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New treatment option for Endocarditis Infective
Official title Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
ClinicalTrials.gov ID: NCT05398679
What this study is testing
What is Cefaclor?
Cefaclor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endocarditis infective.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant...
- 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...
- Transthoracic / transesophageal echocardiography performed within 48 hours of randomization
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Alicante, Spain
- Seville, Andalusia, Spain
- Palma de Mallorca, Balearic Islands, Spain
- Barcelona, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Terrassa, Barcelona, Spain
- Barakaldo, Bizcaia, Spain
- Santander, Cantabria, Spain
- Donostia / San Sebastian, Guipuzcoa, Spain
- Logroño, La Rioja, Spain
- Madrid, Madrid, Spain
- El Palmar, Murcia, Spain
- San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
- Valencia, València, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Alicante, Spain; Seville, Andalusia, Spain; Palma de Mallorca, Balearic Islands, Spain; Barcelona, Barcelona, Spain; Sabadell, Barcelona, Spain; Terrassa, Barcelona, Spain and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.