CTRI/2024/01/061255
Not yet recruiting
未知
A Prospective, Observational, Multicentric Study to Evaluate Safety and Efficacy of Faropenem inPediatric Patients with Respiratory Tract Infections (RTIs), Or Urinary Tract Infection (UTI) - NI
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: N390- Urinary tract infection, site notspecified
- Sponsor
- Alkem Laboratories Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients of either gender, aged greater than equal to 6 months and \<18 years
- •2\. Subjects clinically diagnosed with RTIs or UTI A. Diagnosis of CABP / Acute bronchitis confirmed if the following criterias are present: a.History of fever (oral temperature \>38°C or axillary temperature \>37\.5°C) or hypothermia (oral temperature \<35°C or axillary temperature \<34\.5°C). b. Acute onset or worsening of at least two of the following within past (5 days of enrolment): I) tachycardia ( \>6 months to \<24 months: \>160 beats/min; greater than equal to 24 months to \<10 years: \>140 beats/min; greater than equal to 10 years: \>100 beats/min), II) tachypnea ( \>6 months to \<12 months: \>50 breaths/min; greater than equal to 12 months to \<5 years: \>40 breaths/min; greater than equal to 5 years: \>20 breaths/min), III) Cough, dyspnea, grunting, sputum production, chest pain, cyanosis, increased work of breathing, c. At least one of the following hematology findings (if available in clinical and medical records): leukocytosis ( \>15,000 WBC/mm3\), \>15% immature neutrophils (bands), leukopenia. B. Diagnosis of ABRS confirmed based on the following: a. Inflammation nasal mucosa, purulent/mucopurulent nasal or postnasal discharge, or pathological shadow in the paranasal sinus on a radiogram b. Total score of the following symptoms greater than equal to 4 (suggestive of moderate or severe ABRS): I) rhinorrhea (none: 0, mild/small amount: 1, moderate or severe: 2\); II) bad mood/productive cough (none: 0, mild/small amount: 1, moderate or severe: 2\); III)nasal/postnasal discharge \[none: 0 (serous), mild/small amount: 1 (mucopurulent, small amount), moderate or severe: 2 (moderate or larger amount)] C. Diagnosis of UTI confirmed based on urine culture (colony count greater than equal to 105 CFU/ml) or Urine R/M if available.D. Diagnosis of Pharyngitis and Tonsillitis based on clinical diagnosis of mild to moderate upper respiratory tract infection (pharyngitis or tonsillitis or tonsillo\-pharyngitis) calculated as per modified Centor score (McIsaac score14\) greater than equal to 3 during the screening period. MacIsaac score parameter: a) Body Temperature greater than equal to 37\.5 degree C (axillary)\- 1, b) Absence of cough\- 1, c) Swollen, tender anteriorcervical nodes\- 1, d) Tonsillar exudate or swelling\- 1,e) Age 3\-14 years\- 1,Age 15\-44 years\- 0, 45 years and above \-(\-1\).Cumulative Score\#, \# Not appropriate to patients who are younger than 3 years old. According to the investigators discretion, patients under the age of 3 will be evaluated. E. Patients and patient’s LAR willing to provide consent and assent (Applicable for age group of 7 to \<18\) for study participation.
Exclusion Criteria
- •1\. Severe cases of CABP including hypoxemic or septic as per Investigators judgement.
- •2\. Evidence of infectious mononucleosis clinically, leukopenia and/or thrombocytopenia, or diarrhoea at the time of screening (If available in clinical and medical records)
- •3\. Receiving or has received more than one dose of systemic antibiotic or medication (within 72 hours prior to enrolment) affecting bowel movement.
- •4\. Any condition (epilepsy or cardiovascular disease etc) or concomitant medication, that in the opinion of the investigator, might affect study outcome
- •5\. Any condition in the patient, that in the opinion of the investigator, might worsen upon participation in the study
- •6\. Known allergy or hypersensitivity to the components of the study medication
- •7\. Participation in another clinical trial within past 30 days
Outcomes
Primary Outcomes
Not specified
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