Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Endocarditis Infective Clinical Trial

— OraPAT-IEGAMES  

Official title:

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05398679
• Other study ID #: OraPAT-IE GAMES
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2022
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Anna Cruceta
• Phone: +34 932275400
• Email: acruceta[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis Infective
• Endocarditis, Bacterial

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations		At any time during the study duration (up to 24 months)
Primary	Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality		At any time during the study duration (up to 24 months)
Primary	Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis		within 6 months from diagnosis of Infective Endocarditis
Primary	Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery		At any time during the study duration (up to 24 months)
Secondary	Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction		At any time during the study duration (up to 24 months)
Secondary	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	At any time during the study duration (up to 24 months)
Secondary	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	At any time during the study duration (up to 24 months)