scholarly journals Randomized controlled trial of nebulized colistimethate sodium as adjunctive therapy of ventilator-associated pneumonia caused by Gram-negative bacteria

2010 ◽  
Vol 65 (12) ◽  
pp. 2645-2649 ◽  
Author(s):  
P. Rattanaumpawan ◽  
J. Lorsutthitham ◽  
P. Ungprasert ◽  
N. Angkasekwinai ◽  
V. Thamlikitkul
Keyword(s):  
Randomized Controlled Trial ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
Gram Negative Bacteria ◽  
Ventilator Associated Pneumonia ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Colistimethate Sodium

scholarly journals DECOLONIZATION OF INTESTINAL CARRIAGE OF MDR/XDR GRAM-NEGATIVE BACTERIA WITH ORAL COLISTIN IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2018 ◽  
Vol 10 (1) ◽  
pp. 2018030 ◽  
Author(s):  
Igor Stoma ◽  
Igor Karpov ◽  
Igor Iskrov ◽  
Svetlana Krivenko ◽  
Anatoly Uss ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Rank Test ◽  
Control Group ◽  
Gram Negative Bacteria ◽  
Intestinal Colonization ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Increased Risk

BackgroundIntestinal colonization by MDR/XDR gram-negative bacteria leads to an increased risk of subsequent bloodstream infections (BSI) in patients receiving chemotherapy as a treatment for hematologic malignancies.ObjectivesThe objective of this study was to evaluate the efficacy of oral colistin in eradicating the intestinal carriage of MDR/XDR Gram-negative bacteria in patients with hematological malignancies.MethodsIn a tertiary hematology center adult patients with intestinal colonization by MDR/XDR Gram-negative bacteria were included in a randomized controlled trial (RCT) during a period from November 2016 to October 2017. Patients were treated with oral colistin for 14 days or observed with the primary outcome set as a decolonization on day 21 post-treatment. Secondary outcomes included treatment safety and changes in MICs of isolated microorganisms. ClinicalTrials.gov Identifier: NCT02966457.ResultsShort-time positive effect (61.3% vs 32.3%; OR 3.32; 95% CI 1.17–9.44; p=0.0241) was demonstrated on the day 14 of colistin treatment, without any statistical difference on day 21 post-treatment. The incidence of BSI in decolonization group was lower in the first 30 days after the intervention (3.2% vs 12.9%), but overall in the 90-day observation period it did not show any advantages comparing to control group (log-rank test; p=0.4721). No serious adverse effects or increase in resistance to colistin was observed.ConclusionsThis study suggests that in hematological patients the strategy of selective intestinal decolonization by colistin may be beneficial to decrease the rate of MDR/XDR Gram-negative intestinal colonization and the risk of BSI in the short-term period, having no long-term sustainable effects.

scholarly journals Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria: relevance to external validity

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Vered Daitch ◽  
Mical Paul ◽  
George L. Daikos ◽  
Emanuele Durante-Mangoni ◽  
Dafna Yahav ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
External Validity ◽  
Controlled Trial ◽  
Gram Negative Bacteria ◽  
Clinical Failure ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Carbapenem Resistant ◽  
Study Results ◽  
Refusal To Participate

Abstract Background Population external validity is the extent to which an experimental study results can be generalized from a specific sample to a defined population. In order to apply the results of a study, we should be able to assess its population external validity. We performed an investigator-initiated randomized controlled trial (RCT) (AIDA study), which compared colistin-meropenem combination therapy to colistin monotherapy in the treatment of patients infected with carbapenem-resistant Gram-negative bacteria. In order to examine the study’s population external validity and to substantiate the use of AIDA study results in clinical practice, we performed a concomitant observational trial. Methods The study was conducted between October 1st, 2013 and January 31st, 2017 (during the RCTs recruitment period) in Greece, Israel and Italy. Patients included in the observational arm of the study have fulfilled clinical and microbiological inclusion criteria but were excluded from the RCT due to receipt of colistin for > 96 h, refusal to participate, or prior inclusion in the RCT. Non-randomized cases were compared to randomized patients. The primary outcome was clinical failure at 14 days of infection onset. Results Analysis included 701 patients. Patients were infected mainly with Acinetobacter baumannii [78.2% (548/701)]. The most common reason for exclusion was refusal to participate [62% (183/295)]. Non-randomized and randomized patients were similar in most of the demographic and background parameters, though randomized patients showed minor differences towards a more severe infection. Combination therapy was less common in non-randomized patients [31.9% (53/166) vs. 51.2% (208/406), p = 0.000]. Randomized patients received longer treatment of colistin [13 days (IQR 10–16) vs. 8.5 days (IQR 0–15), p = 0.000]. Univariate analysis showed that non-randomized patients were more inclined to clinical failure on day 14 from infection onset [82% (242/295) vs. 75.5% (307/406), p = 0.042]. After adjusting for other variables, non-inclusion was not an independent risk factor for clinical failure at day 14. Conclusion The similarity between the observational arm and RCT patients has strengthened our confidence in the population external validity of the AIDA trial. Adding an observational arm to intervention studies can help increase the population external validity and improve implementation of study results in clinical practice. Trial registration The trial was registered with ClinicalTrials.gov, number NCT01732250 on November 22, 2012.

Impact of a Vancomycin-Induced Shift of the Gut Microbiome in a Gram-Negative Direction on Plasma Factor VIII:C Levels: Results from a Randomized Controlled Trial

2021 ◽  
Author(s):  
Gro Grimnes ◽  
Soerajja Bhoelan ◽  
Kristian Hindberg ◽  
Mark Davids ◽  
Max Nieuwdorp ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Systemic Inflammation ◽  
Complement Activation ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Gram Negative Bacteria ◽  
Gram Negative ◽  
Negative Direction ◽  
Randomized Controlled ◽  
Plasma Factor

Abstract Rationale Inflammation is present in several conditions associated with risk of venous thromboembolism. The gut microbiome might be a source of systemic inflammation and activation of coagulation, by translocation of lipopolysaccharides from gram-negative bacteria to the systemic circulation. Objective To investigate whether a vancomycin-induced shift of the gut microbiome in a gram-negative direction influences systemic inflammation and plasma factor (F) VIII procoagulant activity (FVIII:C). Methods and Results We performed a randomized controlled trial including 43 healthy volunteers aged 19 to 37 years. Twenty-one were randomized to 7 days of oral vancomycin intake and 22 served as controls. Feces and blood were sampled at baseline, the day after the end of intervention, and 3 weeks after intervention. Gut microbiome composition was assessed by amplicon sequencing. FVIII:C was measured using an activated partial thromboplastin time-based assay, cytokines were measured using multiplex technology, complement activation was measured using the enzyme-linked immunosorbent assay, and high-sensitivity C-reactive protein (CRP) was measured by an immunoturbidimetric assay. Vancomycin intake reduced gut microbiome diversity and increased the abundance of gram-negative bacteria. Change in FVIII:C in the intervention group was +4 IU/dL versus −6 IU/dL (p = 0.01) in the control group. A similar change was observed for log-transformed CRP (+0.21 mg/dL vs. −0.25 mg/dL, p = 0.04). The cytokines and complement activation markers remained similar in the two groups. Conclusion The found slight increases in FVIII:C and CRP levels might support the hypothesis that a vancomycin-induced gram-negative shift in the gut microbiome could induce increased systemic inflammation and thereby a procoagulant state.

Probiotic prophylaxis to prevent ventilator associated pneumonia (VAP) in children on mechanical ventilation: an open-label randomized controlled trial

2015 ◽  
Vol 41 (4) ◽  
pp. 677-685 ◽  
Author(s):  
Balasubramaniam Banupriya ◽  
Niranjan Biswal ◽  
Rangan Srinivasaraghavan ◽  
Parameswaran Narayanan ◽  
Jharna Mandal
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Ventilator Associated Pneumonia ◽  
Open Label ◽  
Randomized Controlled
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