InfectionNCT02697513
The 'Bekele Afessa Scan-Teach-Treat Approach'
A study testing simple infection management protocol in people with Infection and Sepsis, run by University of Salzburg.
Trial summary
Infection and sepsis are among the leading causes of death worldwide, particularly in middle- and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. Read more about this study
- Who is it for?
- Ages 4 weeks and older
- What is being tested?
- simple infection management protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,594 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- 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 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients admitted to Gitwe Hospital because of a suspected or confirmed acute infectious disease
Who cannot join
- age <28 days of life
- known allergy to any study-related drug
- limited therapy due to terminal disease
- refusal of written informed consent
About this study
Official title: The 'Bekele Afessa Scan-Teach-Treat Approach' to Improve Care of Patients With Acute Infection at the Gitwe Hospital in Gitwe/Rwanda
Infection and sepsis are among the leading causes of death worldwide, particularly in middle- and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. In this prospective before-after study, three interventions will be performed: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures).
Read the detailed description
Infection and sepsis are among the leading causes of death worldwide. The annual burden of infectious diseases is particularly high in middle- and low-income countries. The Surviving Sepsis Campaign released guidelines for severe sepsis and septic shock management, whose implementation improved sepsis outcomes. Despite these benefits, the Surviving Sepsis Campaign cannot be implemented in middle- or low-income countries due to lack of training and resources. This leaves those clinicians caring for the worldwide majority of patients suffering from acute infection without standardized and adoptable guidance for sepsis. The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. This approach consists of the following three steps: Step 1 - scanning the region of interest for key elements of regional epidemiology of acute infectious diseases as well as elements of the teach and treat module; Step 2 - implementing a focused training program on the management of acute infectious diseases; Step 3 - implementing a 'Sepsis First Aid kit' into clinical practice.
In this prospective before-after study, this approach will be piloted at the Gitwe Distict Hospital in Gitwe, rural Rwanda. During three four month periods, three interventions are planned: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures). In addition to the main analysis, study endpoints will be analyzed separately for the following á priori defined sub-groups: children (<15 years); patients with malaria; patients positive for HIV; patients referred to from primary health care centers.
- Being tested
- simple infection management protocol
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple infection management protocolBehavioural
Implementation of a simple management protocol to improve care of patients with acute infection. Implementation will be assisted by a 1.5-day focused training program.
| Study group | Role | What they receive |
|---|---|---|
| Before Period | No intervention | Collection of patient-related data without interventions being made |
| After Period | Active comparator | Implementation of a simple infection management protocol as well as a 'Sepsis First Aid' kit to assist in the management of patients with acute infection Receives: Behavioral: simple infection management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of evidence-based interventions performed in study patients during six hours after hospital admission before and after the focused training program and implementation of the clinical management protocol.
Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Measured: Six hours after hospital admission
Secondary outcomes (7)
Prevalence of sepsis
Measured: 72 hours after hospital admission
Hospital mortality
Measured: 28 days after hospital admission or at hospital discharge
Time to initiation of evidence-based interventions after Hospital admission
Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Measured: Six hours after hospital admission
Rate of evidence-based interventions initiated before hospital admission in study patients referred to from regional dispensaries
Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Measured: baseline
Rate of pre-defined adverse events
Measured: Twenty-four hours after hospital admission
Rate of evidence-based interventions performed during the first 6 hours after hospital admission before and after the implementation of a 'Sepsis First Aid' kit
Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
Measured: Six hours after hospital admission
Rate of correct answers of a test on knowledge about acute infectious diseases before and after the focused educational training
Measured: 1 hour before and 1 hour after the focused educational training course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,594 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Gitwe Hospital and Gitwe School of Medicine, Mayo Clinic, Surviving Sepsis Campaign, University of Nebraska Medical
- Responsible party
- Principal investigator, Martin W Duenser, MD, DESA, EDIC, University of Salzburg
- Investigators
- Chris Farmer, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697513
- Sponsor's protocol ID
- V01
- Status last verified
- Apr 2017
- First submitted
- 14 Feb 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing Evidence-Based Interventions in Patients with Acute Infections in a Resource-Limited Setting: A Before-and-After Feasibility Trial in Gitwe, Rwanda. Crit Care Med. 2018 Aug;46(8):1357-1366. doi: 10.1097/CCM.0000000000003227.
PubMed 29957715Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing evidence-based interventions in patients with acute infections in a resource-limited setting: a before-and-after feasibility trial in Gitwe, Rwanda. Intensive Care Med. 2018 Sep;44(9):1436-1446. doi: 10.1007/s00134-018-5266-x. Epub 2018 Jun 28.
PubMed 29955924
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'Bekele Afessa Scan-Teach-Treat Approach' to Improve Care of Patients With Acute Infection at the Gitwe Hospital in Gitwe/Rwanda
- ClinicalTrials.gov ID
- NCT02697513
- Acronym / sponsor ID
- V01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,594 participants (actual)
- Lead sponsor
- University of SalzburgUniversity, hospital or other
- Collaborators
- Gitwe Hospital and Gitwe School of Medicine, Mayo Clinic, Surviving Sepsis Campaign, University of Nebraska Medical
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Infection and sepsis are among the leading causes of death worldwide, particularly in middle- and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. In this prospective before-after study, three interventions will be performed: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures).
Detailed description
Infection and sepsis are among the leading causes of death worldwide. The annual burden of infectious diseases is particularly high in middle- and low-income countries. The Surviving Sepsis Campaign released guidelines for severe sepsis and septic shock management, whose implementation improved sepsis outcomes. Despite these benefits, the Surviving Sepsis Campaign cannot be implemented in middle- or low-income countries due to lack of training and resources. This leaves those clinicians caring for the worldwide majority of patients suffering from acute infection without standardized and adoptable guidance for sepsis. The Surviving Sepsis Campaign has launched an initiative to improve sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. This approach consists of the following three steps: Step 1 - scanning the region of interest for key elements of regional epidemiology of acute infectious diseases as well as elements of the teach and treat module; Step 2 - implementing a focused training program on the management of acute infectious diseases; Step 3 - implementing a 'Sepsis First Aid kit' into clinical practice.
In this prospective before-after study, this approach will be piloted at the Gitwe Distict Hospital in Gitwe, rural Rwanda. During three four month periods, three interventions are planned: First four months period: collection of baseline data on the clinical management of patients with acute infection. Second four months period: During the first days, a 1.5-day focused training program will be performed (participants: health care workers of primary care facilities within the catchment area of the Gitwe hospital and health care workers of the Gitwe hospital). Then, a simple management protocol to care for patients with an acute infection will be implemented into clinical practice. During the third four months period, a 'Sepsis First Aid' kit containing essential resources to treat patients with an acute infection (antimicrobials, fluids, data documentation sheet) will be distributed to primary care facilities and the emergency department of the Gitwe hospital. During the 8 months following the focused training program (periods 2 and 3), data collection will continue. It is hypothesized that implementation of a simple clinical management protocol and exposure of health care workers in the Gitwe Hospital area to a focused training program on the management of acute infections will increase the rate of evidence-based interventions performed in patients with an acute infection during the first six hours after hospital admission (administration of oxygen and fluids whenever indicated, timely administration of antimicrobial drugs, source control measures). In addition to the main analysis, study endpoints will be analyzed separately for the following á priori defined sub-groups: children (<15 years); patients with malaria; patients positive for HIV; patients referred to from primary health care centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Period | No intervention | –Collection of patient-related data without interventions being made |
| After Period | Active comparator | Behavioral: simple infection management protocolImplementation of a simple infection management protocol as well as a 'Sepsis First Aid' kit to assist in the management of patients with acute infection |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted to Gitwe Hospital because of a suspected or confirmed acute infectious disease
Key exclusion criteria (4 listed)
- age <28 days of life
- known allergy to any study-related drug
- limited therapy due to terminal disease
- refusal of written informed consent
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 |
|---|---|---|
| simple infection management protocolImplementation of a simple management protocol to improve care of patients with acute infection. Implementation will be assisted by a 1.5-day focused training program. | Behavioural | After Period |
Primary outcome
Rate of evidence-based interventions performed in study patients during six hours after hospital admission before and after the focused training program and implementation of the clinical management protocol.
Time frame: Six hours after hospital admission
Evidenced based interventions are defined as initiation of antimicrobials, surgical source control (if applicable), oxygen administration (in case of respiratory distress) and fluid resuscitation (in case of tissue hypoperfusion)
7 secondary outcomes
Prevalence of sepsis
Time frame: 72 hours after hospital admission
Hospital mortality
Time frame: 28 days after hospital admission or at hospital discharge
Time to initiation of evidence-based interventions after Hospital admission
Time frame: Six hours after hospital admission
Rate of evidence-based interventions initiated before hospital admission in study patients referred to from regional dispensaries
Time frame: baseline
Rate of pre-defined adverse events
Time frame: Twenty-four hours after hospital admission
Rate of evidence-based interventions performed during the first 6 hours after hospital admission before and after the implementation of a 'Sepsis First Aid' kit
Time frame: Six hours after hospital admission
Rate of correct answers of a test on knowledge about acute infectious diseases before and after the focused educational training
Time frame: 1 hour before and 1 hour after the focused educational training course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Derived from this study: PubMed 29957715Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing Evidence-Based Interventions in Patients with Acute Infections in a Resource-Limited Setting: A Before-and-After Feasibility Trial in Gitwe, Rwanda. Crit Care Med. 2018 Aug;46(8):1357-1366. doi: 10.1097/CCM.0000000000003227.
- Derived from this study: PubMed 29955924Urayeneza O, Mujyarugamba P, Rukemba Z, Nyiringabo V, Ntihinyurwa P, Baelani JI, Kwizera A, Bagenda D, Mer M, Musa N, Hoffman JT, Mudgapalli A, Porter AM, Kissoon N, Ulmer H, Harmon LA, Farmer JC, Dunser MW, Patterson AJ; Sepsis in Resource-Limited Nations Workgroup of the Surviving Sepsis Campaign. Increasing evidence-based interventions in patients with acute infections in a resource-limited setting: a before-and-after feasibility trial in Gitwe, Rwanda. Intensive Care Med. 2018 Sep;44(9):1436-1446. doi: 10.1007/s00134-018-5266-x. Epub 2018 Jun 28.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Chris Farmer, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing simple infection management protocol in people with Infection and Sepsis, run by University of Salzburg.
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 1 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: status not confirmed, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Rate of evidence-based interventions performed in study patients during six hours after hospital admission before and after the focused training program and implementation of the clinical management protocol. (time frame: Six hours after hospital admission). 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 NCT02697513, which also lists 2 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 1 May 2017.