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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003847-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Spanish Clinical Research Network - SCReN | NETWORK |
| Centers for International Business Education and Research | OTHER |
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Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).
The project is designed to determine the optimal duration of antibiotic treatment for Pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives.
Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose.
Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment.
This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-treatment of any active antibiotic regimen | Experimental | 7 days of any active antibiotic treatment from the date of the last positive blood culture |
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| Long-treatment of any active antibiotic regimen | Active Comparator | 14 days of any active antibiotic treatment from the date of the last positive blood culture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-treatment of any active antibiotic regimen | Drug | 7 days of any active antibiotic treatment for BSI-PA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group | Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps:
Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment. | 30 days after treatment withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority secondary endpoint; Treatment failure | Defined as mortality from any cause or proven/probable recurrence | Day +30 from trial treatment interruption |
| Recurrence of infection | Proven, probable or possible recurrence rate |
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Miguel Cisneros Herreros, MD-PhD | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain | ||
| Hospital Universitario de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36548225 | Background | Molina J, Rosso-Fernandez CM, Montero-Mateos E, Pano-Pardo JR, Solla M, Guisado-Gil AB, Alvarez-Marin R, Pachon-Ibanez ME, Gimeno A, Martin-Gutierrez G, Lepe JA, Cisneros JM; SHORTEN-2 trial team. Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial). PLoS One. 2022 Dec 22;17(12):e0277333. doi: 10.1371/journal.pone.0277333. eCollection 2022. |
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Final database containing only anonymous data from participant subjects will be shared with direct investigators in a timeframe of 6 months after the complete depuration
6 months
Direct collaborators within the study
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Parallel Assignment Randomized 1:1 to experimental group (short-treatment arm):control group (long-treatment arm)
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| Long-treatment of any active antibiotic regimen | Drug | 14 days of any active antibiotic treatment for BSI-PA |
|
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| Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| Mortality from any cause | Number of patients who died from any cause from the date of inclusion to the final follow-up period | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| Describe the superinfections | Superinfection rate | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| Safety of antibiotic treatment | Gathering any related adverse event from the informed consent form signature up to 90 days | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture and weighted by 1,000 days of follow-up. |
| Efficiency of the short-treatment arm | Number of days of treatment and days of hospital stay avoided at the end of the follow-up period | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| Confirmation of origin of recurrences | Checking if the recurrences are due to the same strain, comparing the P. aeruginosa strains by genetic sequencing | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| Comparison of ecological impact of short and long treatment regimens | Diversity of the gut microbiota analysis | Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture. |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Hospital Universitario Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario de Cruces | Barakaldo | Bizkaia | 48903 | Spain |
| Hospital Universitario de Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Universitario de Puerto Real | Puerto Real | Cádiz | 11510 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29603 | Spain |
| Clínica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complexo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36213 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario de A Coruña | A Coruña | 15006 | Spain |
| Hospital General Universitario Dr. Balmis | Alicante | 03010 | Spain |
| Complejo Hospitalario Torrecárdenas | Almería | 04009 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario Clínico San Cecilio | Granada | 18016 | Spain |
| Hospital Universitario Juan Ramón Jiménez | Huelva | 21005 | Spain |
| Complejo Hospitalario Ciudad de Jaén | Jaén | 23007 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Regional de Málaga | Málaga | 29010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario La Fe | Valencia | 46026 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Hospital Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D016470 | Bacteremia |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D016905 | Gram-Negative Bacterial Infections |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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