Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
NCT ID: NCT05398679
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
360 participants
INTERVENTIONAL
2022-08-17
2027-12-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OPAT
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.
Cefaclor
cefaclor intravenous 2 gr/day
Ciprofloxacin Injection
1200 mg/day maximum dose IV
Clindamycin Injection
600 mg/8 hours (maximum 1.800 mg x day) IV
Dicloxacillin
1g/8 hours (maximum 4 g x day) IV
Fusidic Acid Only Product in Parenteral Dose Form
0,75 g/12 hours (maximum 1,5 g x day)
Levofloxacin Injection
0.5g/12-24hours (maximum 1 g x day)
Linezolid Injectable Product
0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin Injectable Product
0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Parenteral Dose Form
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Injectable Product
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Injection
200 mg (maximum x day)
Amoxicillin
1 gr/6 hours (4 g x day) Intravenous
Oral Therapy
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.
Ciprofloxacin Tablets
500-750 mg/12 hrs (maximum 3g x day)
Clindamycin Oral Capsule
600 mg/8 hours (maximum 1.800 mg x day)
Dicloxacillin Oral Capsule
1g/8 hours (maximum 4 gr day)
Fusidic Acid Only Product in Oral Dose Form
0,750g/12 hours (maximum 1,5 g x day)
Levofloxacin Oral Tablet
0.5g/12-24hours (maximum 1 g x day)
Linezolid Oral Tablet
0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin tablet
0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Oral Dose Form
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Oral Tablet
200 mg tedizolid (maximum x day)
Amoxicillin Capsules
1 gr/6 hours (4 g x day)
Cefaclor Capsules
2 gr/day
Interventions
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Cefaclor
cefaclor intravenous 2 gr/day
Ciprofloxacin Tablets
500-750 mg/12 hrs (maximum 3g x day)
Ciprofloxacin Injection
1200 mg/day maximum dose IV
Clindamycin Oral Capsule
600 mg/8 hours (maximum 1.800 mg x day)
Clindamycin Injection
600 mg/8 hours (maximum 1.800 mg x day) IV
Dicloxacillin Oral Capsule
1g/8 hours (maximum 4 gr day)
Dicloxacillin
1g/8 hours (maximum 4 g x day) IV
Fusidic Acid Only Product in Oral Dose Form
0,750g/12 hours (maximum 1,5 g x day)
Fusidic Acid Only Product in Parenteral Dose Form
0,75 g/12 hours (maximum 1,5 g x day)
Levofloxacin Oral Tablet
0.5g/12-24hours (maximum 1 g x day)
Levofloxacin Injection
0.5g/12-24hours (maximum 1 g x day)
Linezolid Oral Tablet
0,6 g/12 hours (maximum 1200 mg x day)
Linezolid Injectable Product
0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin tablet
0,4 g/day (maximum 400 mg x day)
Moxifloxacin Injectable Product
0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Oral Dose Form
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Rifampicin Only Product in Parenteral Dose Form
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Sulfamethoxazole / Trimethoprim Injectable Product
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Oral Tablet
200 mg tedizolid (maximum x day)
Tedizolid Injection
200 mg (maximum x day)
Amoxicillin Capsules
1 gr/6 hours (4 g x day)
Amoxicillin
1 gr/6 hours (4 g x day) Intravenous
Cefaclor Capsules
2 gr/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Anna Cruceta
Project Manager Clinical Trial Unit
Locations
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Hospital Virgen de la Macarena
Seville, Andalusia, Spain
Hospital Virgen del Rocío
Seville, Andalusia, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizcaia, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Virgen de Arrixaca
El Palmar, Murcia, Spain
Hospital universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital General de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital Bellvitge
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Cuervo G, Hernandez-Meneses M, de Alarcon A, Luque-Marquez R, Alonso-Socas MM, Lopez-Lirola A, Gonzalez-Ramallo V, Goikoetxea-Agirre AJ, Nicolas D, Goenaga MA, Merino E, Escrihuela-Vidal F, Martin-Davila P, Loeches B, Boix-Palop L, Gasch O, Camprecios M, Hernandez-Torres A, Garcia-Alvarez L, Pajaron M, Ribas MA, Blanes-Hernandez R, Lopez-Montesinos I, Lopez-Cortes LE, Vidal B, Fernandez-Pittol M, Navarro D, Moreno A, Sala C, Ambrosioni J, Miro JM; OraPAT-IE GAMES Investigators. Oral vs. Outpatient Parenteral Antimicrobial Treatment for Infective Endocarditis: Study Protocol for the Spanish OraPAT-IE GAMES Trial. Infect Dis Ther. 2025 Mar;14(3):643-655. doi: 10.1007/s40121-025-01110-9. Epub 2025 Mar 1.
Other Identifiers
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OraPAT-IE GAMES
Identifier Type: -
Identifier Source: org_study_id
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