Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins
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- STATUS
- Recruiting
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- End date
- Sep 20, 2023
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- participants needed
- 334
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- sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Summary
A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Description
The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.
The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Details
| Condition | Septicemia, bacteraemia, Sepsis and Septicemia, Bacteremia, Bacterial Infections, Bacterial Infection, blood poisoning |
|---|---|
| Treatment | Meropenem, Temocillin |
| Clinical Study Identifier | NCT04478721 |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Last Modified on | 20 October 2021 |
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