Archive for June 18, 2017

Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial.

Trials. 2015 Oct 9;16:450.                         

Kaasch AJ1, Fätkenheuer G2,3, Prinz-Langenohl R4, Paulus U5, Hellmich M6, Weiß V7, Jung N8, Rieg S9, Kern WV10, Seifert H11,12; SABATO trial group (with linked authorship to the individuals in the Acknowledgements section).

Collaborators (52)

Author information

Abstract

BACKGROUND:

Current guidelines recommend that patients with Staphylococcus aureus bloodstream infection (SAB) are treated with long courses of intravenous antimicrobial therapy. This serves to avoid SAB-related complications such as relapses, local extension and distant metastatic foci. However, in certain clinical scenarios, the incidence of SAB-related complications is low. Patients with a low-risk for complications may thus benefit from an early switch to oral medication through earlier discharge and fewer complications of intravenous therapy. The major objective for the SABATO trial is to demonstrate that in patients with low-risk SAB a switch from intravenous to oral antimicrobial therapy (oral switch therapy, OST) is non-inferior to a conventional course of intravenous therapy (intravenous standard therapy, IST).

METHODS/DESIGN:

The trial is designed as randomized, parallel-group, observer-blinded, clinical non-inferiority trial. The primary endpoint is the occurrence of a SAB-related complication (relapsing SAB, deep-seated infection, and attributable mortality) within 90 days. Secondary endpoints are the length of hospital stay; 14-day, 30-day, and 90-day mortality; and complications of intravenous therapy. Patients with SAB who have received 5 to 7 full days of adequate intravenous antimicrobial therapy are eligible. Main exclusion criteria are polymicrobial bloodstream infection, signs and symptoms of complicated SAB (deep-seated infection, hematogenous dissemination, septic shock, and prolonged bacteremia), the presence of a non-removable foreign body, and severe comorbidity. Patients will receive either OST or IST with a protocol-approved antimicrobial and are followed up for 90 days. Four hundred thirty patients will be randomized 1:1 in two study arms. Efficacy regarding incidence of SAB-related complications is tested sequentially with a non-inferiority margin of 10 and 5 percentage points.

DISCUSSION:

The SABATO trial assesses whether early oral switch therapy is safe and effective for patients with low-risk SAB. Regardless of the result, this pragmatic trial will strongly influence the standard of care in SAB.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01792804 registered 13 February 2013; German Clinical trials register DRKS00004741 registered 4 October 2013, EudraCT 2013-000577-77 . First patient randomized on 20 December 2013.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4600306/pdf/13063_2015_Article_973.pdf

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June 18, 2017 at 7:51 pm

Antibiotic prescription strategies and adverse outcome for uncomplicated lower respiratory tract infections: Prospective cough complication cohort (3C) study.

BMJ May 22, 2017 V.357 P.j2148.   

Little P et al.

PDF

http://www.bmj.com/content/bmj/357/bmj.j2148.full.pdf

June 18, 2017 at 7:04 pm

Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary.

Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582.

Vogelmeier CF1, Criner GJ2, Martinez FJ3, Anzueto A4,5, Barnes PJ6, Bourbeau J7, Celli BR8, Chen R9, Decramer M10, Fabbri LM11, Frith P12, Halpin DM13, López Varela MV14, Nishimura M15, Roche N16, Rodriguez-Roisin R17, Sin DD18, Singh D19, Stockley R20, Vestbo J19, Wedzicha JA6, Agustí A21.

Author information

1 1 University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.

2 2 Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.

3 3 New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York.

4 4 University of Texas Health Science Center, San Antonio, Texas.

5 5 South Texas Veterans Health Care System, San Antonio, Texas.

6 6 National Heart and Lung Institute, Imperial College, London, United Kingdom.

7 7 McGill University Health Centre, McGill University, Montreal, Quebec, Canada.

8 8 Brigham and Women’s Hospital, Boston, Massachusetts.

9 9 State Key Lab for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

10 10 University of Leuven, Leuven, Belgium.

11 11 University of Modena and Reggio Emilia, Modena, Italy.

12 12 Faculty of Medicine, Flinders University, Bedford Park, South Australia, Australia.

13 13 Royal Devon and Exeter Hospital, Exeter, United Kingdom.

14 14 Universidad de la República, Hospital Maciel, Montevideo, Uruguay.

15 15 Hokkaido University School of Medicine, Sapporo, Japan.

16 16 Hôpital Cochin (Assistance Publique-Hôpitaux de Paris), University Paris Descartes, Paris, France.

17 17 Thorax Institute, Hospital Clinic Universitat de Barcelona, Barcelona, Spain.

18 18 St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada.

19 19 University of Manchester, Manchester, United Kingdom.

20 20 University Hospital, Birmingham, United Kingdom; and.

21 21 Hospital Clínic, Universitat de Barcelona, Centro de Investigación Biomédica en Red de Enfermedade Respiratorias, Barcelona, Spain.

Abstract

This Executive Summary of the Global Strategy for the Diagnosis, Management, and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 report focuses primarily on the revised and novel parts of the document. The most significant changes include:

(1) the assessment of chronic obstructive pulmonary disease has been refined to separate the spirometric assessment from symptom evaluation. ABCD groups are now proposed to be derived exclusively from patient symptoms and their history of exacerbations;

(2) for each of the groups A to D, escalation strategies for pharmacologic treatments are proposed;

(3) the concept of deescalation of therapy is introduced in the treatment assessment scheme;

(4) nonpharmacologic therapies are comprehensively presented; and

(5) the importance of comorbid conditions in managing chronic obstructive pulmonary disease is reviewed.

PDF

http://www.atsjournals.org/doi/abs/10.1164/rccm.201701-0218PP?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed#readcube-epdf

June 18, 2017 at 4:18 pm


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