Study(clinical trial) to find out the usefulness of FILMARRAYâ?¢ Multiplex PCR gastro-intestinal panel stool test in the management of loose stools as compared to routine tests already in use.
- Conditions
- Health Condition 1: A00-A09- Intestinal infectious diseases
- Registration Number
- CTRI/2020/02/023150
- Lead Sponsor
- bioMerieux India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients of presumed infectious diarrhoea (3 or more loose stools in past 24 hours) who are between 18 to 99 years of age with availability of stool samples at GI syndrome onset and must have one of the 3 following features â?? 1. symptoms greater than 24 hours, 2. dehydration -defined as the need for intravenous fluid or as per clinician judgement (based on the general appearance and alertness of the patient, the pulse, the blood pressure, the presence or absence of postural hypotension, the mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and jugular venous pressure), and 3. signs of inflammation - defined as fever (greater than 101 F), blood in stool per patient, DRE, or tenesmus
Those with chronic Symptoms (greater than 14 days), those who are unable to follow- up (i.e. no telephone), those with likely non-infectious cause of diarrhea (Crohns disease, radiation colitis, irritable bowel syndrome, or celiac disease, those outpatients not requiring in hospital management and those cases where IDSA guidelines may not have been followed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the diagnostic yield (percentage positivity rates), days of antimicrobial usage, days of last unformed stools, length of hospital stay and rates of readmission/ recurrence of diarrhoea/ dysentery (by 30 day telephonic follow up ) in same cohort treated as guided by Multiplex PCR GI panel versus those treated as per conventional treatment.Timepoint: within 30 days
- Secondary Outcome Measures
Name Time Method To determine the regional etiological agents profile of inpatients presenting to AIIMS Rishikesh and to identify the demographic and other risk variables of the identified pathogens.Timepoint: at presentation