Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

1 Jan 2025 → ongoing

Decision date (initial)

2025-01-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519969-21-00

EudraCT number

2020-001024-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT)

Secondary objectives 3

1. To evaluate quality of life and patient satisfaction
2. To evaluate costs of both interventions through a pharmaco-economic sub-study
3. To evaluate complications related to parenteral and oral administration of antibiotics, such as antibiotic or catheter-related adverse events e.g., phlebitis and line-related bloodstream infections, and superinfections e.g., Clostridium difficile diarrhea.

Conditions and MedDRA coding

Infective endocarditis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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.
2. Male or female 18 years old or older.
3. ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
4. T<38.0° C for more than two days
5. C-reactive protein dropped below 25% of the peak value or below an absolute value of 20 mg/L, and the white blood cell count dropped to less than 15 × 10(9)/L during antibiotic treatment
6. No sign of abscess formation revealed by echocardiography
7. Transthoracic/transesophageal echocardiography performed preferably within 48 h of randomization. Ecoscopy or portable echocardiogram are also admitted, as long as they are registered on the clinical history.

Exclusion criteria 10

1. Body mass index >40
2. Concomitant infection requiring intravenous antibiotic therapy
3. Inability to give informed consent to participation
4. Suspicion of reduced absorption of oral treatment due to abdominal disorder
5. Microorganisms other than those defined in inclusion criteria
6. Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
7. No family or appropriate home support
8. Reduced compliance
9. Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
10. Women in lactancy period

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis

Secondary endpoints 4

1. To evaluate quality of life and patient satisfaction
2. To evaluate costs of both interventions through a pharmacoeconomic analysis.
3. To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others).
4. Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Dr. Guillermo Cuervo

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Dr. Guillermo Cuervo

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications