Back to resultsOral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (OraPAT-IEGAMES)
Primary Purpose
Endocarditis Infective
Status
Not yet recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Cefaclor
Ciprofloxacin Tablets
Ciprofloxacin Injection
Clindamycin Oral Capsule
Clindamycin Injection
Dicloxacillin Oral Capsule
Dicloxacillin
Fusidic Acid Only Product in Oral Dose Form
Fusidic Acid Only Product in Parenteral Dose Form
Levofloxacin Oral Tablet
Levofloxacin Injection
Linezolid Oral Tablet
Linezolid Injectable Product
Moxifloxacin tablet
Moxifloxacin Injectable Product
Rifampicin Only Product in Oral Dose Form
Rifampicin Only Product in Parenteral Dose Form
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
Sulfamethoxazole / Trimethoprim Injectable Product
Tedizolid Oral Tablet
Tedizolid Injection
Amoxicillin Capsules
Amoxicillin
Cefaclor Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Endocarditis Infective
Eligibility Criteria
Inclusion Criteria:
- Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
- Male or female 18 years old or older.
- 10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.
- Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to <25% of peak value or <20 mg/l, and white blood cell count <15x10^9/l during antibiotic treatment
- Transthoracic / transesophageal echocardiography performed within 48 hours of randomization
Exclusion Criteria:
- Body mass index >40
- Concomitant infection requiring intravenous antibiotic therapy
- Inability to give informed consent to participation
- Suspicion of reduced absorption of oral treatment due to abdominal disorder
- Microorganisms with no oral combinations for treatment (two active antibiotics of different families)
- Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
- No family or appropriate home support
- Reduced compliance
- Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period
- Women in lactancy period
Sites / Locations
- Hospital Clinic i Provincial de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
OPAT
Oral Therapy
Arm Description
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve parenteral antibiotics until the end of treatment.
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve oral antibiotics until the end of treatment.
Outcomes
Primary Outcome Measures
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
Secondary Outcome Measures
Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
Costs of both interventions, measured through a pharmaco-economic sub-study including direct and indirect costs, following the methodology described by Lacroix A et al Med Mal Infect. 2014
through a pharmacoeconomic analysis
The complications related to parenteral and oral administration of antibiotics will be measured through the number of antibiotic adverse reactions, catheter-related adverse events, and number of superinfections
such as antibiotic or catheter-related adverse events e.g.,phlebitis and line-related bloodstream infections, and superinfections
Full Information
NCT ID
NCT05398679
First Posted
May 4, 2022
Last Updated
May 26, 2022
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT05398679
Brief Title
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Acronym
OraPAT-IEGAMES
Official Title
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Detailed Description
The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy
This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis Infective
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
National multi-center study, open, controlled, and randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OPAT
Arm Type
Active Comparator
Arm Description
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve parenteral antibiotics until the end of treatment.
Arm Title
Oral Therapy
Arm Type
Experimental
Arm Description
Patients with infective endocarditis diagnostic, who have completed at least 10 days of intravenous therapy, and/ or seven days in the case of cardiac valvular surgery, and shown good clinical evolution and no clinical or echocardiographic signs of potential bad prognosis will be randomized. If assigned to this arm the patient will recieve oral antibiotics until the end of treatment.
Intervention Type
Drug
Intervention Name(s)
Cefaclor
Intervention Description
cefaclor intravenous 2 gr/day
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin Tablets
Intervention Description
500-750 mg/12 hrs (maximum 3g x day)
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin Injection
Intervention Description
1200 mg/day maximum dose IV
Intervention Type
Drug
Intervention Name(s)
Clindamycin Oral Capsule
Intervention Description
600 mg/8 hours (maximum 1.800 mg x day)
Intervention Type
Drug
Intervention Name(s)
Clindamycin Injection
Intervention Description
600 mg/8 hours (maximum 1.800 mg x day) IV
Intervention Type
Drug
Intervention Name(s)
Dicloxacillin Oral Capsule
Intervention Description
1g/8 hours (maximum 4 gr day)
Intervention Type
Drug
Intervention Name(s)
Dicloxacillin
Intervention Description
1g/8 hours (maximum 4 g x day) IV
Intervention Type
Drug
Intervention Name(s)
Fusidic Acid Only Product in Oral Dose Form
Intervention Description
0,750g/12 hours (maximum 1,5 g x day)
Intervention Type
Drug
Intervention Name(s)
Fusidic Acid Only Product in Parenteral Dose Form
Intervention Description
0,75 g/12 hours (maximum 1,5 g x day)
Intervention Type
Drug
Intervention Name(s)
Levofloxacin Oral Tablet
Intervention Description
0.5g/12-24hours (maximum 1 g x day)
Intervention Type
Drug
Intervention Name(s)
Levofloxacin Injection
Intervention Description
0.5g/12-24hours (maximum 1 g x day)
Intervention Type
Drug
Intervention Name(s)
Linezolid Oral Tablet
Intervention Description
0,6 g/12 hours (maximum 1200 mg x day)
Intervention Type
Drug
Intervention Name(s)
Linezolid Injectable Product
Intervention Description
0,6 g/12 hours (maximum 1200 mg x day)
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin tablet
Intervention Description
0,4 g/day (maximum 400 mg x day)
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Injectable Product
Intervention Description
0,4 g/day (maximum 400 mg x day)
Intervention Type
Drug
Intervention Name(s)
Rifampicin Only Product in Oral Dose Form
Intervention Description
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Intervention Type
Drug
Intervention Name(s)
Rifampicin Only Product in Parenteral Dose Form
Intervention Description
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
Intervention Description
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole / Trimethoprim Injectable Product
Intervention Description
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Intervention Type
Drug
Intervention Name(s)
Tedizolid Oral Tablet
Intervention Description
200 mg tedizolid (maximum x day)
Intervention Type
Drug
Intervention Name(s)
Tedizolid Injection
Intervention Description
200 mg (maximum x day)
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Capsules
Intervention Description
1 gr/6 hours (4 g x day)
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
1 gr/6 hours (4 g x day) Intravenous
Intervention Type
Drug
Intervention Name(s)
Cefaclor Capsules
Intervention Description
2 gr/day
Primary Outcome Measure Information:
Title
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
Time Frame
At any time during the study duration (up to 24 months)
Title
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
Time Frame
At any time during the study duration (up to 24 months)
Title
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
Time Frame
within 6 months from diagnosis of Infective Endocarditis
Title
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
Time Frame
At any time during the study duration (up to 24 months)
Secondary Outcome Measure Information:
Title
Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
Time Frame
At any time during the study duration (up to 24 months)
Title
Costs of both interventions, measured through a pharmaco-economic sub-study including direct and indirect costs, following the methodology described by Lacroix A et al Med Mal Infect. 2014
Description
through a pharmacoeconomic analysis
Time Frame
At any time during the study duration (up to 24 months)
Title
The complications related to parenteral and oral administration of antibiotics will be measured through the number of antibiotic adverse reactions, catheter-related adverse events, and number of superinfections
Description
such as antibiotic or catheter-related adverse events e.g.,phlebitis and line-related bloodstream infections, and superinfections
Time Frame
At any time during the study duration (up to 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
Male or female 18 years old or older.
10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.
Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to <25% of peak value or <20 mg/l, and white blood cell count <15x10^9/l during antibiotic treatment
Transthoracic / transesophageal echocardiography performed within 48 hours of randomization
Exclusion Criteria:
Body mass index >40
Concomitant infection requiring intravenous antibiotic therapy
Inability to give informed consent to participation
Suspicion of reduced absorption of oral treatment due to abdominal disorder
Microorganisms with no oral combinations for treatment (two active antibiotics of different families)
Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
No family or appropriate home support
Reduced compliance
Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period
Women in lactancy period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Cruceta
Phone
+34 932275400
Ext
4380
Email
acruceta@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Burunat
Phone
+34 932275400
Ext
4198
Email
burunat@clinic.cat
Facility Information:
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Cruceta, MD
Phone
+34 932275400
Ext
4380
Email
acruceta@clinic.cat
First Name & Middle Initial & Last Name & Degree
Laura Burunat
Phone
+34 932275400
Ext
4198
Email
burunat@clinic.cat
First Name & Middle Initial & Last Name & Degree
Juan Ambrosioni, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
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