients) | Maximum 25 days (For uSSTI patients)
次要结局
- 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))
研究者
研究点 (10)
Loading locations...
相似试验
尚未招募
4 期
A clinical trial to study the effects of three drugs, Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in treatment of essential high blood pressure in IndiaCTRI/2019/01/016858Sun Pharma Laboratories Limited330
已完成
4 期
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry DiseaseFabry DiseaseNCT00140621Genzyme, a Sanofi Company6
招募中
4 期
A study to assess the safety and efficacy of fixed dose combination of Montelukast 10 mg plus Acebrophylline SR 200 mg tablet in patients having bronchial asthmaCTRI/2020/02/023237Sun Pharma Laboratories Limited206
进行中（未招募）
4 期
A study to evaluate the safety and efficacy of Dienogest in patients suffering from endometriosisCTRI/2020/10/028556Jagsonpal Pharmaceuticals Limited200
招募中
4 期
A Clinical Study to Evaluate the Safety and Efficacy of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in hepatitisCTRI/2022/06/043453Win Medicare Pvt Ltd220