Acute Febrile IllnessAcceleratorNCT04081051
Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention
A study testing diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions) in people with Acute Febrile Illness, run by Foundation for Innovative New Diagnostics, Switzerland at 8 sites in 5 countries.
Trial summary
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in… Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Acute Febrile Illness
- What is being tested?
- diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,294 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 31 Aug 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 >37.5°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).
Who cannot join
- 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).
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
India4 sites
National Institute of Cholera & Enteric Diseases
Beliaghata, Kolkata, 700010
Post Graduate Insitute Medical Education and Research
Chandigarh, 160012
Jan Swathya Sahyog
Ganiyari, Chhattisgarh, 495112
R D Gardi Medical College
Ujjain, Madhya Pradesh, 456006
Burkina Faso1 site
IRSS-DRCO/Clinical Research Unit of Nanoro (CRUN)
Nanoro, BP 218
About this study
Official title: Impact of Improved Diagnostic Tools, Training and Communication on Acute Fever Case Management and Antibiotic Prescriptions for Children and Adolescents Presenting at Outpatient Facilities in Lower & Middle-Income Countries.
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) 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. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
Read the detailed 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: 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)
- To improve the management of acute febrile illness
- To promote rational and targeted use of antibiotics for acute febrile illness
- To determine the aetiology of fever in patients presenting to outpatient facilities using available PoC diagnostic tests
- To study the safety and feasibility of a package of interventions compared to current practice of care
- To assess the effectiveness of training and communication tools to adherence to the prescribed treatment
Primary endpoints
- Proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
- antibiotic prescriptions rates for acute febrile illness in the clinic Secondary endpoints (outcomes) 1. Duration of time spent in the clinic
- 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
- Acute Febrile Illness
- Being tested
- diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)Other
Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Diagnostic algorithm( paper and electronic) utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change training for healthcare workers Receives: Other: diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions) |
| control | No intervention | Standard of care practices for acute febrile illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of acute febrile cases with favorable clinical outcomes at day 7
Favorable defined as being alive and asymptomatic.
Measured: Day 7
Antibiotic prescription rates in acute fever cases
Proportion of antibiotic prescriptions for acute febrile illness in the clinic
Measured: Day 0
Secondary outcomes (4)
Proportion of participants with acute fever Diagnoses identified by point of care tests.
Proportion of patients with disease specific diagnosis identified by PoC tests
Measured: Day 0
Adverse events
Frequency of adverse events within 7 days of recruitment
Measured: Day 7
Time spent in the clinic
Time spent in the clinic
Measured: Day 0
Proportion of study participants who adhered to antibiotic prescriptions
Adherence to antibiotic prescriptions
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start31 Aug 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Febrile IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Indian Council of Medical Research, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Piero Olliaro, MD, Study director, Foundation for Innovative New Diagnostics (FIND)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081051
- Sponsor's protocol ID
- AM 001
- Acronym
- Accelerator
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to be discussed
Publications
Kaur M, Kumar D, Horgan P, Taneja N, Gahlot S, Kaur T, Tomar A, Singh S. Training and Communication Package for Acute Fever Case Management and Antibiotic Prescriptions: A Qualitative Exploration into Changing Behaviors of Healthcare Workers, Patients, and Caregivers in Chandigarh, India. Indian J Public Health. 2026 Apr 1;70(2):169-176. doi: 10.4103/ijph.ijph_482_25. Epub 2026 Jun 19.
PubMed 42330228Kiemde 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.
PubMed 39192209Adjei 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.
PubMed 37490745Kiemde 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.
PubMed 37490742Compaore 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.
PubMed 37490738Salami 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.
PubMed 33239106
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Improved Diagnostic Tools, Training and Communication on Acute Fever Case Management and Antibiotic Prescriptions for Children and Adolescents Presenting at Outpatient Facilities in Lower & Middle-Income Countries.
- ClinicalTrials.gov ID
- NCT04081051
- Acronym / sponsor ID
- Accelerator / AM 001
- Conditions
- Acute Febrile Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,294 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Oxford, Indian Council of Medical Research, World Health Organization
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) 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. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
Detailed 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: 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)
- To improve the management of acute febrile illness
- To promote rational and targeted use of antibiotics for acute febrile illness
- To determine the aetiology of fever in patients presenting to outpatient facilities using available PoC diagnostic tests
- To study the safety and feasibility of a package of interventions compared to current practice of care
- To assess the effectiveness of training and communication tools to adherence to the prescribed treatment
Primary endpoints
- Proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
- antibiotic prescriptions rates for acute febrile illness in the clinic Secondary endpoints (outcomes) 1. Duration of time spent in the clinic
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)Diagnostic algorithm( paper and electronic) utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change training for healthcare workers |
| control | No intervention | –Standard of care practices for acute febrile illness |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients presenting with fever with no focus/RTI:
Key exclusion criteria (4 listed)
- o Children and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention |
Primary outcome
Proportion of acute febrile cases with favorable clinical outcomes at day 7
Time frame: Day 7
Favorable defined as being alive and asymptomatic.
Antibiotic prescription rates in acute fever cases
Time frame: Day 0
Proportion of antibiotic prescriptions for acute febrile illness in the clinic
4 secondary outcomes
Proportion of participants with acute fever Diagnoses identified by point of care tests.
Time frame: Day 0
Adverse events
Time frame: Day 7
Time spent in the clinic
Time frame: Day 0
Proportion of study participants who adhered to antibiotic prescriptions
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 42330228Kaur M, Kumar D, Horgan P, Taneja N, Gahlot S, Kaur T, Tomar A, Singh S. Training and Communication Package for Acute Fever Case Management and Antibiotic Prescriptions: A Qualitative Exploration into Changing Behaviors of Healthcare Workers, Patients, and Caregivers in Chandigarh, India. Indian J Public Health. 2026 Apr 1;70(2):169-176. doi: 10.4103/ijph.ijph_482_25. Epub 2026 Jun 19.
- Derived from this study: PubMed 39192209Kiemde 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.
- Derived from this study: PubMed 37490745Adjei 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.
- Derived from this study: PubMed 37490742Kiemde 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.
- Derived from this study: PubMed 37490738Compaore 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.
- Derived from this study: PubMed 33239106Salami 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.
- Individual participant dataSharing planned: No. to be discussed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piero Olliaro, MD study director
Foundation for Innovative New Diagnostics (FIND)
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions) in people with Acute Febrile Illness, run by Foundation for Innovative New Diagnostics, Switzerland at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India, Burkina Faso, Ghana, Nepal, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of acute febrile cases with favorable clinical outcomes at day 7 (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081051, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.