A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella pneumoniae Carriage

2012 ◽  
Vol 33 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Lisa Saidel-Odes ◽  
Hana Polachek ◽  
Nehama Peled ◽  
Klaris Riesenberg ◽  
Francisc Schlaeffer ◽  
...  
Keyword(s):  
Klebsiella Pneumoniae ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Selective Digestive Decontamination ◽  
Control Measures ◽  
University Hospital ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Carbapenem Resistant ◽  
Polymyxin E

Objective.To assess the effectiveness of selective digestive decontamination (SDD) for eradicating carbapenem-resistant Klebsiella pneumoniae (CRKP) oropharyngeal and gastrointestinal carriage.Design.A randomized, double-blind, placebo-controlled trial with 7 weeks of follow-up per patient.Setting.A 1,000-bed tertiary-care university hospital.Patients.Adults with CRKP-positive rectal swab cultures.Methods.Patients were blindly randomized (1:1) over a 20-month period. The SDD arm received oral gentamicin and polymyxin E gel (0.5 g 4 times per day) and oral solutions of gentamicin (80 mg 4 times per day) and polymyxin E (1 × 106 units 4 times per day for 7 days). The placebo arm received oral placebo gel 4 times per day and 2 placebo oral solutions 4 times per day for 7 days. Strict contact precautions were applied. Samples obtained from the throat, groin, and urine were also cultured.Results.Forty patients (mean age ± standard deviation, 71 ± 16 years; 65% male) were included. At screening, greater than or equal to 30% of oropharyngeal, greater than or equal to 60% of skin, and greater than or equal to 35% of urine cultures yielded CRKP isolates. All throat cultures became negative in the SDD arm after 3 days (P< .0001). The percentages of rectal cultures that were positive for CRKP were significandy reduced at 2 weeks. At that time, 16.1% of rectal cultures in the placebo arm and 61.1% in the SDD arm were negative (odds ratio, 0.13; 95% confidence interval, 0.02–0.74; P<.0016). A difference between the percentages in the 2 arms was still maintained at 6 weeks (33.3% vs 58.5%). Groin colonization prevalence did not change in either arm, and the prevalence of urine colonization increased in the placebo arm.Conclusions.This SDD regimen could be a suitable decolonization therapy for selected patients colonized with CRKP, such as transplant recipients or immunocompromised patients pending chemotherapy and patients who require major intestinal or oropharyngeal surgery. Moreover, in outbreaks caused by CRKP infections that are uncontrolled by routine infection control measures, SDD could provide additional infection containment.Infect Control Hosp Epidemiol 2012;33(1):14-19

scholarly journals l-Serine and EPA Relieve Chronic Low-Back and Knee Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 150 (9) ◽  
pp. 2278-2286
Author(s):  
Ikuko Sasahara ◽  
Akiko Yamamoto ◽  
Masamichi Takeshita ◽  
Yasuyo Suga ◽  
Katsuya Suzuki ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Pain ◽  
Medical Information ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
University Hospital ◽  
Active Group ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo

ABSTRACT Background Multisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life. Objectives This study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates. Results The JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P &lt; 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11–27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed. Conclusions l-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.

scholarly journals Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017652 ◽  
Author(s):  
Christelle Nguyen ◽  
Isabelle Boutron ◽  
Gabriel Baron ◽  
Emmanuel Coudeyre ◽  
Francis Berenbaum ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
The Mean ◽  
Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

Outbreak of Carbapenem-Resistant Klebsiella pneumoniae in Puerto Rico Associated with a Novel Carbapenemase Variant

2010 ◽  
Vol 31 (05) ◽  
pp. 476-484 ◽  
Author(s):  
Christopher J. Gregory ◽  
Eloisa Llata ◽  
Nicholas Stine ◽  
Carolyn Gould ◽  
Luis Manuel Santiago ◽  
...  
Keyword(s):  
Risk Factors ◽  
Puerto Rico ◽  
Klebsiella Pneumoniae ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Multivariable Analysis ◽  
Control Measures ◽  
Control Group ◽  
Surveillance Culture ◽  
Carbapenem Resistant

Background.Carbapenem-resistantKlebsiella pneumoniae(CRKP) is resistant to almost all antimicrobial agents, and CRKP infections are associated with substantial morbidity and mortality.Objective.To describe an outbreak of CRKP in Puerto Rico, determine risk factors for CRKP acquisition, and detail the successful measures taken to control the outbreak.Design.Two case-control studies.Setting.A 328-bed tertiary care teaching hospital.Patients.Twenty-six CRKP case patients identified during the outbreak period of February through September 2008, 26 randomly selected uninfected control patients, and 26 randomly selected control patients with carbapenem-susceptibleK. pneumoniae(CSKP) hospitalized during the same period.Methods.We performed active case finding, including retrospective review of the hospital's microbiology database and prospective perirectal surveillance culture sampling in high-risk units. Case patients were compared with each control group while controlling for time at risk. We sequenced theblaKPCgene with polymerase chain reaction for 7 outbreak isolates and subtyped these isolates with pulsed-field gel electrophoresis.Results.In matched, multivariable analysis, the presence of wounds (hazard ratio, 19.0 [95% confidence interval {CI}, 2.5-142.0]) was associated with CRKP compared with noK. pneumoniae.Transfer between units (adjusted odds ratio [OR], 7.5 [95% CI, 1.8-31.1]), surgery (adjusted OR, 4.0 [95% CI, 1.0-15.7]), and wounds (adjusted OR, 4.9 [95% CI, 1.1-21.8]) were independent risk factors for CRKP compared to CSKP. A novelK. pneumoniaecarbapenemase variant (KPC-8) was present in 5 isolates. Implementation of active surveillance for CRKP colonization and cohorting of CRKP patients rapidly controlled the outbreak.Conclusions.Enhanced surveillance for CRKP colonization and intensified infection control measures that include limiting the physical distribution of patients can reduce CRKP transmission during an outbreak.

Aerosolized Beta2-Agonists Do Not Induce Bronchial Hyperreactivity in Healthy Adults

1995 ◽  
Vol 29 (9) ◽  
pp. 848-851
Author(s):  
H William Kelly ◽  
Bennie C McWilliams ◽  
Shirley Murphy
Keyword(s):  
Clinical Trial ◽  
Treatment Period ◽  
Tertiary Care ◽  
Bronchial Hyperreactivity ◽  
University Hospital ◽  
Bronchial Smooth Muscle ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Clinical Research Center ◽  
General Clinical Research Center

Objective: To determine whether regular administration of beta2 agonists could induce bronchial hyperreactivity in nonasthmatic volunteers. Design: A prospective, randomized, double-blind, placebo-controlled, crossover clinical trial of 2 weeks therapy with a 2-week washout period between each treatment period. Treatments were albuterol or matching placebo as 2 inhalations 4 times daily. Subjects: Ten healthy, nonsmoking women 27—37 years old. Setting: General clinical research center of a tertiary care university hospital. Main Outcome Measures: Baseline spirometry and methacholine bronchoprovocation studies were performed immediately prior to, 12 hours following, and 1 and 2 weeks following each treatment period. Results: No change was detected in either baseline spirometry or methacholine responsiveness. Conclusions: This suggests that if beta2-agonists induce a rebound bronchial hyperreactivity, it is not the result of the production of tolerance or a direct effect on bronchial smooth muscle.

Institutional Control Measures to Curtail the Epidemic Spread of Carbapenem-Resistant Klebsiella pneumoniae: A 4-Year Perspective

2011 ◽  
Vol 32 (7) ◽  
pp. 673-678 ◽  
Author(s):  
Matan J. Cohen ◽  
Colin Block ◽  
Phillip D. Levin ◽  
Carmela Schwartz ◽  
Ilana Gross ◽  
...  
Keyword(s):  
Klebsiella Pneumoniae ◽  
Active Surveillance ◽  
Tertiary Care ◽  
Control Measures ◽  
Change Point Analysis ◽  
Carrier Status ◽  
Epidemic Spread ◽  
Carbapenem Resistant ◽  
Tertiary Care Medical Center ◽  
The Mean

Objective.To describe the implementation of an institution-wide, multiple-step intervention to curtail the epidemic spread of carbapenem-resistant Klebsiella pneumoniae (CRKP).Design.Consecutive intervention analyses.Patients and Setting.All patients admitted to a 775-bed tertiary care medical center in Jerusalem, Israel, from 2006 through 2010.Interventions.The effects of 4 interventions were assessed: (1) a policy of isolation for patients colonized or infected with CRKP in single rooms, which was started in March 2006; (2) cohorting of CRKP patients with dedicated nursing staff and screening of patients neighboring a patient newly identified as a carrier of CRKP, which was started in March 2007; (3) weekly active surveillance of intensive care unit patients, which was started during August 2008; and (4) selective surveillance of patients admitted to the emergency department, which was started in March 2009. Interrupted regression analysis and change-point analysis were used to assess the effect of each intervention on the CRKP epidemic.Results.Patient isolation alone failed to control the spread of CRKP, with incidence increasing to a peak of 30 new cases per 1,000 hospital beds per month. Institution of patient cohorting led to a steep decline in the incidence of CRKP acquisition (P< .001). Introduction of active surveillance interventions was followed by a decrease in the incidence of CRKP-positive clinical cultures but an increase in the incidence of CRKP-positive screening cultures. The mean prevalence of CRKP positivity for the period after cohorting began showed a statistically significant change from the mean prevalence in the preceding period (P< .001).Conclusions.The cohorting of patients with dedicated staff, combined with implementation of focused active surveillance, effectively terminated the epidemic spread of CRKP. Cohorting reduced cross-infection within the hospital, and active surveillance allowed for earlier detection of carrier status. Both interventions should be considered in attempts to contain a hospital epidemic.

scholarly journals 235. Next-Generation Sequencing for Investigation of Hospital Outbreak of Carbapenem--Resistant Klebsiella pneumoniae

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S134-S134
Author(s):  
Amani Kholy ◽  
May Mohamed Sherif Soliman ◽  
Arwa Ramadan ◽  
Jehan El-Kholy
Keyword(s):  
Klebsiella Pneumoniae ◽  
Tertiary Care ◽  
Public Health Problem ◽  
Illumina Miseq ◽  
University Hospital ◽  
Resistance Pattern ◽  
Care Hospital ◽  
Hospital Outbreak ◽  
Carbapenem Resistant ◽  
Carbapenem Resistant Enterobacteriaceae

Abstract Background Carbapenem--resistant Enterobacteriaceae constitute an urgent public health problem worldwide. In 2018, carbapenem--resistant Klebsiella pneumoniae (CR-KP) caused outbreaks of infection in 4 intensive-care units (ICUs)in a tertiary-care hospital in Egypt. We aimed to identify the clonal relatedness of isolates by whole genome (WGS). Methods Identification and antibiotic susceptibility testing was done by VITEK-2. Eleven isolates showed identical resistance pattern (resistant to Amikacin, gentamicin, Imipenem, meropenem, levofloxacin, and Piperacillin/Tazobactam) and were susceptible only to colistin. Caba-NP test was positive for carbapenemase production. The 11 isolates were studied by WGS by Illumina Miseq in a reference lab in Cairo University Hospital. Results In only one ICU, WGS identified 4 outbreak isolates of CR-KP that group together as a tight clonal cluster, suggestive of intra-ward transmission event. The outbreak isolates belonged to MLST 147. All isolates carried blaCTXM-15, blaoxa-48, and blaNDM1 encoding ESBL and carbapenemase activity. Other identified resistance genes were Str, AadA, MsrE, Tet, and DfrA, encoding resistance to aminoglycosides, macrolide–lincosamide–streptogramin, tetracycline and trimethoprim/sulphonamides. Virulence genes included Yersiniabactin, aerobactin, rmpA, rmpA2 and wzi64, which has been associated with pathogenicity and hypervirulent K. pneumoniae lineages. No clonal relationships were identified between the isolates from other ICUs. Conclusion WGS is a powerful tool that goes beyond high-resolution tracking of transmission events into identifying the genetic basis of drug-resistance and virulence. Disclosures All authors: No reported disclosures.

scholarly journals Epidemiology and infection control of carbapenem resistant Acinetobacter baumannii and Klebsiella pneumoniae at a German university hospital: a retrospective study of 5 years (2015–2019)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Patrick Chhatwal ◽  
Ella Ebadi ◽  
Frank Schwab ◽  
Stefan Ziesing ◽  
Ralf-Peter Vonberg ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Klebsiella Pneumoniae ◽  
Infection Control ◽  
Hospital Stay ◽  
Acinetobacter Baumannii ◽  
Control Measures ◽  
University Hospital ◽  
Resistant Bacteria ◽  
Carbapenem Resistant ◽  
History Of

Abstract Background Carbapenem resistant (CR) Klebsiella pneumoniae (Kp) and Acinetobacter baumannii (Ab) are emerging multidrug resistant bacteria with very limited treatment options in case of infection. Both are well-known causes of nosocomial infections and outbreaks in healthcare facilities. Methods A retrospective study was conducted to investigate the epidemiology of inpatients with CR Kp and CR Ab in a 1500-bed German university hospital from 2015 to 2019. We present our infection control concept including a weekly microbiologic screening for patients who shared the ward with a CR Kp or CR Ab index patient. Results Within 5 years, 141 CR Kp and 60 CR Ab cases were hospitalized corresponding to 118 unique patients (74 patients with CR Kp, 39 patients with CR Ab and 5 patients with both CR Ab and CR Kp). The mean incidence was 0.045 (CR Kp) and 0.019 (CR Ab) per 100 inpatient cases, respectively. Nosocomial acquisition occurred in 53 cases (37.6%) of the CR Kp group and in 12 cases (20.0%) of the CR Ab group. Clinical infection occurred in 24 cases (17.0%) of the CR Kp group and in 21 cases (35.0%) of the CR Ab group. 14 cases (9.9%) of the CR Kp group and 29 cases (48.3%) of the CR Ab group had a history of a hospital stay abroad within 12 months prior to admission to our hospital. The weekly microbiologic screening revealed 4 CR Kp cases caused by nosocomial transmission that would have been missed without repetitive screening. Conclusions CR Kp and CR Ab cases occurred infrequently. A history of a hospital stay abroad, particularly in the CR Ab group, warrants pre-emptive infection control measures. The weekly microbiologic screening needs further evaluation in terms of its efficiency.

Placebo-Controlled Trial of Naftazone in Women with Primary Uncomplicated Symptomatic Varicose Veins

1997 ◽  
Vol 12 (1) ◽  
pp. 17-20 ◽  
Author(s):  
M. Vayssairat ◽  
Keyword(s):  
Analogue Scale ◽  
Time Course ◽  
Varicose Veins ◽  
Controlled Trial ◽  
Group Versus ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Dosage Regimens

Objective: To evaluate the effectiveness and best time course of prescription of 30 mg/day oral naftazone (N) in women with primary uncomplicated symptomatic varicose veins (PUSVV). Design: Double-blind, placebo (P)-controlled study. Setting: Multicentre study, coordinated by a University hospital in Paris, France. Patients: 270 women with PUSVV. Interventions: Treatment with naftazone (three dosage regimens) or placebo for 14 days. Main outcome measures: Comparison by ANOVA, at day 0 and after 14 days of treatment, of (1) clinical disability, using an analogue scale 100 mm long and (2) morning and evening leg volumes. Results: The reduction in disability at day 14 was 32 ± 23 mm in the N group versus 24 ± 20 in the P group, F = 6.35, p = 0.01. Best clinical efficacy was obtained in the subgroup given 30 mg N once a day at midday (35 ± 22 mm). Differences between morning leg volumes on days 0 and 14 were 19.3 ± 74 ml in the N group versus 5.5 ± 50 in the P group, p = 0.059. Conclusion: Naftazone was more effective than placebo for the clinical improvement of women with PUSVV.

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