Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis

Iversen, Kasper; Ihlemann, Nikolaj; Gill, Sabine; Madsen, Trine; Elming, Hanne; Jensen, Kimmo; Bruun, Niels Eske; Høfsten, Dan Eik; Fursted, Kurt; Christensen, Jens Jørgen; Schultz, Martin; Klein, Christine Falk; Fosbøl, Emil Loldrup; Rosenvinge, Flemming Schønning; Schønheyder, Henrik Carl; Køber, Lars; Torp‐Pedersen, Christian; Helweg‐Larsen, Jannik; Tønder, Niels; Moser, Claus; Bundgaard, Henning

doi:10.1056/nejmoa1808312

Cited by 551 publications

(421 citation statements)

References 29 publications

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“…4). It is important to note that our 4% non-inferiority margin is already much smaller than the noninferiority margins used in recent trials of antibiotic treatment duration in patients with serious bacterial infections [12][13][14][15], and is also much lower than the US Federal Drug Administration recommendation of noninferiority margins for ventilator-associated pneumonia [16]. Therefore, we have opted to maintain our current overall sample size target (n = 3626) for the BALANCE main trial.…”

Section: Discussionmentioning

confidence: 99%

“…The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%, 95% CI 8.1-19.5%), which was similar to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%, 95% CI 9.4-22.4%) (p = 0.65; Table 3) and mortality estimates from the main BALANCE RCT as of 600 patients enrolled (104/600, 17.3%, 95% CI 14.5-20.6%). The patients in the BALANCE-Ward pilot had a shorter median (IQR) length of hospital stay (6 (4-12) vs 20(12-43) days, p < 0.001) and more antibiotic-free days by day 28 (14(14-21) vs 14 (8)(9)(10)(11)(12)(13)(14)(15)(16)(17), p < 0.0001) ( Table 3). Only one patient was lost to follow-up at 90 days, but there are ongoing efforts to ascertain final vital status for this patient.…”

Section: Clinical Outcomesmentioning

confidence: 99%

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A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Daneman¹,

Rishu

Pinto

et al. 2020

Trials

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Background: The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards. Methods:We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and noninferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients. Results: A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1-4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/ site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/ 134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models (Continued on next page)

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Section: Discussionmentioning

confidence: 99%

Section: Clinical Outcomesmentioning

confidence: 99%

A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Daneman¹,

Rishu

Pinto

et al. 2020

Trials

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“…There are, fortunately, also biofilm infections where antibiotic prophylactics and treatment are not so difficult e.g. endocarditis and successful antibiotic treatment can be obtained, even with orally administered antibiotics in stabilized patients after an initial intravenous course of appropriate antibiotic drugs .…”

Section: Special Situation Biofilm Infectionsmentioning

confidence: 99%

Antibiotic therapy as personalized medicine – general considerations and complicating factors

Moser

Lerche

Thomsen

et al. 2019

APMIS

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The discovery of antibiotic drugs is considered one of the previous century's most important medical discoveries (Medicine's 10 greatest discoveries. New Haven, CT: Yale University Press, 1998: 263). Appropriate use of antibiotics saves millions of lives each year and prevents infectious complications for numerous people. Still, infections kill unacceptable many people around the world, even in developed countries with easy access to most antibiotic drugs. Optimal use of antibiotics is dependent on the identification of primary and secondary focus, and knowledge on which pathogens to expect in a specific infectious syndrome and information on general patterns of regional antibiotic resistance. Furthermore, sampling for microbiological analysis, knowledge of patient immune status and organ functions, travel history, pharmacokinetics and ‐dynamics of the different antibiotics and possible biofilm formation are among several factors involved in antibiotic therapy of infectious diseases. The present review aims at describing important considerations when using antibacterial antibiotics and to describe how this is becoming substantially more personalized. The parameters relevant in considering the optimal use of antibiotics to treat infections are shown in Fig. 1 – leading to the most relevant antibiotic therapy for that specific patient. To illustrate this subject, the present review's focus will be on challenges with optimal dosing of antibiotics and risks of underdosing. Especially, in cases highly challenging for achieving the aimed antibiotic effect against bacterial infections – this includes augmented renal clearance (ARC) in sepsis, dosing challenges of antibiotics in pregnancy and against biofilm infections.

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“…This is especially the case with orally administered β‐lactams whose bioavailability and doses are much lower than their IV counterparts . However, studies showed that PO antibiotics are as effective as IV antibiotics for other difficult to treat infections including left‐sided endocarditis and bone‐joint infections …”

mentioning

confidence: 99%

Transition to Oral versus Continued Intravenous Antibiotics for Patients with Pyogenic Liver Abscesses: A Retrospective Analysis

2019

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Introduction The management of pyogenic liver abscesses usually requires 4 weeks of antibiotic therapy. It is unknown if oral (PO) antibiotics are as effective as intravenous (IV) antibiotics for this indication. Objectives To compare 30‐, 60‐, and 90‐day readmission rates between patients with pyogenic liver abscesses receiving IV antibiotics for the duration of therapy and those who were transitioned to PO antibiotics after discharge from the hospital. Methods This retrospective study included patients with pyogenic liver abscesses who had undergone percutaneous drainage and received IV antibiotics while in the hospital. Patients were grouped based on receipt of either PO or IV antibiotics at discharge. Results The final cohort resulted in 99 patients, 48 in the PO group and 51 in the IV group. The most common organisms identified were Klebsiella sp, Escherichia coli, and Streptococcus sp. The most common antibiotic received at discharge in the IV group was ertapenem or ceftriaxone plus metronidazole. Patients in the PO group most commonly received levofloxacin plus metronidazole at discharge. Thirty‐day readmission occurred more frequently in the PO group (PO 39.6% vs IV 17.6%, p=0.03). The most common reasons for readmission were complications related to abscess or antibiotic. Univariate logistic regression for readmission identified PO antibiotics at discharge as an independent predictor of readmission at 30 days (odds ratio [OR] 3.1), 60 days (OR 3.9), and 90 days (OR 3.1). Conclusion Transition to PO antibiotics that consisted mostly of fluoroquinolones for patients with pyogenic liver abscesses was associated with a higher rate of 30‐day readmission compared with patients treated with IV antibiotics that consisted mostly of β‐lactams.

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Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis

Cited by 551 publications

References 29 publications

A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Antibiotic therapy as personalized medicine – general considerations and complicating factors

Transition to Oral versus Continued Intravenous Antibiotics for Patients with Pyogenic Liver Abscesses: A Retrospective Analysis

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