BacteremiaPRO-BACNCT03148769
Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
An observational study of Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
Trial summary
Bacteremia The Hypothesis of the study are the followings: To demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia. Since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 5,320 participants
- Where
- 29 sitesSpain
- Study dates
- Oct 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: It will be included all episodes of bacteremia diagnosed over a year in all participating hospitals in patients over 13 years old. It´s no possible to make a calculation of the sample size, this will depend on the type of hospital, the number of beds of the same and the number of blood cultures that are requested during the period of recruitment of the study.
Who may be able to join
- Every episode of bacteremia in patients older than 13 years old, confirmed microbiologically and clinically significant (presence of clinical sepsis data at diagnosis) should be prospectively included on the basis of standard criteria.
- Episodes of transient bacteremia may be included.
- Drugs will be prescribed in the usual way, according to the conditions established in the authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include to the patient in the study.
Who cannot join
- Bacteremias without clinical relevance
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Hospital Punta Europa
Algeciras, Cádiz, 11207
University General Hospital of Alicante
Alicante, 03012
Torrecárdenas Hospital
Almería, 04009
L´ Esperit Sant ( Santa Coloma Granemet) Hospital
Barcelona, 08923
University Hospital of Burgos
Burgos, 09006
University Hospital Puerta del Mar
Cadiz, 11009
La Linea de la Concepción Hospital
Cadiz, 11300
Puerto Real Hospital
Cadiz, 11510
University Hospital Reina Sofía
Córdoba, 14004
Public Health Agency Business Hospital de Poniente.
El Ejido, Almería, 04700
University Hospital San Cecilio
Granada, 18012
University Hospital Virgen de las Nieves
Granada, 18014
General Hospital of Granollers
Granollers, Barcelona, 08402
Ciudad de Jaén Hospital
Jaén, 23007
Jerez de la Frontera Hospital
Jerez de la Frontera, Cádiz, 11138
University Hospital of León
León, 24001
University Hospital Arnau de Vilanova
Lleida, 25198
University Hospital Carlos Haya ( Málaga)
Málaga, 29010
Costa del Sol Hospital
Márbella, Málaga, 29603
Central University Hospital of Asturias
Oviedo, 33011
University Clinic of Navarra
Pamplona, 31008
Hospital El Bierzo
Ponferrada, León, 24404
University Hospital Marqués de Valdecilla
Santander, 30008
University Hospital Virgen Macarena
Seville, 41009
University Virgen de Valme Hospital
Seville, 41014
University Hospital Mútua de Terrasa
Terrassa, Barcelona, 08221
Hospital San Juan de la Cruz
Úbeda, Jaen, 23400
University Hospital of Vigo
Vigo, Pontevedra, 36204
Universitary Hospital Cruces
Vizcaya, 48903
About this study
Official title: Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.
Bacteremia
The Hypothesis of the study are the followings:
- To demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia.
- Since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve.
- To identify quality indicators in the management of bacteremia.
- To demonstrate that some interventions made by Bacteremia Team pose relevant impact in the prognosis of bacteremia.
- Conditions
- Bacteremia
- Keywords
- Bloodstream infections, epidemiology
- Medical subject headings
- Bacteremia, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology and prognostic factors of bacteremia episodes.
- Global incidence and per type of acquisition.
- Global etiology and per type of acquisition.
- Frequency of multiresistant and emerging microorganism.
- Source of bacteremia.
- Clinical severity of presentation.
- Clinical failure, mortality at day 7, mortality at day 30, recurrence, length of stay and re-admission at hospital.
Measured: From day 0 to day 30
Secondary outcomes (6)
Clinical management of patients with bacteremia during the episode.
- Antibiotic therapy used during the episodes (empirical and targeted).
- Non antibiotic therapy/support therapy used during the episode.
- Frequency of focus search and adequate control.
Measured: From day 0 to day 30
Differences in the management between types of services, wards and hospitals.
Comparison between different services and hospital wards of variables regarding on the management of episodes.
Measured: From day 0 to day 30
Influence of clinical management in the prognosis.
- Identifying prognostic factors related with mortality, clinical failure and recurrence.
Measured: From day 0 to day 30
Developing and validating a predictive model for early and late mortality.
- Developing and validating a predictive model for mortality based in prognostic factors related with mortality.
Measured: From day 0 to day 30
Quality indicators in the management of bacteremia.
- Identifying quality indicators in the management of episodes of bacteremia.
Measured: From day 0 to day 30
Interventions made by Bacteremia Team.
- Frequency and type of interventions made by Bacteremia Teams.
- Impact of these interventions in the management and prognosis of episodes.
Measured: From day 0 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startOct 2016
- Primary completionMay 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Sponsor
- Investigators
- Jesús Rodríguez-Baño, MD PhD, Study director, Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148769
- Sponsor's protocol ID
- FIS-AMO-2016-01
- Acronym
- PRO-BAC
- Status last verified
- May 2019
- First submitted
- 5 Apr 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garnacho-Montero J, Garcia-Garmendia JL, Barrero-Almodovar A, Jimenez-Jimenez FJ, Perez-Paredes C, Ortiz-Leyba C. Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis. Crit Care Med. 2003 Dec;31(12):2742-51. doi: 10.1097/01.CCM.0000098031.24329.10.
PubMed 14668610Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
PubMed 16424713Rodriguez-Bano J, Lopez-Prieto MD, Portillo MM, Retamar P, Natera C, Nuno E, Herrero M, del Arco A, Munoz A, Tellez F, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, Leon L, Perez-Lopez JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x.
PubMed 19845694Lopez-Cortes LE, Del Toro MD, Galvez-Acebal J, Bereciartua-Bastarrica E, Farinas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martinez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodriguez-Bano J; REIPI/SAB group. Impact of an evidence-based bundle intervention in the quality-of-care management and outcome of Staphylococcus aureus bacteremia. Clin Infect Dis. 2013 Nov;57(9):1225-33. doi: 10.1093/cid/cit499. Epub 2013 Aug 8.
PubMed 23929889Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.
PubMed 19191635Rodriguez-Bano J, Pano-Pardo JR, Alvarez-Rocha L, Asensio A, Calbo E, Cercenado E, Cisneros JM, Cobo J, Delgado O, Garnacho-Montero J, Grau S, Horcajada JP, Hornero A, Murillas-Angoiti J, Oliver A, Padilla B, Pasquau J, Pujol M, Ruiz-Garbajosa P, San Juan R, Sierra R; Grupo de Estudio de la Infeccion Hospitalaria-Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica; Sociedad Espanola de Farmacia Hospitalaria; Sociedad Espanola de Medicina Preventiva, Salud Publica e Higiene. [Programs for optimizing the use of antibiotics (PROA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document]. Enferm Infecc Microbiol Clin. 2012 Jan;30(1):22.e1-22.e23. doi: 10.1016/j.eimc.2011.09.018. Epub 2011 Dec 15. Spanish.
PubMed 22178010Mosier MJ, Ton-That H. Making the case for de-escalation therapy in ventilator-associated pneumonia once again. Crit Care Med. 2013 Jul;41(7):1810-1. doi: 10.1097/CCM.0b013e31828ce949. No abstract available.
PubMed 23774344Kaye KS. Antimicrobial de-escalation strategies in hospitalized patients with pneumonia, intra-abdominal infections, and bacteremia. J Hosp Med. 2012;7 Suppl 1:S13-21. doi: 10.1002/jhm.983.
PubMed 23737333Gaynes R. Health care--associated bloodstream infections: a change in thinking. Ann Intern Med. 2002 Nov 19;137(10):850-1. doi: 10.7326/0003-4819-137-10-200211190-00015. No abstract available.
PubMed 12435223Cisneros-Herreros JM, Sanchez-Gonzalez M, Prados-Blanco MT, Llanos-Rodriguez C, Vigil-Martin E, Soto-Espinosa de los Monteros B, Pachon-Diaza J. [Blood cultures in the emergency department]. Enferm Infecc Microbiol Clin. 2005 Mar;23(3):135-9. doi: 10.1157/13072162. Spanish.
PubMed 15757584Fridkin SK, Hageman JC, Morrison M, Sanza LT, Como-Sabetti K, Jernigan JA, Harriman K, Harrison LH, Lynfield R, Farley MM; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Methicillin-resistant Staphylococcus aureus disease in three communities. N Engl J Med. 2005 Apr 7;352(14):1436-44. doi: 10.1056/NEJMoa043252.
PubMed 15814879Rodriguez-Bano J, Navarro MD, Romero L, Martinez-Martinez L, Muniain MA, Perea EJ, Perez-Cano R, Pascual A. Epidemiology and clinical features of infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in nonhospitalized patients. J Clin Microbiol. 2004 Mar;42(3):1089-94. doi: 10.1128/JCM.42.3.1089-1094.2004.
PubMed 15004058Al-Hasan MN, Juhn YJ, Bang DW, Yang HJ, Baddour LM. External validation of bloodstream infection mortality risk score in a population-based cohort. Clin Microbiol Infect. 2014 Sep;20(9):886-91. doi: 10.1111/1469-0691.12607. Epub 2014 Mar 26.
PubMed 25455590Al-Hasan MN, Lahr BD, Eckel-Passow JE, Baddour LM. Predictive scoring model of mortality in Gram-negative bloodstream infection. Clin Microbiol Infect. 2013 Oct;19(10):948-54. doi: 10.1111/1469-0691.12085. Epub 2012 Nov 27.
PubMed 23190091Retamar P, Portillo MM, Lopez-Prieto MD, Rodriguez-Lopez F, de Cueto M, Garcia MV, Gomez MJ, Del Arco A, Munoz A, Sanchez-Porto A, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Garcia-Figueras C, Acosta F, Corzo JE, Leon-Ruiz L, Escobar-Lara T, Rodriguez-Bano J; SAEI/SAMPAC Bacteremia Group. Impact of inadequate empirical therapy on the mortality of patients with bloodstream infections: a propensity score-based analysis. Antimicrob Agents Chemother. 2012 Jan;56(1):472-8. doi: 10.1128/AAC.00462-11. Epub 2011 Oct 17.
PubMed 22005999
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.
- ClinicalTrials.gov ID
- NCT03148769
- Acronym / sponsor ID
- PRO-BAC / FIS-AMO-2016-01
- Conditions
- Bacteremia
- Keywords
- Bloodstream infections, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,320 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacteremia
The Hypothesis of the study are the followings:
- To demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia.
- Since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve.
- To identify quality indicators in the management of bacteremia.
- To demonstrate that some interventions made by Bacteremia Team pose relevant impact in the prognosis of bacteremia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It will be included all episodes of bacteremia diagnosed over a year in all participating hospitals in patients over 13 years old. It´s no possible to make a calculation of the sample size, this will depend on the type of hospital, the number of beds of the same and the number of blood cultures that are requested during the period of recruitment of the study.
Key inclusion criteria (3 listed)
- Every episode of bacteremia in patients older than 13 years old, confirmed microbiologically and clinically significant (presence of clinical sepsis data at diagnosis) should be prospectively included on the basis of standard criteria.
- Episodes of transient bacteremia may be included.
- Drugs will be prescribed in the usual way, according to the conditions established in the authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include to the patient in the study.
Key exclusion criteria (1 listed)
- Bacteremias without clinical relevance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology and prognostic factors of bacteremia episodes.
Time frame: From day 0 to day 30
* Global incidence and per type of acquisition. * Global etiology and per type of acquisition. * Frequency of multiresistant and emerging microorganism. * Source of bacteremia. * Clinical severity of presentation. * Clinical failure, mortality at day 7, mortality at day 30, recurrence, length of stay and re-admission at hospital.
6 secondary outcomes
Clinical management of patients with bacteremia during the episode.
Time frame: From day 0 to day 30
Differences in the management between types of services, wards and hospitals.
Time frame: From day 0 to day 30
Influence of clinical management in the prognosis.
Time frame: From day 0 to day 30
Developing and validating a predictive model for early and late mortality.
Time frame: From day 0 to day 30
Quality indicators in the management of bacteremia.
Time frame: From day 0 to day 30
Interventions made by Bacteremia Team.
Time frame: From day 0 to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Results publication: PubMed 14668610Garnacho-Montero J, Garcia-Garmendia JL, Barrero-Almodovar A, Jimenez-Jimenez FJ, Perez-Paredes C, Ortiz-Leyba C. Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis. Crit Care Med. 2003 Dec;31(12):2742-51. doi: 10.1097/01.CCM.0000098031.24329.10.
- Results publication: PubMed 16424713Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
- Results publication: PubMed 19845694Rodriguez-Bano J, Lopez-Prieto MD, Portillo MM, Retamar P, Natera C, Nuno E, Herrero M, del Arco A, Munoz A, Tellez F, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, Leon L, Perez-Lopez JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x.
- Results publication: PubMed 23929889Lopez-Cortes LE, Del Toro MD, Galvez-Acebal J, Bereciartua-Bastarrica E, Farinas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martinez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodriguez-Bano J; REIPI/SAB group. Impact of an evidence-based bundle intervention in the quality-of-care management and outcome of Staphylococcus aureus bacteremia. Clin Infect Dis. 2013 Nov;57(9):1225-33. doi: 10.1093/cid/cit499. Epub 2013 Aug 8.
- Results publication: PubMed 19191635Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.
- Results publication: PubMed 22178010Rodriguez-Bano J, Pano-Pardo JR, Alvarez-Rocha L, Asensio A, Calbo E, Cercenado E, Cisneros JM, Cobo J, Delgado O, Garnacho-Montero J, Grau S, Horcajada JP, Hornero A, Murillas-Angoiti J, Oliver A, Padilla B, Pasquau J, Pujol M, Ruiz-Garbajosa P, San Juan R, Sierra R; Grupo de Estudio de la Infeccion Hospitalaria-Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica; Sociedad Espanola de Farmacia Hospitalaria; Sociedad Espanola de Medicina Preventiva, Salud Publica e Higiene. [Programs for optimizing the use of antibiotics (PROA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document]. Enferm Infecc Microbiol Clin. 2012 Jan;30(1):22.e1-22.e23. doi: 10.1016/j.eimc.2011.09.018. Epub 2011 Dec 15. Spanish.
- Results publication: PubMed 23774344Mosier MJ, Ton-That H. Making the case for de-escalation therapy in ventilator-associated pneumonia once again. Crit Care Med. 2013 Jul;41(7):1810-1. doi: 10.1097/CCM.0b013e31828ce949. No abstract available.
- Results publication: PubMed 23737333Kaye KS. Antimicrobial de-escalation strategies in hospitalized patients with pneumonia, intra-abdominal infections, and bacteremia. J Hosp Med. 2012;7 Suppl 1:S13-21. doi: 10.1002/jhm.983.
- Results publication: PubMed 12435223Gaynes R. Health care--associated bloodstream infections: a change in thinking. Ann Intern Med. 2002 Nov 19;137(10):850-1. doi: 10.7326/0003-4819-137-10-200211190-00015. No abstract available.
- Results publication: PubMed 15757584Cisneros-Herreros JM, Sanchez-Gonzalez M, Prados-Blanco MT, Llanos-Rodriguez C, Vigil-Martin E, Soto-Espinosa de los Monteros B, Pachon-Diaza J. [Blood cultures in the emergency department]. Enferm Infecc Microbiol Clin. 2005 Mar;23(3):135-9. doi: 10.1157/13072162. Spanish.
- Results publication: PubMed 15814879Fridkin SK, Hageman JC, Morrison M, Sanza LT, Como-Sabetti K, Jernigan JA, Harriman K, Harrison LH, Lynfield R, Farley MM; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Methicillin-resistant Staphylococcus aureus disease in three communities. N Engl J Med. 2005 Apr 7;352(14):1436-44. doi: 10.1056/NEJMoa043252.
- Results publication: PubMed 15004058Rodriguez-Bano J, Navarro MD, Romero L, Martinez-Martinez L, Muniain MA, Perea EJ, Perez-Cano R, Pascual A. Epidemiology and clinical features of infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in nonhospitalized patients. J Clin Microbiol. 2004 Mar;42(3):1089-94. doi: 10.1128/JCM.42.3.1089-1094.2004.
- European Surveillance of Antimicrobial Consumption Network (ESAC-Net).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Rodríguez-Baño, MD PhD study director
Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 29 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology and prognostic factors of bacteremia episodes. (time frame: From day 0 to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148769, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.