Escherichia Coli BacteremiaSOABNCT04146922
Switch to Oral Antibiotics in Gram-negative Bacteremia
A study testing Step down to oral antimicrobial therapy and IV antimicrobial therapy in people with Escherichia Coli Bacteremia and Klebsiella Bacteraemia, run by Hamad Medical Corporation at 7 sites in 4 countries.
Trial summary
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Escherichia Coli Bacteremia, Klebsiella Bacteraemia, Enterobacter Bacteraemia
- What is being tested?
- Step down to oral antimicrobial therapy and IV antimicrobial therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 13 Oct 2019to 30 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Mono-microbial blood stream infection.
- Isolation of E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species from ≥1 blood culture(s).
- Adequate source control within ≤5 days of staring in-vitro active intravenous antimicrobial therapy.
- Afebrile (Tmax <38 degrees Celsius) for ≥48 hours.
- Hemodynamically stable for ≥48 hours (SBP ≥100 mmHg, no vasopressors).
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- Microbiologically active intravenous therapy for 3-5 days.
- Bloodstreams isolate in-vitro susceptibility to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole.
- Ability to take oral medication directly or through a feeding tube.
Who cannot join
- Allergy to all in-vitro active antibiotics which are available in oral formulations.
- Pregnancy.
- Infective endocarditis.
- Central nervous system infection.
- Terminal illness with expected survival <14 days.
- Neutropenia (absolute neutrophil count <1.0x10^9/L).
- Hematopoietic or solid organ transplantation within the preceding 90 days.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Turkey (Türkiye)4 sites
Istanbul Medipol University
Istanbul
Istanbul University Carrahpasa Medical School
Istanbul
Marmara University School of Medicine
Istanbul
Ordu University School of Medicine
Ordu
About this study
Official title: Switch to Oral Antibiotics in Gram-negative Bacteremia (SOAB); a Randomized, Open-label, Clinical Trial.
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1,000/ml and hematopoietic or solid organ transplantation within the preceding 90 days. Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary outcome is treatment failure at 90-days with 10% margin for non-inferiority in the 95% confidence interval around the difference in outcome between the two study groups.
Read the detailed description
Oral antimicrobial therapy mitigates vascular line associated complications such as infection, thrombosis and pain, facilitating early mobilization and discharge and reducing healthcare costs. Efficacy and safety of step-down to oral antimicrobial therapy in patients with Enterobacteriaceae bacteremia has never been confirmed in a randomized clinical trial. The aim of this clinical trial is to evaluate the safety and efficacy of oral step down strategy in patients with Gram-negative blood stream infections.
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1.0x109/L and hematopoietic or solid organ transplantation within the preceding 90 days.
The primary endpoint is treatment failure at 90-days, defined as a composite of the death from any cause, need for additional antimicrobial therapy with one or more microbiologically active agents before complete resolution of signs and symptoms of infection, microbiological relapse (same species from any clinical site) and infection-related re-admission.
Eligible subjects will be randomized using permuted blocks of variable sizes to full intravenous antimicrobial therapy course (IV Group) or intravenous followed by step-down to oral therapy (PO Group). Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary analysis will include all patients who were randomized and received at least one dose of the assigned treatment. The difference in primary outcome rate between the intervention and control groups will be presented alongside a 95% confidence interval (CI), adjusted by source of bacteremia. If the upper limit of the 95% CI for the difference in overall response is below 10%, non-inferiority will be concluded.
A Data and Safety Monitoring Board will oversee the trial. An interim analysis will be performed after the first 50% of the target sample have completed the 90-day study period. The Data and Safety Monitoring Board can make a binding recommendation to terminate the study if the results of the interim analysis indicate very high likelihood for positive effect or futility.
- Conditions
- Escherichia Coli Bacteremia, Klebsiella Bacteraemia, Enterobacter Bacteraemia, Serratia Bacteraemia, Citrobacter Bacteraemia, Proteus Bacteraemia
- Being tested
- Step down to oral antimicrobial therapy, IV antimicrobial therapy
- Keywords
- Enterobacteriaceae, bacteremia, step down oral therapy
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step down to oral antimicrobial therapyOther
Step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.
IV antimicrobial therapyOther
No step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| IV Group | Active comparator | Eligible patients randomized to complete their antimicrobial therapy course through intravenous (IV) administration. Receives: Other: IV antimicrobial therapy |
| Oral Group | Experimental | Eligible patients randomized to step down to oral antimicrobial therapy for the remainder of their treatment course. Receives: Other: Step down to oral antimicrobial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure.
Defined as death, need for additional active antibiotic therapy before resolution of all signs and symptoms of infection, microbiological relapse or infection-related re-admission within 90 days of commencement of active intravenous antimicrobial therapy.
Measured: 90 days
Secondary outcomes (5)
Death from any cause.
Death from any cause during follow up period.
Measured: 90 days
Need for additional antimicrobial therapy with one or more microbiologically active agents before complete resolution of signs and symptoms of infection.
Need for additional active antimicrobial therapy before resolution of signs and symptoms of infection; defined as recovery from infection-related symptoms present at baseline (e.g.; urinary symptoms, abdominal pain, jaundice ..etc), no recurrence of fever (Tmax ≥38.0oC).
Measured: Up to 90 days
Microbiological relapse. 4)
Active infection in any site caused by the same species in the index blood culture.
Measured: 90 days
Infection-related re-admission.
Re-admission to hospital because of any active infection.
Measured: 90 days
Hospital length of stay from date of first positive blood culture.
Hospital length of stay from date of first positive blood culture.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start13 Oct 2019
- Primary completion30 Aug 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Escherichia Coli BacteremiaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Computer generated block randomization into permuted blocks of 4, 6 and 8
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali S Omrani, FRCP FRCPath, Study director, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146922
- Sponsor's protocol ID
- MRC-01-19-254
- Acronym
- SOAB
- Status last verified
- Mar 2022
- First submitted
- 20 Oct 2019
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omrani AS, Abujarir SH, Ben Abid F, Shaar SH, Yilmaz M, Shaukat A, Alsamawi MS, Elgara MS, Alghazzawi MI, Shunnar KM, Zaqout A, Aldeeb YM, Alfouzan W, Almaslamani MA; SOAB Study Group. Switch to oral antibiotics in Gram-negative bacteraemia: a randomized, open-label, clinical trial. Clin Microbiol Infect. 2024 Apr;30(4):492-498. doi: 10.1016/j.cmi.2023.10.014. Epub 2023 Oct 18.
PubMed 37858867
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Oral Antibiotics in Gram-negative Bacteremia (SOAB); a Randomized, Open-label, Clinical Trial.
- ClinicalTrials.gov ID
- NCT04146922
- Acronym / sponsor ID
- SOAB / MRC-01-19-254
- Conditions
- Escherichia Coli Bacteremia, Klebsiella Bacteraemia, Enterobacter Bacteraemia, Serratia Bacteraemia, Citrobacter Bacteraemia, Proteus Bacteraemia
- Keywords
- Enterobacteriaceae, bacteremia, step down oral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 31 Oct 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.
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1,000/ml and hematopoietic or solid organ transplantation within the preceding 90 days. Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary outcome is treatment failure at 90-days with 10% margin for non-inferiority in the 95% confidence interval around the difference in outcome between the two study groups.
Detailed description
Oral antimicrobial therapy mitigates vascular line associated complications such as infection, thrombosis and pain, facilitating early mobilization and discharge and reducing healthcare costs. Efficacy and safety of step-down to oral antimicrobial therapy in patients with Enterobacteriaceae bacteremia has never been confirmed in a randomized clinical trial. The aim of this clinical trial is to evaluate the safety and efficacy of oral step down strategy in patients with Gram-negative blood stream infections.
Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1.0x109/L and hematopoietic or solid organ transplantation within the preceding 90 days.
The primary endpoint is treatment failure at 90-days, defined as a composite of the death from any cause, need for additional antimicrobial therapy with one or more microbiologically active agents before complete resolution of signs and symptoms of infection, microbiological relapse (same species from any clinical site) and infection-related re-admission.
Eligible subjects will be randomized using permuted blocks of variable sizes to full intravenous antimicrobial therapy course (IV Group) or intravenous followed by step-down to oral therapy (PO Group). Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary analysis will include all patients who were randomized and received at least one dose of the assigned treatment. The difference in primary outcome rate between the intervention and control groups will be presented alongside a 95% confidence interval (CI), adjusted by source of bacteremia. If the upper limit of the 95% CI for the difference in overall response is below 10%, non-inferiority will be concluded.
A Data and Safety Monitoring Board will oversee the trial. An interim analysis will be performed after the first 50% of the target sample have completed the 90-day study period. The Data and Safety Monitoring Board can make a binding recommendation to terminate the study if the results of the interim analysis indicate very high likelihood for positive effect or futility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Computer generated block randomization into permuted blocks of 4, 6 and 8
| Arm | Type | Receives |
|---|---|---|
| IV Group | Active comparator | Other: IV antimicrobial therapyEligible patients randomized to complete their antimicrobial therapy course through intravenous (IV) administration. |
| Oral Group | Experimental | Other: Step down to oral antimicrobial therapyEligible patients randomized to step down to oral antimicrobial therapy for the remainder of their treatment course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Mono-microbial blood stream infection.
- Isolation of E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species from ≥1 blood culture(s).
- Adequate source control within ≤5 days of staring in-vitro active intravenous antimicrobial therapy.
- Afebrile (Tmax <38 degrees Celsius) for ≥48 hours.
Key exclusion criteria (7 listed)
- Allergy to all in-vitro active antibiotics which are available in oral formulations.
- Pregnancy.
- Infective endocarditis.
- Central nervous system infection.
- Terminal illness with expected survival <14 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 |
|---|---|---|
| Step down to oral antimicrobial therapyStep down from intravenous to oral antimicrobial therapy to complete the intended course of treatment. | Other | Oral Group |
| IV antimicrobial therapyNo step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment. | Other | IV Group |
Primary outcome
Treatment failure.
Time frame: 90 days
Defined as death, need for additional active antibiotic therapy before resolution of all signs and symptoms of infection, microbiological relapse or infection-related re-admission within 90 days of commencement of active intravenous antimicrobial therapy.
5 secondary outcomes
Death from any cause.
Time frame: 90 days
Need for additional antimicrobial therapy with one or more microbiologically active agents before complete resolution of signs and symptoms of infection.
Time frame: Up to 90 days
Microbiological relapse. 4)
Time frame: 90 days
Infection-related re-admission.
Time frame: 90 days
Hospital length of stay from date of first positive blood culture.
Time frame: Up to 90 days
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 14 Aug 2023.
- Derived from this study: PubMed 37858867Omrani AS, Abujarir SH, Ben Abid F, Shaar SH, Yilmaz M, Shaukat A, Alsamawi MS, Elgara MS, Alghazzawi MI, Shunnar KM, Zaqout A, Aldeeb YM, Alfouzan W, Almaslamani MA; SOAB Study Group. Switch to oral antibiotics in Gram-negative bacteraemia: a randomized, open-label, clinical trial. Clin Microbiol Infect. 2024 Apr;30(4):492-498. doi: 10.1016/j.cmi.2023.10.014. Epub 2023 Oct 18.
- Individual participant dataSharing planned: No
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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.
Ali S Omrani, FRCP FRCPath study director
Hamad Medical Corporation
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step down to oral antimicrobial therapy and IV antimicrobial therapy in people with Escherichia Coli Bacteremia and Klebsiella Bacteraemia, run by Hamad Medical Corporation at 7 sites in 4 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 9 inclusion and 7 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye), Bahrain, Kuwait, Qatar. 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?
Treatment failure. (time frame: 90 days). 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 NCT04146922, which also lists 1 linked publication.
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 14 Aug 2023.