Endocarditis, BacterialPhase 4SATIENCT04222257
Short-course Antibiotic Treatment in Gram-positive Cocci Infective Endocarditis
A Phase 4 study testing Antibiotics in people with Endocarditis, Bacterial, run by Carmen Olmos Blanco at 1 site in Spain.
Trial summary
Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Bacterial
- What is being tested?
- Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2021to 1 Apr 2023
- Phase
- Phase 4
- 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
- Definite IE, according to modified ESC 2015 criteria, caused by gram-positive cocci (staphylococci, streptococci and enterococci), including native, prosthetic valve IE and cardiac device-related IE.
- 18 years old or older.
- Patients treated for at least 10 days of appropriate parenteral antibiotic therapy overall (according to guidelines and microbiology sensitivity testing), and at least 7 days of parenteral antibiotic therapy after valve surgery when indicated.
- Absence of fever, microbiological or analytical findings suggesting persistent infection at randomization.
- Absence of locally uncontrolled infection signs (abscess, pseudoaneurysm, fistula, enlarging vegetation) at randomization, confirmed by recent transesophageal echocardiography (performed within 48 h of randomization).
- Women of childbearing potential who will agree to the use of effective contraceptive methods while on antibiotic treatment.
Who cannot join
- Patients who have received appropriate parenteral antibiotic therapy for infective endocarditis for more than 12 days.
- Patients not suitable to be discharged after 10 days of conventional treatment, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
- Patients receiving chemotherapy or immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Need of prolonged antibiotic therapy due to spondylodiscitis or other septic complication.
- Absence of patient's ability or commitment to continue follow-up after being discharged from hospital.
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- Inability to give informed consent to participation.
- Cognitive impairment or lack of language skills needed to complete the questionnaires.
- Patients who meet urgent cardiac surgery ESC criteria but are considered inoperable due to high surgical risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis: Randomized Clinical Trial
Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Subsequently, the vast majority of patients who overcome this acute phase has a favourable evolution, and usually stay in the hospital for a long time only to complete antibiotic therapy.
In stable patients with adequate response to antibiotic treatment, without signs of persistent infection or metastatic foci such as spondylodiscitis, it is likely that a shorter antibiotic regimen would be an efficient and safe alternative, as has already been confirmed in patients with IE on tricuspid valves caused by a microorganism considered virulent such as S. aureus. This attractive alternative would improve patients' quality of life, save costs, and decrease the risk of complications related to the adverse effects of prolonged antibiotic treatment.
Read more
Objectives: to compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion between patients with IE caused by gram-positive cocci receiving a short-course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy (4-6 weeks).
Methodology: multicenter, prospective, randomized, controlled open-label, phase IV clinical trial. Sample: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. Intervention: Control group: standard antibiotic therapy, according to ESC guidelines recommendations, for 4 to 6 weeks. Experimental group: short-course antibiotic therapy for 2 weeks. The prevalence of previously known risk factors for adverse events will be compared between the two groups to confirm that randomization have worked properly. The incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
- Conditions
- Endocarditis, Bacterial
- Being tested
- Antibiotics
- Keywords
- Infective endocarditis, short-course, antibiotic therapy
- Medical subject headings
- Endocarditis, Bacterial, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Patients allocated to this group will receive a short course of antibiotic therapy for 2 weeks.
AntibioticsDrug
Patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Short course | Experimental | Patients allocated to this group will receive a short course of antibiotic therapy for 2 weeks. Receives: Drug: Antibiotics |
| Standard course | Active comparator | Those patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks. Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endopoint
To compare the incidence of the composite endpoint that includes all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion, between patients with IE caused by gram-positive cocci receiving a short course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy for 4-6 weeks.
Measured: 6 months
Secondary outcomes (4)
Perceived quality of life: SF-12
Determination of quality of life (SF-12)
Measured: 4 weeks
Functional performance
Determination of functional performance according to the short performance physical battery test (SPPB)
Measured: 4 weeks
Clinical complications
Clinical complications related to hospital stay (nosocomial infections, intravascular catheter-related infections)
Measured: 6 months
Total hospital length of stay
Total hospital length of stay in the next 6 months after the inclusion in the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start26 Jan 2021
- Primary completion31 Mar 2023
- Study completion1 Apr 2023
Why it stopped: Inability to reach the estimated sample size
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 Endocarditis, BacterialStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmen Olmos Blanco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Olmos Blanco, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222257
- Sponsor's protocol ID
- SATIE
- Acronym
- SATIE
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olmos C, Vilacosta I, Lopez J, Saez C, Anguita M, Garcia-Granja PE, Sarria C, Silva J, Alvarez-Alvarez B, Martinez-Monzonis MA, Castillo JC, Seijas J, Lopez-Picado A, Peral V, Maroto L, San Roman JA. Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE). BMC Infect Dis. 2020 Jun 16;20(1):417. doi: 10.1186/s12879-020-05132-1.
PubMed 32546269
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04222257
- Acronym / sponsor ID
- SATIE / SATIE
- Conditions
- Endocarditis, Bacterial
- Keywords
- Infective endocarditis, short-course, antibiotic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to reach the estimated sample size
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Carmen Olmos BlancoUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 9 Jan 2020 (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.
Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Subsequently, the vast majority of patients who overcome this acute phase has a favourable evolution, and usually stay in the hospital for a long time only to complete antibiotic therapy.
In stable patients with adequate response to antibiotic treatment, without signs of persistent infection or metastatic foci such as spondylodiscitis, it is likely that a shorter antibiotic regimen would be an efficient and safe alternative, as has already been confirmed in patients with IE on tricuspid valves caused by a microorganism considered virulent such as S. aureus. This attractive alternative would improve patients' quality of life, save costs, and decrease the risk of complications related to the adverse effects of prolonged antibiotic treatment.
Objectives: to compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion between patients with IE caused by gram-positive cocci receiving a short-course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy (4-6 weeks).
Methodology: multicenter, prospective, randomized, controlled open-label, phase IV clinical trial. Sample: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. Intervention: Control group: standard antibiotic therapy, according to ESC guidelines recommendations, for 4 to 6 weeks. Experimental group: short-course antibiotic therapy for 2 weeks. The prevalence of previously known risk factors for adverse events will be compared between the two groups to confirm that randomization have worked properly. The incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short course | Experimental | Drug: AntibioticsPatients allocated to this group will receive a short course of antibiotic therapy for 2 weeks. |
| Standard course | Active comparator | Drug: AntibioticsThose patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Definite IE, according to modified ESC 2015 criteria, caused by gram-positive cocci (staphylococci, streptococci and enterococci), including native, prosthetic valve IE and cardiac device-related IE.
- 18 years old or older.
- Patients treated for at least 10 days of appropriate parenteral antibiotic therapy overall (according to guidelines and microbiology sensitivity testing), and at least 7 days of parenteral antibiotic therapy after valve surgery when indicated.
- Absence of fever, microbiological or analytical findings suggesting persistent infection at randomization.
- Absence of locally uncontrolled infection signs (abscess, pseudoaneurysm, fistula, enlarging vegetation) at randomization, confirmed by recent transesophageal echocardiography (performed within 48 h of randomization).
Key exclusion criteria (9 listed)
- Patients who have received appropriate parenteral antibiotic therapy for infective endocarditis for more than 12 days.
- Patients not suitable to be discharged after 10 days of conventional treatment, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
- Patients receiving chemotherapy or immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Need of prolonged antibiotic therapy due to spondylodiscitis or other septic complication.
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 |
|---|---|---|
| AntibioticsPatients allocated to this group will receive a short course of antibiotic therapy for 2 weeks. | Drug | Short course |
| AntibioticsPatients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks. | Drug | Standard course |
Primary outcome
Composite endopoint
Time frame: 6 months
To compare the incidence of the composite endpoint that includes all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion, between patients with IE caused by gram-positive cocci receiving a short course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy for 4-6 weeks.
4 secondary outcomes
Perceived quality of life: SF-12
Time frame: 4 weeks
Functional performance
Time frame: 4 weeks
Clinical complications
Time frame: 6 months
Total hospital length of stay
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Inability to reach the estimated sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 32546269Olmos C, Vilacosta I, Lopez J, Saez C, Anguita M, Garcia-Granja PE, Sarria C, Silva J, Alvarez-Alvarez B, Martinez-Monzonis MA, Castillo JC, Seijas J, Lopez-Picado A, Peral V, Maroto L, San Roman JA. Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE). BMC Infect Dis. 2020 Jun 16;20(1):417. doi: 10.1186/s12879-020-05132-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotics in people with Endocarditis, Bacterial, run by Carmen Olmos Blanco at 1 site in Spain.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to reach the estimated sample size). 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?
Composite endopoint (time frame: 6 months). 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 NCT04222257, 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 28 Sep 2023.