| CTRI Number |
CTRI/2020/04/024681 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
07/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Access to diagnostic innovation essential for prevention of antimicrobial resistance |
|
Scientific Title of Study
|
Impact of improved diagnostic tools, practices,training and communication on acute fever case management and antibiotic prescriptions for children and adolescents presenting at outpatient facilities in the Community Clinics of ICMR-NICED, India
|
| Trial Acronym |
FIND |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shanta Dutta |
| Designation |
Director and Scientist G |
| Affiliation |
ICMR-NICED |
| Address |
P33 CIT ROAD SCHEME XM, BELIAGHATA
Kolkata
WEST BENGAL
700010
India |
| Phone |
913323633373 |
| Fax |
913323632398 |
| Email |
drshantadutta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanta Dutta |
| Designation |
Director and Scientist G |
| Affiliation |
ICMR-NICED |
| Address |
P33 CIT ROAD SCHEME XM, BEILAGHATA
Kolkata
WEST BENGAL
700010
India |
| Phone |
913323633373 |
| Fax |
913323632398 |
| Email |
drshantadutta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanta Dutta |
| Designation |
Director and Scientist G |
| Affiliation |
ICMR-NICED |
| Address |
P33 CIT ROAD SCHEME XM, BELIAGHATA
Kolkata
WEST BENGAL
700010
India |
| Phone |
913323633373 |
| Fax |
913323632398 |
| Email |
drshantadutta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Foundation for Innovative New Diagnostics |
|
|
Primary Sponsor
|
| Name |
Foundation for Innovative New Diagnostics FIND |
| Address |
Campus Biotech
Chemin des Mines 9
1202 Geneva
Switzerland.
|
| Type of Sponsor |
Other [Development, evaluation, and implementation of diagnostic tests for poverty-related diseases] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shanta Dutta |
ICMR- NICED |
DEPT. OF EPIDEMIOLOGY,
P/33 CIT ROAD, SCHEME XM, BELIAGHATA
Kolkata
WEST BENGAL |
913323633373
drshantadutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-NICED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Point of care diagnostic tests
2. Behavioural Intervention |
Trial Intervention is defined as (i) any diagnostic Point of care test (see below), (ii) diagnostic and clinical algorithm, (iii) clinic process flow, (iv) training and communication of healthcare workers and patients/caregivers.
Diagnostic Tests
The diagnostic tests to be used in the intervention package will be selected from the following:
Specific Point of Care (PoCs): List POC tests to be used here:
For All cases:
1. CBC
2. CRP
For Non Respiratory cases
3. Typhoid (Typhi Dot)
4. Dengue (NS1 & IgG / IgM)
5. Chikungunya (IgM)
6. Malaria (PV/PF Ag)
7. Scrub Typhus (RDT)
8. UTI (MULTISTIX)
For Respiratory cases
9. Group A streptococcus (RDT)
10. Strepto Pneumonae (RDT)
11. Influenza A and B (Rapid Strips)
12. RSV (RDT)
|
| Comparator Agent |
Standard Care of management |
patients will undergo prescribed laboratory tests based on provisional diagnosis and subsequent treatment given based on results as it is done routinely as per the national guidelines and standard treatment protocol. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
A. Patients with fever with no focus / RTI:
a. Children (6 months to <14years) and adolescents (14 years to less than 18 years old) of both sexes.
b. Presenting with an acute febrile illness defined as temperature of >37.5°C (oral) or history of fever within the last 7 days with no focus or suspected RTI.
c. Parent/guardian providing written informed consent for their children aged less than 18 years of age.
d. Obtain assent for adolescent between 12 and less than 18 years old
e. Willing to provide blood (as well as urine, NP or throat swab if required) samples and adhere to study procedures explained in the consent forms following the protocol.
f. Available and willing to return for follow-up visit at the health facility.
B. Training and communication (for those randomised to intervention arm):
a. Parent/guardian providing informed consent to participate in the training and communication component of the study. The same informed consent form will cover both populations adult caregivers and adolescents
b. Clinic staff who have provided written informed consent to participate in the training and communication as per randomisation protocol
|
|
| ExclusionCriteria |
| Details |
Participants are excluded using the following exclusion criteria:
o Children and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
o Patients with acute febrile illness outside the allowed age range.
o Severely ill patients requiring hospital admission or referral as assessed by the study clinicians.
o Anyone refusing consent to the study or not available for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Measure and compare proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
2. Measure and compare rates of antibiotic prescriptions for acute febrile illness in the clinic
|
After 12 months of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adherence to new algorithm by health care workers.
2. Adherence to prescription by patients/caregivers.
3. Rates of adverse events
|
After 12 months of recruitment |
|
|
Target Sample Size
|
Total Sample Size="1760"
Sample Size from India="1760"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A ‘just-in-case’ antibiotics prescription practice is one of the causes of both antimicrobial resistance (AMR) and inadequate management of acute febrile illnesses, both resulting in increased morbidity and mortality. At the same time, many patients who would require antibiotic treatment do not get it. An adaptation in current practice needs to occur to improve case management in LMICs. Success will mean making significant steps toward achieving the dual goal of tackling AMR and providing universal health coverage (UHC). Here the PICO question addressed is: 1. In children and adolescents presenting to outpatient clinics / peripheral health centres in LMICs with acute febrile illness / Respiratory Tract Infection (Population), 2. by combining available diagnostic tests plus algorithms plus clinic process flow plus training and communication for care-givers and users (Intervention) 3. over current practice (Control) can we improve patients management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotic prescriptions as appropriate and feasible (Outcome)?
The main objective is to compare the impact of a package of interventions (diagnostic tests plus algorithms plus clinic process flow plus training and communication for care-givers and users) on clinical outcomes and antibiotic prescriptions, with standard-of-care practices, in children and adolescents presenting with acute febrile illnesses (defined as fever with no focus or Respiratory Tract Infection lasting for no more than 7 days), at outpatient clinics in India. The intended outcomes are:
1. Measurement and comparison of proportion of outpatient cases of acute febrile illness with favorable outcome (defined as being alive and asymptomatic) and,
2. Measurement and comparison of rates of antibiotic prescription fro acute febrile illness in the clinics as well. |