Treatment Outcomes of Colistin- and Carbapenem-resistant Acinetobacter baumannii Infections: An Exploratory Subgroup Analysis of a Randomized Clinical Trial

2018 ◽  
Vol 69 (5) ◽  
pp. 769-776 ◽  
Author(s):  
Yaakov Dickstein ◽  
Jonathan Lellouche ◽  
Maayan Ben Dalak Amar ◽  
David Schwartz ◽  
Amir Nutman ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Acinetobacter Baumannii ◽  
Bacterial Infections ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Mortality Rates ◽  
Colistin Resistance ◽  
Randomized Controlled ◽  
Carbapenem Resistant

Abstract Background We evaluated the association between mortality and colistin resistance in Acinetobacter baumannii infections and the interaction with antibiotic therapy. Methods This is a secondary analysis of a randomized controlled trial of patients with carbapenem-resistant gram-negative bacterial infections treated with colistin or colistin-meropenem combination. We evaluated patients with infection caused by carbapenem-resistant A. baumannii (CRAB) identified as colistin susceptible (CoS) at the time of treatment and compared patients in which the isolate was confirmed as CoS with those whose isolates were retrospectively identified as colistin resistant (CoR) when tested by broth microdilution (BMD). The primary outcome was 28-day mortality. Results Data were available for 266 patients (214 CoS and 52 CoR isolates). Patients with CoR isolates had higher baseline functional capacity and lower rates of mechanical ventilation than patients with CoS isolates. All-cause 28-day mortality was 42.3% (22/52) among patients with CoR strains and 52.8% (113/214) among patients with CoS isolates (P = .174). After adjusting for variables associated with mortality, the mortality rate was lower among patients with CoR isolates (odds ratio [OR], 0.285 [95% confidence interval {CI}, .118–.686]). This difference was associated with treatment arm: Mortality rates among patients with CoR isolates were higher in those randomized to colistin-meropenem combination therapy compared to colistin monotherapy (OR, 3.065 [95% CI, 1.021–9.202]). Conclusions Colistin resistance determined by BMD was associated with lower mortality among patients with severe CRAB infections. Among patients with CoR isolates, colistin monotherapy was associated with a better outcome compared to colistin-meropenem combination therapy. Clinical Trials Registration NCT01732250

Colistin Resistance Development Following Colistin-Meropenem Combination Therapy Versus Colistin Monotherapy in Patients With Infections Caused by Carbapenem-Resistant Organisms

2019 ◽  
Vol 71 (10) ◽  
pp. 2599-2607 ◽  
Author(s):  
Yaakov Dickstein ◽  
Jonathan Lellouche ◽  
David Schwartz ◽  
Amir Nutman ◽  
Nadya Rakovitsky ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Colistin Resistance ◽  
Primary Analysis ◽  
Resistance Development ◽  
Gram Negative ◽  
Carbapenem Resistant ◽  
Severe Infections ◽  
Gram Negative Organisms

Abstract Background We evaluated whether carbapenem-colistin combination therapy reduces the emergence of colistin resistance, compared to colistin monotherapy, when given to patients with infections due to carbapenem-resistant Gram-negative organisms. Methods This is a pre-planned analysis of a secondary outcome from a randomized, controlled trial comparing colistin monotherapy with colistin-meropenem combination for the treatment of severe infections caused by carbapenem-resistant, colistin-susceptible Gram-negative bacteria. We evaluated rectal swabs taken on Day 7 or later for the presence of new colistin-resistant (ColR) isolates. We evaluated the emergence of any ColR isolate and the emergence of ColR Enterobacteriaceae (ColR-E). Results Data were available for 214 patients for the primary analysis; emergent ColR organisms were detected in 22 (10.3%). No difference was observed between patients randomized to treatment with colistin monotherapy (10/106, 9.4%) versus patients randomized to colistin-meropenem combination therapy (12/108, 11.1%; P = .669). ColR-E organisms were detected in 18/249 (7.2%) patients available for analysis. No difference was observed between the 2 treatment arms (colistin monotherapy 6/128 [4.7%] vs combination therapy 12/121 [9.9%]; P = .111). Enterobacteriaceae, as the index isolate, was found to be associated with development of ColR-E (hazard ratio, 3.875; 95% confidence interval, 1.475–10.184; P = .006). Conclusions Carbapenem-colistin combination therapy did not reduce the incidence of colistin resistance emergence in patients with infections due to carbapenem-resistant organisms. Further studies are necessary to elucidate the development of colistin resistance and methods for its prevention.

Impact of Azithromycin-Based Extended-Spectrum Antibiotic Prophylaxis on Noninfectious Cesarean Wound Complications

2019 ◽  
Vol 36 (09) ◽  
pp. 886-890 ◽  
Author(s):  
Elizabeth B. Ausbeck ◽  
Victoria C. Jauk ◽  
Kim A. Boggess ◽  
George R. Saade ◽  
Sherri Longo ◽  
...  
Keyword(s):  
Antibiotic Prophylaxis ◽  
Cesarean Delivery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Wound Complications ◽  
Randomized Controlled ◽  
Extended Spectrum ◽  
Wound Breakdown ◽  
Singleton Pregnancies

Objective Adding azithromycin to standard antibiotic prophylaxis for unscheduled cesarean delivery has been shown to reduce postcesarean infections. Because wound infection with ureaplasmas may not be overtly purulent, we assessed the hypothesis that azithromycin-based extended-spectrum antibiotic prophylaxis also reduces wound complications that are identified as noninfectious. Study Design This is a secondary analysis of the C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) randomized controlled trial, which enrolled women with singleton pregnancies ≥24 weeks who were undergoing nonelective cesarean. Women were randomized to adjunctive azithromycin or identical placebo up to 1 hour preincision. All wound complications occurring within 6 weeks were adjudicated into infection and noninfectious wound complications (seroma, hematoma, local cellulitis, and other noninfectious wound breakdown). The primary outcome for this analysis is the composite of noninfectious wound complications. Results At a total of 14 sites, 2,013 women were randomized to adjunctive azithromycin (n = 1,019) or placebo (n = 994). Groups were similar at baseline. Although there was a lower rate of noninfectious wound complications in the azithromycin group compared with placebo (2.9 vs. 3.8%), this was not statistically significant (p = 0.22). Conclusion While adding azithromycin to usual antibiotic prophylaxis for nonelective cesarean delivery does reduce the risk of postcesarean infections, it did not significantly reduce the risk of postcesarean noninfectious wound complications.

scholarly journals Intravenous colistin combination is superior to monotherapy against carbapenem-resistant gram-negative bacterial infections: evidence from seven randomized controlled trials

2019 ◽  
Author(s):  
Zhong-dong Li ◽  
Genzhu Wang ◽  
Zhikun Xun ◽  
Xiaoying Wang ◽  
Qiang Sun ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Bacterial Infections ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Combination Regimen ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Carbapenem Resistant

Abstract Background Previous meta-analysis based on five randomized controlled trials (RCTs) did not display that intravenous colistin-based combination therapy is more efficacious than monotherapy against carbapenem resistant gram- negative bacterial infections. This meta-analysis aimed to further elucidate the efficacy.Methods PubMed, Embase, and Cochrane databases were searched up to March 2019 and only RCTs evaluating the combination therapy versus monotherapy against carbapenem or even colistin-resistant gram-negative bacteria infections were included. RevMan 5.3 was used to perform meta-analysis.Results Seven RCTs involving 859 patients were included. Total analysis showed that the combination therapy had a trend towards higher microbial response (RR, 1.21; 95% CI, 0.98 –1.51), lower infection-related mortality (RR, 0.75; 95% CI, 0.53–1.05), and significantly lower nephrotoxicity (RR, 0.77; 95% CI, 0.60 – 0.98) than monotherapy. Subgroup analysis on carbapenem-resistant A. baumannii infections displayed that the combination therapy had significantly higher microbiological response (RR, 1.39; P <0.001; 95% CI, 1.19–1.61). Another subgroup analysis on combination regimen for colistin plus rifampicin showed that the combination therapy had significantly higher eradication rate to carbapenem -resistant A. baumannii (RR, 1.35; 95% CI, 1.08–1.68). However, total and subgroup analysis showed no significant difference in all-cause mortality.Conclusions The present study suggests that intravenous colistin-based combination regimen, especially colistin plus rifampicin, may be superior to colistin alone against gram-negative bacterial infections, especially A. baumannii infection

Placental Pathological Findings following Adjusting Enoxaparin Dosage in Thrombophilic Women: Secondary Analysis of a Randomized Controlled Trial

2018 ◽  
Vol 119 (01) ◽  
pp. 087-091 ◽  
Author(s):  
Gali Garmi ◽  
Noah Zafran ◽  
Marina Okopnik ◽  
Israel Gavish ◽  
Shabtai Romano ◽  
...  
Keyword(s):  
Dose Group ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Factor Xa ◽  
Vascular Lesions ◽  
Fixed Dose ◽  
Randomized Controlled ◽  
Effect Of Treatment ◽  
Adjusted Dose

Objective Randomized trials showed no improvement in pregnancy outcomes with the use of low molecular weight heparin (LMWH) to prevent placenta-mediated pregnancy complications (PMPCs) among thrombophilic women. However, the effect of treatment on placental findings was not examined. We aimed to examine the occurrence of placental vascular lesions in thrombophilic women treated with LMWH dose adjusted according to anti-factor Xa compared with a fixed dose. Study Design This study was a secondary analysis of a randomized trial designed to examine whether LMWH dose adjusted according to anti-factor Xa levels compared with a fixed dose would reduce the risk of PMPC. Eligible women were randomly allocated in a 1:1 ratio to either a fixed dose of 40 mg daily LMWH (fixed dose group) or adjusted dose according to anti-factor Xa levels (adjusted dose group). Placentas were examined by the same perinatal pathologist who was blinded to group allocation. The primary outcome for this analysis was the incidence of maternal placental vascular lesions. Results During the study period, 88 placentas were examined; 41 and 47 from the fixed and adjusted dose groups, respectively. Demographics, obstetrics and types of thrombophilias were similar between the groups. Maternal placental vascular lesions were observed in 23 (56.1%) and 21 (44.68%) placentas (p = 0.28) and foetal placental vascular lesions in 2 (4.88%) and 1 (2.13%) placentas (p = 0.59) in the fixed and adjusted groups, respectively. Conclusion Adjusted dose of enoxaparin according to anti-factor Xa levels compared with a fixed dose did not affect placental vascular lesions in thrombophilic women.

scholarly journals Randomized controlled trial comparing the effectiveness of mass and spaced learning in microsurgical procedures using computer aided assessment

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wendy Z. W. Teo ◽  
Xiaoke Dong ◽  
Siti Khadijah Bte Mohd Yusoff ◽  
Soumen Das De ◽  
Alphonsus K. S. Chong
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Participant Satisfaction ◽  
Learning Group ◽  
Technical Performance ◽  
Randomized Controlled ◽  
Spaced Learning ◽  
Suturing Skills ◽  
Suture Placement ◽  
Better Than

AbstractSpaced-learning refers to teaching spread over time, compared to mass-learning where the same duration of teaching is completed in one session. Our hypothesis is that spaced-learning is better than mass-learning in retaining microsurgical suturing skills. Medical students were randomized into mass-learning (single 8-h session) and spaced-learning (2-h weekly sessions over 4 weeks) groups. They were taught to place 9 sutures in a 4 mm-wide elastic strip. The primary outcome was precision of suture placement during a test conducted 1 month after completion of sessions. Secondary outcomes were time taken, cumulative performance, and participant satisfaction. 42 students (24 in the mass-learning group; 18 in spaced-learning group) participated. 3 students in the spaced-learning group were later excluded as they did not complete all sessions. Both groups had comparable baseline suturing skills but at 1 month after completion of teaching, the total score for suture placement were higher in spaced-learning group (27.63 vs 31.60,p = 0.04). There was no statistical difference for duration and satisfaction in either group. Both groups showed an improvement in technical performance over the sessions, but this did not differ between both groups. Microsurgical courses are often conducted in mass-learning format so spaced learning offers an alternative that enhances retention of complex surgical skills.

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