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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.

FilmArrayâ?¢ multiplex PCR gastro-intestinal panel testing as a guide for management of infectious diarrhoea/ dysentery as compared to conventional management: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023150
Enrollment
74
Registered
2020-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A00-A09- Intestinal infectious diseases

Interventions

Intervention1: FilmArrayâ?¢ multiplex PCR gastro-intestinal panel, CBC, LFT, KFT, ABG: Based on the multiplex PCR system and tests for 22 of the most common bacteria, viruses and parasites causing inf

Sponsors

bioMerieux India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Prasan Kumar Panda

AIIMS, Rishikesh

prasan.med@aiimsrishikesh.edu.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026