Safety of Antibiotic (Faropenem) in Pediatric Patients with Respiratory Tract Infections (RTIs), Or Urinary Tract Infection (UTI

Not Applicable

• Conditions: Health Condition 1: J988- Other specified respiratory disordersHealth Condition 2: N390- Urinary tract infection, site notspecified

• Registration Number: CTRI/2024/01/061255
• Lead Sponsor: Alkem Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with reported treatment-emergent adverse events (TEAE) and serious AEs (SAEs) from baseline to day 14. (A TEAE is defined as an AE that started occurring following the administration of the trial medicine)Timepoint: Baseline, day 7 and day 14

Secondary Outcome Measures

Name	Time	Method
1. Proportion of pediatric patients achieving clinical cure from baseline to day 7 & day 14 post treatment initiation (clinical cure is defined as complete resolution of clinical signs & symptoms according to Investigators judgement). <br/ ><br>2. Proportion of patients not achieving success based on symptoms deterioration or requiring change in antibiotic during the treatment phase. <br/ ><br>3. Proportion of patients achieving clinical improvement (resolution of majority of the symptoms in RTIs or UTI) at day 7 & day 14 & not requiring change in antibiotic during the treatment period. <br/ ><br>4. Proportion of patients with UTI observed to achieve bacteriological cure. (Bacteriological cure is defined as less than 1,000 cfu by ml as documented in the report (Urine culture) at study end.)Timepoint: Baseline, day 7 & day 14