Infective EndocarditisPhase 4NCT00871104
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
A Phase 4 study testing Fosfomycin and imipenem and Vancomycin in people with Infective Endocarditis, run by Juan A. Arnaiz at 10 sites in Spain.
Trial summary
The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Fosfomycin and imipenem and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesSpain
- Study dates
- Jul 2009to 15 Apr 2015
- 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
- Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).
- Patients over 18 years.
Who cannot join
- Patients who did not sign informed consent.
- Patients with active consumption intravenous drug.
- Patients with emergent surgery criteria (<72 hours).
- Patients or cardiogenic shock.
- Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.
- Patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / mL on the third day.
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- Patients with MRSA strains resistant to fosfomycin (MIC> 64 mg / L) (<10%) or vancomycin (MIC> 2 mg / L) or with an MIC to vancomycin of 2 mg / L.
- Patients with any formal contraindication to be treated with study drugs
- Patients treated with any investigational drug within 30 days prior to entering the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Fundación Hospital Alcorcón
Alcorcón - Madrid, Madrid, 28922
Hospital Sant Pau of Barcelona
Barcelona, Catalonia, 08025
Hospital Clínic of Barcelona
Barcelona, Catalonia, 08036
Hospital Bellvitge of Barcelona
Barcelona, Catalonia, 08907
Hospital de Cruces
Bilbao, Vizcaya, 48903
Hospital Gregorio Marañón
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28034
Hospital La Paz
Madrid, 28046
Hospital Virgen Macarena
Seville, 410071
Hospital Virgen del Rocío
Seville, 41013
About this study
Official title: Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.
- Conditions
- Infective Endocarditis
- Being tested
- Fosfomycin and imipenem, Vancomycin
- Keywords
- Infective endocarditis
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycin and imipenemDrug
IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks
VancomycinDrug
IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IV fosfomycin and imipenem adjusted to renal function Receives: Drug: Fosfomycin and imipenem |
| 2 | Active comparator | IV Vancomycin twice a day with valley leves higher than 15 mcg/kg Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with negative blood cultures.
Measured: 7 days
Secondary outcomes (1)
Toxicity due to treatment
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2014
- Study completion15 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Asunción Moreno Camacho, MD, Principal investigator, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871104
- Sponsor's protocol ID
- FOSIMI
- Other IDs
- EudraCT number: 2008-008683-28
- Status last verified
- Mar 2018
- First submitted
- 27 Mar 2009
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pericas JM, Hernandez-Meneses M, Munoz P, Martinez-Selles M, Alvarez-Uria A, de Alarcon A, Gutierrez-Carretero E, Goenaga MA, Zarauza MJ, Falces C, Rodriguez-Esteban MA, Hidalgo-Tenorio C, Hernandez-Cabrera M, Miro JM; Spanish Collaboration on Endocarditis-Grupo de Apoyo al Manejo de la Endocarditis Infecciosa en Espana (GAMES). Characteristics and Outcome of Acute Heart Failure in Infective Endocarditis: Focus on Cardiogenic Shock. Clin Infect Dis. 2021 Sep 7;73(5):765-774. doi: 10.1093/cid/ciab098.
PubMed 33560404Pericas JM, Ambrosioni J, Munoz P, de Alarcon A, Kestler M, Mari-Hualde A, Moreno A, Goenaga MA, Farinas MC, Rodriguez-Alvarez R, Ojeda-Burgos G, Galvez-Acebal J, Hidalgo-Tenorio C, Noureddine M, Miro JM; GAMES Investigators. Prevalence of Colorectal Neoplasms Among Patients With Enterococcus faecalis Endocarditis in the GAMES Cohort (2008-2017). Mayo Clin Proc. 2021 Jan;96(1):132-146. doi: 10.1016/j.mayocp.2020.06.056.
PubMed 33413809Pericas JM, Llopis J, Munoz P, Galvez-Acebal J, Kestler M, Valerio M, Hernandez-Meneses M, Goenaga MA, Cobo-Belaustegui M, Montejo M, Ojeda-Burgos G, Sousa-Regueiro MD, de Alarcon A, Ramos-Martinez A, Miro JM; GAMES Investigators. A Contemporary Picture of Enterococcal Endocarditis. J Am Coll Cardiol. 2020 Feb 11;75(5):482-494. doi: 10.1016/j.jacc.2019.11.047.
PubMed 32029130del Rio A, Gasch O, Moreno A, Pena C, Cuquet J, Soy D, Mestres CA, Suarez C, Pare JC, Tubau F, Garcia de la Maria C, Marco F, Carratala J, Gatell JM, Gudiol F, Miro JM; FOSIMI Investigators. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial. Clin Infect Dis. 2014 Oct 15;59(8):1105-12. doi: 10.1093/cid/ciu580. Epub 2014 Jul 21.
PubMed 25048851
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
- ClinicalTrials.gov ID
- NCT00871104
- Acronym / sponsor ID
- FOSIMI
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- 15 Apr 2015 (actual)
- First posted
- 30 Mar 2009 (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.
The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fosfomycin and imipenemIV fosfomycin and imipenem adjusted to renal function |
| 2 | Active comparator | Drug: VancomycinIV Vancomycin twice a day with valley leves higher than 15 mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).
- Patients over 18 years.
Key exclusion criteria (9 listed)
- Patients who did not sign informed consent.
- Patients with active consumption intravenous drug.
- Patients with emergent surgery criteria (<72 hours).
- Patients or cardiogenic shock.
- Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.
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 |
|---|---|---|
| Fosfomycin and imipenemIV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks | Drug | 1 |
| VancomycinIV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg | Drug | 2 |
Primary outcome
Proportion of patients with negative blood cultures.
Time frame: 7 days
1 secondary outcome
Toxicity due to treatment
Time frame: 20 weeks
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 8 Mar 2018.
- Derived from this study: PubMed 33560404Pericas JM, Hernandez-Meneses M, Munoz P, Martinez-Selles M, Alvarez-Uria A, de Alarcon A, Gutierrez-Carretero E, Goenaga MA, Zarauza MJ, Falces C, Rodriguez-Esteban MA, Hidalgo-Tenorio C, Hernandez-Cabrera M, Miro JM; Spanish Collaboration on Endocarditis-Grupo de Apoyo al Manejo de la Endocarditis Infecciosa en Espana (GAMES). Characteristics and Outcome of Acute Heart Failure in Infective Endocarditis: Focus on Cardiogenic Shock. Clin Infect Dis. 2021 Sep 7;73(5):765-774. doi: 10.1093/cid/ciab098.
- Derived from this study: PubMed 33413809Pericas JM, Ambrosioni J, Munoz P, de Alarcon A, Kestler M, Mari-Hualde A, Moreno A, Goenaga MA, Farinas MC, Rodriguez-Alvarez R, Ojeda-Burgos G, Galvez-Acebal J, Hidalgo-Tenorio C, Noureddine M, Miro JM; GAMES Investigators. Prevalence of Colorectal Neoplasms Among Patients With Enterococcus faecalis Endocarditis in the GAMES Cohort (2008-2017). Mayo Clin Proc. 2021 Jan;96(1):132-146. doi: 10.1016/j.mayocp.2020.06.056.
- Derived from this study: PubMed 32029130Pericas JM, Llopis J, Munoz P, Galvez-Acebal J, Kestler M, Valerio M, Hernandez-Meneses M, Goenaga MA, Cobo-Belaustegui M, Montejo M, Ojeda-Burgos G, Sousa-Regueiro MD, de Alarcon A, Ramos-Martinez A, Miro JM; GAMES Investigators. A Contemporary Picture of Enterococcal Endocarditis. J Am Coll Cardiol. 2020 Feb 11;75(5):482-494. doi: 10.1016/j.jacc.2019.11.047.
- Derived from this study: PubMed 25048851del Rio A, Gasch O, Moreno A, Pena C, Cuquet J, Soy D, Mestres CA, Suarez C, Pare JC, Tubau F, Garcia de la Maria C, Marco F, Carratala J, Gatell JM, Gudiol F, Miro JM; FOSIMI Investigators. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial. Clin Infect Dis. 2014 Oct 15;59(8):1105-12. doi: 10.1093/cid/ciu580. Epub 2014 Jul 21.
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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.
Asunción Moreno Camacho, MD principal investigator
Hospital Clínic of Barcelona
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosfomycin and imipenem and Vancomycin in people with Infective Endocarditis, run by Juan A. Arnaiz at 10 sites 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 2 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: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 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 patients with negative blood cultures. (time frame: 7 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 NCT00871104, which also lists 4 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 8 Mar 2018.