CTRI/2020/11/028896尚未招募4 期
An Open Label, Multicentric Study to Evaluate Safety and Efficacy of Cefpodoxime Proxetil Sustained Release Tablets in the Patients Having Mild to Moderate Upper Respiratory Tract Infections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 256
- 试验地点
- 10
- 主要终点
- Proportion of participants with adverse events and serious adverse events who have consumed at least one dose of the study medication
研究概览
简要总结
This is a Phase IV, single arm, multicentre, open label study. Thestudy will be conducted at multiple centres in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval.
After obtaining the informed consent/ assent (asapplicable), patients will be screened by undergoing various assessments asmentioned in Schedule of Assessment. Throat swab culture will be done forpharyngitis/tonsillitis/Pharyngotonsillitis patients only. After confirming theeligibility, patients will be enrolled by allotting the enrolment number. Theenrolled patient will take study medication for either 05 to 10 days (200 mg ODin patients of acute pharyngitis/tonsillitis/Pharyngotonsillitis) OR 10 days (400mg OD in patients of acute bacterial sinusitis). This will be the treatmentperiod. After the treatment period patient will undergo Follow-up Visit/ Testof Cure Visit/ (Day 04 – 07 after therapy completion, for Acute Pharyngitis,Tonsillitis OR Pharyngotonsillitis) and (Day 01 – 04 after therapy completion,Acute Bacterial Sinusitis). During the study, assessments will be performed asper Schedule of Assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either gender aged 12 to 65 years (both inclusive)
- •Patient with body weight ≥ 40 kg
- •Patients who are willing to provide written informed consent/assent to participate in the study.
- •An additional written informed consent will be taken from parent/legally acceptable representative (as applicable) in case assent is taken from patient aged ≥ 12 and < 18 years
- •DISEASE SPECIFIC INCLUSION CRITERIA: A.
- •Diagnostic criteria for pharyngitis, tonsillitis or Pharyngotonsillitis: I.
- •Patient with a diagnosis of mild to moderate 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.
- •MacIsaac score parameters-Score a) Body Temperature ≥ 38 oC- 1 b) Absence of cough- 1 c) Swollen, Tender anterior cervical nodes- 1 d) Tonsillar exudate or swelling- 1 e) Age 3-14- 1 Age 15 – 44- 0 45 and above- -1 Cumulative Score ___________ Patients meeting the clinical criteria for pharyngitis, tonsillitis or Pharyngotonsillitis will be included in the study irrespective of the microbiological culture and antibacterial susceptibility results.
- •Note:  Throat swab will be obtained from all patients at the time of screening for culture and antibacterial susceptibility testing (as per standard method).
- •The specimen should be obtained from the posterior pharynx and/or the tonsillar pillars.
- •Patients with isolate(s) resistant to study medication or those who are found culture negative can be continued in the study if they show improvement clinically.
- •Their continuation in the study will be at the discretion of the investigator.
- •Patients with persistence or worsening in the signs and symptoms of infection after at least 3 doses of treatment with the study medication will be considered as clinical failures and will be withdrawn from the study.
- •Their further treatment will be at the discretion of the investigator.
- •The investigator may withdraw patient at any time during the course of the study if the same is in the best interest of the patient.
- •The symptoms MUST NOT be of more than 4 weeks duration.
- •Clinical Criteria: a.
- •Symptoms Patient with a diagnosis of acute bacterial sinusitis based on ATLEAST TWO of the following: Maxillary tooth pain Facial pain Frontal headache Purulent nasal discharge New onset fetor oris (bad breath) Morning cough Nasal obstruction b.
- •Signs A Patient should have ATLEAST ONE of the following signs: Purulent secretions from sinus ostia on examination Abnormal sinus transillumination Pain on palpation over sinuses Facial swelling Generalized sign and symptoms that are consistent with a diagnosis of acute bacterial sinusitis but are otherwise nonspecific include: Fever (temperature >38ºC/>100.4ºF) Malaise II.
- •Radiological Criteria: a.
- •Evidence of acute bacterial sinusitis on paranasal sinus X-ray with occipitomental view (water’s view)
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) [Note: Woman with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal].
- •[Note: Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
- •A male patient must agree to use adequate contraception from study entry till the last dose of the study medication.
排除标准
- •Subject will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
- •DISEASE SPECIFIC EXCLUSION CRITERIA 1.
- •Pharyngitis, Tonsillitis or Pharyngotonsillitis 1.1.
- •Patient who is a known carrier (note) of Streptococcus pyogenes based on medical history of the patient 1.1.
- •Patient with evidence of pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis 1.
- •Acute Bacterial Sinusitis: 1.2.
- •Patient with disease history consistent with allergic and other types of rhinitis 1.2.
- •Patient with isolated frontal and sphenoidal disease given the different pathophysiology and etiologic pathogens 1.2.
- •Patient with cystic fibrosis 1.2.
- •Immunocompromised patients or patients with other medical conditions that may affect interpretation of the effect and safety of trial drug 1.2.
- •Patient with history or current evidence of nasal polyposis
- •Patient with history of hypersensitivity to Cefpodoxime or other Cephalosporins, penicillin or any other β-lactam class of antibiotics or any of the excipients of the study formulation
- •Patient with history or current evidence of rheumatic or valvular heart disease or glomerulonephritis
- •Patient with evidence of 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.otitis media, or orbital/periorbital cellulitis)
- •Patient 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
- •Patient requiring hospitalization for treatment for upper respiratory tract infections
- •Patient requiring parenteral antimicrobial treatment for upper respiratory tract infections
- •Patient with any other concurrent infection that necessitates the use of additional systemic antimicrobial therapy.
- •Patient who had received antibiotic treatment for > 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented)
- •Patient with malabsorption syndrome or other gastrointestinal disease that could affect absorption of oral study medication
- •Patient with history of neoplasia or immunosuppression or on chronic immunosuppressive therapy.
- •Patient with history of HIV, Hepatitis B and HCV
- •Patient who is receiving concurrent treatment with diuretics, anticoagulants and corticosteroids
- •Patient with history of allergies e.g., hives, rashes etc.
- •Patient with significant disease(s) or disorder(s) other than the disease in consideration that in the opinion of the investigator may 15.
- •put the patient at risk because of participation in the study or 15.
- •interfere with the study evaluations or 15.
- •cause concern regarding patient’s ability to participate in the study
- •Pregnant women or breast feeding women
- •Patient with history of substance abuse as per Diagnostic and Statistical Manual (DSM-5) criteria
- •Patient who are unable or unwilling to comply with the study procedures
- •Patient who have participated in another investigational study within the last 3 months prior to screening
- •Investigators, study personnel, sponsor representatives and their first degree relatives Note- Carrier: Confirmed presence of the organism in their posterior pharynx, without any of the usual attendant clinical symptoms of acute pharyngitis.
结局指标
主要结局
Proportion of participants with adverse events and serious adverse events who have consumed at least one dose of the study medication
时间窗: 2 weeks
次要结局
- The efficacy will be evaluated based on clinical outcome at ‘Test of Cure’ visit: Clinically Evaluable-Modified Intention to Treat (CE-mITT) and Microbiologically Evaluable- Modified Intention to Treat (ME-mITT) in Pharyngitis/Tonsillitis/Pharyngotonsillitis and CE-mITT in Acute Bacterial Sinusitis patients.(2 weeks)
- The efficacy will be evaluated based on microbiological outcome at “Test of Cure†visit: Microbiologically Evaluable- Modified Intention to Treat (ME-mITT) in Pharyngitis/Tonsillitis/Pharyngotonsillitis patients.(2 weeks)
研究者
研究点 (10)
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