Endocarditis InfectivePhase 4OraPAT-IEGAMESNCT05398679
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
A Phase 4 study testing Cefaclor, Ciprofloxacin Tablets and Ciprofloxacin Injection in people with Endocarditis Infective, run by Fundacion Clinic per a la Recerca Biomédica at 20 sites in Spain.
Trial summary
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis Infective
- What is being tested?
- Cefaclor, Ciprofloxacin Tablets and Ciprofloxacin Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 20 sitesSpain
- Study dates
- 17 Aug 2022to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Spain20 sites, 20 recruiting
- Recruiting
Hospital General de Alicante
Alicante, Alicante, 03010
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Bizcaia, 48903
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital del Mar
Barcelona, Barcelona, 08003
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Anna Cruceta, MD, +34 932275400 ext. 4380, acruceta@clinic.cat
Laura Burunat, +34 932275400 ext. 4198, burunat@clinic.cat
- Recruiting
Hospital Sant Pau
Barcelona, Barcelona, 08041
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Bellvitge
Barcelona, Barcelona, 08907
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
Laura Burunat Ruesgas, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Virgen de Arrixaca
El Palmar, Murcia, 30120
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital San Pedro
Logroño, La Rioja, 26006
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Virgen de la Macarena
Seville, Andalusia, 41009
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Virgen del Rocío
Seville, Andalusia, 41013
Laura Burunat, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Recruiting
Hospital Mútua de Terrassa
Terrassa, Barcelona, 08221
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
- Not yet recruiting
Hospital Universitari i Politècnic La Fe
Valencia, València, 46009
Laura Burunat, Chemistry, 932275400 ext. 4198, burunat@recerca.clinic.cat
About this study
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Read the 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
- Conditions
- Endocarditis Infective
- Being tested
- Cefaclor, Ciprofloxacin Tablets, Ciprofloxacin Injection, Clindamycin Oral Capsule, Clindamycin Injection
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefaclorDrug
cefaclor intravenous 2 gr/day
Ciprofloxacin TabletsDrug
500-750 mg/12 hrs (maximum 3g x day)
Ciprofloxacin InjectionDrug
1200 mg/day maximum dose IV
Clindamycin Oral CapsuleDrug
600 mg/8 hours (maximum 1.800 mg x day)
Clindamycin InjectionDrug
600 mg/8 hours (maximum 1.800 mg x day) IV
Dicloxacillin Oral CapsuleDrug
1g/8 hours (maximum 4 gr day)
DicloxacillinDrug
1g/8 hours (maximum 4 g x day) IV
Fusidic Acid Only Product in Oral Dose FormDrug
0,750g/12 hours (maximum 1,5 g x day)
Fusidic Acid Only Product in Parenteral Dose FormDrug
0,75 g/12 hours (maximum 1,5 g x day)
Levofloxacin Oral TabletDrug
0.5g/12-24hours (maximum 1 g x day)
Levofloxacin InjectionDrug
0.5g/12-24hours (maximum 1 g x day)
Linezolid Oral TabletDrug
0,6 g/12 hours (maximum 1200 mg x day)
Linezolid Injectable ProductDrug
0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin tabletDrug
0,4 g/day (maximum 400 mg x day)
Moxifloxacin Injectable ProductDrug
0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Oral Dose FormDrug
0,3-0,5 g/12 hours (maximum 1200 mg x day)
Rifampicin Only Product in Parenteral Dose FormDrug
0,3-0,6 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]Drug
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Sulfamethoxazole / Trimethoprim Injectable ProductDrug
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Oral TabletDrug
200 mg tedizolid (maximum x day)
Tedizolid InjectionDrug
200 mg (maximum x day)
Amoxicillin CapsulesDrug
1 gr/6 hours (4 g x day)
AmoxicillinDrug
1 gr/6 hours (4 g x day) Intravenous
Cefaclor CapsulesDrug
2 gr/day
| Study group | Role | What they receive |
|---|---|---|
| OPAT | Active comparator | 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. Receives: Drug: Cefaclor; Drug: Ciprofloxacin Injection; Drug: Clindamycin Injection; Drug: Dicloxacillin; Drug: Fusidic Acid Only Product in Parenteral Dose Form; Drug: Levofloxacin Injection; Drug: Linezolid Injectable Product; Drug: Moxifloxacin Injectable Product; Drug: Rifampicin Only Product in Parenteral Dose Form; Drug: Sulfamethoxazole / Trimethoprim Injectable Product; Drug: Tedizolid Injection; Drug: Amoxicillin |
| Oral Therapy | Experimental | 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. Receives: Drug: Ciprofloxacin Tablets; Drug: Clindamycin Oral Capsule; Drug: Dicloxacillin Oral Capsule; Drug: Fusidic Acid Only Product in Oral Dose Form; Drug: Levofloxacin Oral Tablet; Drug: Linezolid Oral Tablet; Drug: Moxifloxacin tablet; Drug: Rifampicin Only Product in Oral Dose Form; Drug: Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]; Drug: Tedizolid Oral Tablet; Drug: Amoxicillin Capsules; Drug: Cefaclor Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
Measured: At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
Measured: At any time during the study duration (up to 24 months)
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
Measured: within 6 months from diagnosis of Infective Endocarditis
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
Measured: At any time during the study duration (up to 24 months)
Secondary outcomes (3)
Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
Measured: At any time during the study duration (up to 24 months)
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
Measured: At any time during the study duration (up to 24 months)
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
Measured: At any time during the study duration (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start17 Aug 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
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 InfectiveStudies 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
- Model description
- National multi-center study, open, controlled, and randomized
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398679
- Sponsor's protocol ID
- OraPAT-IE GAMES
- Acronym
- OraPAT-IEGAMES
- Status last verified
- Jul 2026
- First submitted
- 4 May 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40024946
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05398679
- Acronym / sponsor ID
- OraPAT-IEGAMES / OraPAT-IE GAMES
- Conditions
- Endocarditis Infective
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Jun 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National multi-center study, open, controlled, and randomized
| Arm | Type | Receives |
|---|---|---|
| OPAT | Active comparator | Drug: Cefaclor, Drug: Ciprofloxacin Injection, Drug: Clindamycin Injection, Drug: Dicloxacillin, Drug: Fusidic Acid Only Product in Parenteral Dose Form, Drug: Levofloxacin Injection, Drug: Linezolid Injectable Product, Drug: Moxifloxacin Injectable Product, Drug: Rifampicin Only Product in Parenteral Dose Form, Drug: Sulfamethoxazole / Trimethoprim Injectable Product, Drug: Tedizolid Injection, Drug: AmoxicillinPatients 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. |
| Oral Therapy | Experimental | Drug: Ciprofloxacin Tablets, Drug: Clindamycin Oral Capsule, Drug: Dicloxacillin Oral Capsule, Drug: Fusidic Acid Only Product in Oral Dose Form, Drug: Levofloxacin Oral Tablet, Drug: Linezolid Oral Tablet, Drug: Moxifloxacin tablet, Drug: Rifampicin Only Product in Oral Dose Form, Drug: Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim], Drug: Tedizolid Oral Tablet, Drug: Amoxicillin Capsules, Drug: Cefaclor CapsulesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Cefaclorcefaclor intravenous 2 gr/day | Drug | OPAT |
| Ciprofloxacin Tablets500-750 mg/12 hrs (maximum 3g x day) | Drug | Oral Therapy |
| Ciprofloxacin Injection1200 mg/day maximum dose IV | Drug | OPAT |
| Clindamycin Oral Capsule600 mg/8 hours (maximum 1.800 mg x day) | Drug | Oral Therapy |
| Clindamycin Injection600 mg/8 hours (maximum 1.800 mg x day) IV | Drug | OPAT |
| Dicloxacillin Oral Capsule1g/8 hours (maximum 4 gr day) | Drug | Oral Therapy |
| Dicloxacillin1g/8 hours (maximum 4 g x day) IV | Drug | OPAT |
| Fusidic Acid Only Product in Oral Dose Form0,750g/12 hours (maximum 1,5 g x day) | Drug | Oral Therapy |
| Fusidic Acid Only Product in Parenteral Dose Form0,75 g/12 hours (maximum 1,5 g x day) | Drug | OPAT |
| Levofloxacin Oral Tablet0.5g/12-24hours (maximum 1 g x day) | Drug | Oral Therapy |
| Levofloxacin Injection0.5g/12-24hours (maximum 1 g x day) | Drug | OPAT |
| Linezolid Oral Tablet0,6 g/12 hours (maximum 1200 mg x day) | Drug | Oral Therapy |
| Linezolid Injectable Product0,6 g/12 hours (maximum 1200 mg x day) | Drug | OPAT |
| Moxifloxacin tablet0,4 g/day (maximum 400 mg x day) | Drug | Oral Therapy |
| Moxifloxacin Injectable Product0,4 g/day (maximum 400 mg x day) | Drug | OPAT |
| Rifampicin Only Product in Oral Dose Form0,3-0,5 g/12 hours (maximum 1200 mg x day) | Drug | Oral Therapy |
| Rifampicin Only Product in Parenteral Dose Form0,3-0,6 g/12 hours (maximum 1200 mg x day) | Drug | OPAT |
| Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day) | Drug | Oral Therapy |
| Sulfamethoxazole / Trimethoprim Injectable Productsulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day) | Drug | OPAT |
| Tedizolid Oral Tablet200 mg tedizolid (maximum x day) | Drug | Oral Therapy |
| Tedizolid Injection200 mg (maximum x day) | Drug | OPAT |
| Amoxicillin Capsules1 gr/6 hours (4 g x day) | Drug | Oral Therapy |
| Amoxicillin1 gr/6 hours (4 g x day) Intravenous | Drug | OPAT |
| Cefaclor Capsules2 gr/day | Drug | Oral Therapy |
Primary outcome
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)
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)
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
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)
3 secondary outcomes
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)
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
Time frame: At any time during the study duration (up to 24 months)
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
Time frame: At any time during the study duration (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 40024946Cuervo 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.
- Individual participant dataSharing planned: Undecided
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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.
20 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 Cefaclor, Ciprofloxacin Tablets and Ciprofloxacin Injection in people with Endocarditis Infective, run by Fundacion Clinic per a la Recerca Biomédica at 20 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Cruceta (+34 932275400 ext. 4380, acruceta@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. 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 NCT05398679, 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 7 Jul 2026.