A Phase 4 interventional study of Cefaclor and Ciprofloxacin Tablets in Endocarditis Infective, sponsored by Fundacion Clinic per a la Recerca Biomédica. Recruiting at 20 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Fundacion Clinic per a la Recerca Biomédica · Phase 4, Interventional, and Treatment
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
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
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 360 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Fundacion Clinic per a la Recerca Biomédica is the lead sponsor of 64 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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
cefaclor intravenous 2 gr/day
500-750 mg/12 hrs (maximum 3g x day)
1200 mg/day maximum dose IV
600 mg/8 hours (maximum 1.800 mg x day)
600 mg/8 hours (maximum 1.800 mg x day) IV
1g/8 hours (maximum 4 gr day)
1g/8 hours (maximum 4 g x day) IV
0,750g/12 hours (maximum 1,5 g x day)
0,75 g/12 hours (maximum 1,5 g x day)
0.5g/12-24hours (maximum 1 g x day)
0.5g/12-24hours (maximum 1 g x day)
0,6 g/12 hours (maximum 1200 mg x day)
0,6 g/12 hours (maximum 1200 mg x day)
0,4 g/day (maximum 400 mg x day)
0,4 g/day (maximum 400 mg x day)
0,3-0,5 g/12 hours (maximum 1200 mg x day)
0,3-0,6 g/12 hours (maximum 1200 mg x day)
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Drug pages: Sulfamethoxazole · Trimethoprim
sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
200 mg tedizolid (maximum x day)
200 mg (maximum x day)
1 gr/6 hours (4 g x day)
1 gr/6 hours (4 g x day) Intravenous
2 gr/day
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)
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
through a pharmacoeconomic analysis
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
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)
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Ciprofloxacin · Clindamycin · Dicloxacillin · Levofloxacin · Linezolid · Moxifloxacin · Tedizolid · Amoxicillin
Fundacion Clinic per a la Recerca Biomédica