Chart Review for Antibiotics Causing Adverse Effects in Therapeutic Use

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Boston Healthcare System, Boston, MA
Antibiotics Causing Adverse Effects in Therapeutic Use
Chart Review - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can improve compliance with guidelines for CIED procedures.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Antibiotics Causing Adverse Effects in Therapeutic Use

Study Objectives

This trial is evaluating whether Chart Review will improve 5 primary outcomes in patients with Antibiotics Causing Adverse Effects in Therapeutic Use. Measurement will happen over the course of 1 day.

1 day
Pre-procedure Antimicrobial Use
14 days
Post-procedure Antimicrobial Use
7 days
Acute Kidney Injury (AKI)
90 days
C. difficile infections
cardiac device infection

Trial Safety

Safety Progress

1 of 3

Other trials for Antibiotics Causing Adverse Effects in Therapeutic Use

Trial Design

1 Treatment Group

Cardiac Device Cohort
1 of 1
Experimental Treatment

This trial requires 100000 total participants across 1 different treatment group

This trial involves a single treatment. Chart Review is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Cardiac Device Cohort
Other
This study is open to any adult VA patient with data about a cardiac device procedure performed in the electrophysiology laboratory entered into the national VA EHR. During FY 20-FY 24, we anticipate that this will include approximately 9,000 patients per year, or a total of 50,000 patients. In addition, cases that were previously accessed and used to develop the infection monitoring system, and the quality metric monitoring system, may also be included. This includes all patients entered in the VA Clinical Assessment Reporting and Tracking - Electrophysiology Cohort (CART-EP) database during the period from 2006-2016, and all VA patients who received a cardiac device procedure during the period from 2010-2019. This includes another approximately 50,000 patients, for a total of 100,000 patients.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Who is running the study

Principal Investigator
W. B.
Prof. Westyn Branch-Elliman, Assistant Professor of Medicine
VA Boston Healthcare System

Closest Location

VA Boston Healthcare System - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This study is open to any adult VA patient with data about a cardiac device procedure performed in the electrophysiology laboratory entered into the national VA EHR.

Patient Q&A Section

What is antibiotics causing adverse effects in therapeutic use?

"Results from a recent paper suggest that caution must be used before prescribing to patients on antibiotics the following drugs: ampicillin, enepenem, gentamicin, levofloxacin, meropenem, piperacillin/tazobactam, quinolones, and ciprofloxacin." - Anonymous Online Contributor

Unverified Answer

What causes antibiotics causing adverse effects in therapeutic use?

"This review highlights the significant morbidity and the poor outcomes of antibiotics causative adverse effects in therapeutic use. The need for improved strategies to control these severe consequences is stressed out. The main issues remain to ensure compliance, to identify the underlying mechanisms and to establish guidelines for rational use of these precious drugs." - Anonymous Online Contributor

Unverified Answer

What are the signs of antibiotics causing adverse effects in therapeutic use?

"The authors discuss some signs of possible side effects of antibiotics, including those observed under therapy and those associated with an increased risk for adverse effects in the post-therapy scenario." - Anonymous Online Contributor

Unverified Answer

What are common treatments for antibiotics causing adverse effects in therapeutic use?

"The use of antibiotics has become more widespread in our environments, so we need to implement more efficient methods and methods of treatment. One of them is to reduce doses by adjusting the antimicrobial prescriptions." - Anonymous Online Contributor

Unverified Answer

Can antibiotics causing adverse effects in therapeutic use be cured?

"When a drug causing an adverse effect in the therapeutic use in a patient is known, it should be discontinued, and when this has a low risk, it can be used with caution. The use of antibiotics in those with infectious diseases and those that are unlikely to respond to antibiotics in the therapeutic use has a high risk because it is associated with a very high risk of adverse effects." - Anonymous Online Contributor

Unverified Answer

How many people get antibiotics causing adverse effects in therapeutic use a year in the United States?

"About 1.2 million people will be hospitalized in the United States for adverse effects of antibiotics in 2014. However, the majority (717,000) of these people will not be hospitalized because of adverse drug reactions (ADRs) that will be observed in primary care or pharmacies. Approximately 0.4 million people will be hospitalized for ADRs from the use of antibiotics in hospitals (i.e., hospital-acquired ADRs). This information should help physicians and parents make informed decisions about what to do when these patients receive prescriptions for antibiotics." - Anonymous Online Contributor

Unverified Answer

What does chart review usually treat?

"The data from this study provides baseline evidence for a guideline to recommend that patients with uncomplicated community-acquired pneumonia with normal vital signs and no evidence of pulmonary consolidation or evidence of sepsis should be treated with short courses of antibiotics, without a clinical trial." - Anonymous Online Contributor

Unverified Answer

How serious can antibiotics causing adverse effects in therapeutic use be?

"All kinds of antibiotics, such as beta-lactam antibiotics, glycopeptides, quinolones, and fluoroquinolones, could cause severe adverse effects in therapeutic use. It is very important to know the risk of toxicity when selecting antibiotics for clinical use. We can also reduce the risk when we decide the doses and use them cautiously." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for antibiotics causing adverse effects in therapeutic use?

"Most general patients with stable rheumatic diseases and other non-severe health conditions may benefit from clinical trials evaluating the role of antibiotics in the short term. Also, patients with prior exposure to antibiotics should not be denied such studies but, according to our results, it is appropriate for patients who are candidates for antibiotics in therapeutic use to be included in such clinical trials." - Anonymous Online Contributor

Unverified Answer

Does chart review improve quality of life for those with antibiotics causing adverse effects in therapeutic use?

"Chart review reduces adverse effects in therapeutic use. The quality of life of patients treated in hospital is less than it would be if they did not have this issue." - Anonymous Online Contributor

Unverified Answer

What is the latest research for antibiotics causing adverse effects in therapeutic use?

"The study presented here shows evidence for an increasing number of antibiotics causing ADEs in patients treated with them. Data from a recent study suggests the need for an ongoing and more focused effort to identify the antibiotics causing most unwanted ADEs." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving chart review?

"We conclude that such a record review is a feasible and efficient method of improving patient safety. However, the limited available evidence on our study highlights the difficulty of evaluating drug treatment for acute appendicitis in such trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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