Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    10000
  • sponsor
    Foundation for Innovative New Diagnostics, Switzerland
Updated on 21 April 2021

Summary

This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries.

Description

Background and rationale. 'Just-in-case' antibiotic prescribing practices is one of the causes of inadequate management of 'acute febrile illnesses' and AMR in Low- and Middle-income Countries (LMICs). At the same time, some people who would require antibiotic treatment do not get it. An improvement in case management and prescription practice might lead to a decrease in morbidity and mortality. Success will mean making significant steps toward achieving the dual goal of improving UHC and tackling AMR.

The PICO question addressed is:

  1. Population; patients (children/ adolescent and adult) presenting to outpatient clinics / peripheral health centres in LMICs with acute febrile illness / Respiratory Tract Infection
  2. Intervention; combining available diagnostic tests, diagnostic aids/algorithms, clinic process flow and, training and communication
  3. Control; Compared to current practice
  4. Outcome; can we improve management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotic prescriptions as appropriate and feasible Primary objective(s) To evaluate the impact of a package of interventions (point of care [PoC] tests, clinical algorithm, clinic process flow, training and communication tools) 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 Secondary objective(s)
  5. To improve the management of acute febrile illness 2. To promote rational and targeted use of antibiotics for acute febrile illness 3. To determine the aetiology of fever in patients presenting to outpatient facilities using available PoC diagnostic tests 4. To study the safety and feasibility of a package of interventions compared to current practice of care 5. To assess the effectiveness of training and communication tools to adherence to the prescribed treatment Primary endpoints (outcomes) 1. Proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
  6. antibiotic prescriptions rates for acute febrile illness in the clinic Secondary endpoints (outcomes) 1. Duration of time spent in the clinic 2. Proportion of patients treated for specific bacterial infection 3. Proportion of patients with disease specific diagnosis identified by PoC tests 4. Frequency of serious adverse event (SAE) within 7 days of recruitment 5. Frequency of unscheduled (unplanned) visit within 7 days of recruitment 6. Training and communication package uptake 7. Proportion of patients prescribed antibiotic at clinic who reported adherence to prescription on day 7 8. Proportion of patients who were not prescribed antibiotics at clinic who received antibiotics elsewhere between day 0 and day 7
  7. Behaviour Change Intervention Recommendations Trial design A multi-centre, open label, two arm, randomized-controlled trial Trial sites/setting This study will be conducted in outpatient departments and primary care clinics in Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda.

Trial population . The study population will consist of children, adolescents and adults presenting to the health care facility, or provider, with acute fever or history of fever

Sample Size Approx. 10,000

Details
Condition Acute Febrile Illness
Treatment diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
Clinical Study IdentifierNCT04081051
SponsorFoundation for Innovative New Diagnostics, Switzerland
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients presenting with fever with no focus/RTI
Children (6 months to <12 years) and adolescents (12 years to less than 18 years old) of both sexes
Presenting with an acute febrile illness defined as temperature of >37.5C or history of fever within the last 7 days with no focus or suspected RTI
Parent/guardian providing written informed consent for their children if less than 18 years of age
Obtain assent for adolescent between 12 and less than 18 years old
Willing to provide blood and other samples and adhere to study procedures explained in the consent forms following the protocol
Available and willing to return for follow-up visit at the health facility on day 7 (+/- 2 days)

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)
Patients with acute febrile illness outside the allowed age range for the site
Severely ill patients requiring hospital admission or referral as assessed by the study clinicians
Anyone refusing consent to the study or not able to attend the health centre for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note