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The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.
Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.
Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.
The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.
To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 days course of antibiotic treatment | Experimental | Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. |
|
| 14 days course of antibiotic treatment | Active Comparator | Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 days course of antibiotic treatment | Other | Standard antibiotic treatment approved for enterobacteraciae infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days of antimicrobial treatment | To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions related to antimicrobial treatment | To prove that 7-days course of antibiotic therapy is as safe as a 14-days course in terms of : Rate of adverse effects including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile, mortality, relapse of the infection | 28 days |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Molina Gil-Bermejo, MD. PhD | Hospitales Universitarios Virgen del Rocío | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Reina Sofía | Córdoba | Córdoba | 14004 | Spain | ||
| Universitary Hospital Málaga |
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| Label | URL |
|---|---|
| This organization is formed by 16 Spanish leading research groups in the field, is public funded by Spanish Carlos III Institute and co-financed by European Development Regional Fund (ERDF) | View source |
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Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.
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| 14 days course of antibiotic treatment | Other | Standard antibiotic treatment approved for enterobacteraciae infections |
|
|
| Cure of bacteremia |
Clinical and microbiological cure |
| 28 days |
| Procalcitonin levels | To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia | 7-days and 14-days |
| Málaga |
| Málaga |
| 29010 |
| Spain |
| University Hospital Virgen Macarena | Seville | Seville | 41007 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D018805 | Sepsis |
| D016470 | Bacteremia |
| D012008 | Recurrence |
| D000084063 | Reinfection |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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