Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention
NCT ID: NCT04081051
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17294 participants
INTERVENTIONAL
2020-08-31
2022-09-30
Brief Summary
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Detailed Description
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The PICO question addressed is: in children/ adolescents and adults (Population) presenting to outpatient clinics / peripheral health centres in LMICs with acute febrile illness/Respiratory Tract Infection can a combination of available PoC rapid diagnostic tests, diagnostic aids/algorithms, clinic process flow and, training and communication (Intervention) improve management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotic prescriptions (Outcomes) compared to current practice (Control)?
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)
1. 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
1. Proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
2. 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 9. Behaviour Change Intervention Recommendations
Trial design: A multi-centre, open label, two arm, randomized-controlled trial
Trial sites: This study will be conducted in outpatient departments and primary care clinics in Burkina Faso, Ghana, India, 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: 19,922
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Intervention
Diagnostic algorithm( paper and electronic) utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change training for healthcare workers
diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers
control
Standard of care practices for acute febrile illness
No interventions assigned to this group
Interventions
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diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers
Eligibility Criteria
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Inclusion Criteria
* 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 \>37.5°C 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
* 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).
6 Months
65 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Indian Council of Medical Research
OTHER_GOV
WHO, Special Programme for Research and Training in Tropical Diseases (TDR)
UNKNOWN
Foundation for Innovative New Diagnostics, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Piero Olliaro, MD
Role: STUDY_DIRECTOR
Foundation for Innovative New Diagnostics (FIND)
Locations
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IRSS-DRCO/Clinical Research Unit of Nanoro (CRUN)
Nanoro, , Burkina Faso
Shai-Osudoku District Hospital
Accra, Dodowa, Ghana
Jan Swathya Sahyog
Ganiyari, Chhattisgarh, India
National Institute of Cholera & Enteric Diseases
Beliaghata, Kolkata, India
R D Gardi Medical College
Ujjain, Madhya Pradesh, India
Post Graduate Insitute Medical Education and Research
Chandigarh, , India
Patan Academy of Health Sciences
Lalitpur, Lagankhel, Nepal
Infectious Disease research collaboration
Kampala, , Uganda
Countries
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References
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Kiemde F, Nkeramahame J, Ibarz AB, Dittrich S, Olliaro P, Valia D, Rouamba T, Kabore B, Kone AN, Sawadogo S, Bere AW, Some DY, Some AM, Compaore A, Horgan P, Weber S, Keller T, Tinto H. Impact of a package of point-of-care diagnostic tests, a clinical diagnostic algorithm and adherence training on antibiotic prescriptions for the management of non-severe acute febrile illness in primary health facilities during the COVID-19 pandemic in Burkina Faso. BMC Infect Dis. 2024 Aug 27;24(1):870. doi: 10.1186/s12879-024-09787-y.
Adjei A, Kukula V, Narh CT, Odopey S, Arthur E, Odonkor G, Mensah MM, Olliaro P, Horgan P, Dittrich S, Moore CE, Salami O, Awini E, Nkeramahame J, Williams J, Baiden R. Impact of Point-of-Care Rapid Diagnostic Tests on Antibiotic Prescription Among Patients Aged <18 Years in Primary Healthcare Settings in 2 Peri-Urban Districts in Ghana: Randomized Controlled Trial Results. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S145-S155. doi: 10.1093/cid/ciad328.
Kiemde F, Valia D, Kabore B, Rouamba T, Kone AN, Sawadogo S, Compaore A, Salami O, Horgan P, Moore CE, Dittrich S, Nkeramahame J, Olliaro P, Tinto H. A Randomized Trial to Assess the Impact of a Package of Diagnostic Tools and Diagnostic Algorithm on Antibiotic Prescriptions for the Management of Febrile Illnesses Among Children and Adolescents in Primary Health Facilities in Burkina Faso. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S134-S144. doi: 10.1093/cid/ciad331.
Compaore A, Ekusai-Sebatta D, Kaawa-Mafigiri D, Kukula V, Odopey S, Kapisi J, Hopkins H, Kiemde F, Tinto H, Baiden R, Olliaro P, Nkeramahame J, Dittrich S, Horgan P; ADIP study group. Viewpoint: Antimicrobial Resistance Diagnostics Use Accelerator: Qualitative Research on Adherence to Prescriptions. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S206-S210. doi: 10.1093/cid/ciad323.
Salami O, Horgan P, Moore CE, Giri A, Sserwanga A, Pathak A, Basnyat B, Kiemde F, Smithuis F, Kitutu F, Phutke G, Tinto H, Hopkins H, Kapisi J, Swe MMM, Taneja N, Baiden R, Dutta S, Compaore A, Kaawa-Mafigiri D, Hussein R, Shakya SU, Kukula V, Ongarello S, Tomar A, Chadha SS, Walia K, Kelly-Cirino C, Olliaro P. Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial. Trials. 2020 Nov 25;21(1):974. doi: 10.1186/s13063-020-04897-9.
Other Identifiers
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AM 001
Identifier Type: -
Identifier Source: org_study_id