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NCT03681431
Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective Endocarditis
Phase 2 trial testing Ceftriaxone 4g/ 24h in Infectious Endocarditis in 12 participants. Completed in 23 May 2019.
23 April 2019
Quick facts
| Lead sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 23 April 2018 |
| Primary completion | 23 April 2019 |
| Estimated completion | 23 May 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Ceftriaxone 4g/ 24h — full drug profile →
- Ceftriaxone 2g/ 12h — full drug profile →
Conditions studied
- Infectious Endocarditis — all drugs for Infectious Endocarditis →
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →
Who can join
Adults 18 to 100, any sex, with Infectious Endocarditis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical trial is designed as a phase II, crossover clinical trial. It will be carried out in healthy volunteers, who will receive two different antibiotic regimen based on ceftriaxone. One of the regimens had shown clinical effectiveness in this scenario, but it is not suitable for OPAT programs. In the other hand, a new treatment schema useful in OPAT programs is proposed, but there is still a lack of pharmacokinetic data to support it. The plasma drug concentrations will be measured in both cases, comparing the minimal drug concentration observed and the pharmacokinetic profiles of the two regimens.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03681431
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03681431 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Last refreshed: 3 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03681431.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing