scholarly journals Nebulised colistin for ventilator-associated pneumonia prevention

2015 ◽  
Vol 46 (6) ◽  
pp. 1732-1739 ◽  
Author(s):  
Marios Karvouniaris ◽  
Demosthenes Makris ◽  
Paris Zygoulis ◽  
Apostolos Triantaris ◽  
Stelios Xitsas ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Multidrug Resistant ◽  
University Hospital ◽  
Incidence Density ◽  
Ventilator Associated Pneumonia ◽  
Open Label ◽  
The University ◽  
Incidence Density Rate ◽  
Density Rate

We evaluated whether prophylactic nebulised colistin could reduce ventilator-associated pneumonia (VAP) rates in an intensive care unit (ICU) setting with prevalent multidrug-resistant (MDR) bacteria.We used a single-centre, two-arm, randomised, open-label, controlled trial in a 12-bed ICU in the University Hospital of Larissa, Greece. Patient inclusion criteria included mechanical ventilation of >48 h. The two arms consisted of prophylaxis with 500 000 U colistin (Col group) or normal saline (NS group), thrice daily, for the first 10 ICU days or until extubation. The primary outcome of the study was the 30-day VAP incidence.In total, 168 patients entered the study. VAP incidence was not different between Col and NS group patients (14 (16.7%)versus25 (29.8%), respectively, p=0.07). Regarding the secondary outcomes, the intervention resulted in a lower VAP incidence density rate (11.4versus25.6, respectively, p<0.01), and less Gram-negative bacteria-VAP (p=0.03) and MDR-VAP (p=0.04). Among VAP patients (n=39), prophylaxis with inhaled colistin improved ICU survival (p=0.016). There was no evidence of increased resistance to colistin or multidrug resistance.Our findings suggest that nebulised colistin had no significant effect on VAP incidence.

scholarly journals Enteroadsorbent Polymethylsiloxane Polyhydrate vs. Probiotic Lactobacillus reuteri DSM 17938 in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers, a Randomized Controlled Trial

2020 ◽  
Vol 8 ◽  
Author(s):  
Leo Markovinović ◽  
Ivica Knezović ◽  
Tihana Kniewald ◽  
Lorna Stemberger Marić ◽  
Vladimir Trkulja ◽  
...  
Keyword(s):  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
University Hospital ◽  
Bowel Habit ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Recommended Treatment ◽  
Significant Difference ◽  
The University

Purpose: The aim of this study was to compare two adjunct therapies in the treatment of childhood rotavirus gastroenteritis (RVGE). We compared the recommended treatment, probiotic Lactobacillus reuteri DSM 17938 (BioGaia®), vs. a novel treatment, enterosorbent polymethylsiloxane polyhydrate (Enterosgel®).Methods: This was an open-label, randomized, clinical controlled trial at the University Hospital for Infectious Diseases (UHID) in Zagreb, Croatia. A total of 149 children aged 6–36 months with acute rotaviral gastroenteritis over a period of &lt;48 h, with no significant chronic comorbidity, were randomized to receive the standard therapy with L. reuteri DSM 17938 (hereafter L. reuteri) or polymethylsiloxane polyhydrate (hereafter PMSPH) therapy, during 5 days. The primary end point was time to recovery in days in both groups. The recovery was defined as absence of fever and vomiting and either the first firm stool, absence of stool for more than 24 h, or return of usual bowel habit.Results: A total of 75 children were randomized into the L. reuteri group and 74 were randomized into the PMSPH group; after excluding missing data, the data from 65 children in each group were analyzed. There was no significant difference in the treatment efficacy between the two regimens with an estimated median time of recovery of 6 days in both groups (p = 0.754). No significant side effects were observed in either group.Conclusion: Novel enterosorbent PMSPH had a similar efficacy to probiotic L. reuteri in the treatment of rotaviral gastroenteritis in preschool children.Clinical Trial Registration:ClinicalTrials.gov Identifier: NCT04116307 [October 3, 2019] (retrospectively registered). https://clinicaltrials.gov/show/NCT04116307.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Welén ◽  
Anna K Överby ◽  
Clas Ahlm ◽  
Eva Freyhult ◽  
David Robinsson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Virus Disease ◽  
Controlled Trial ◽  
Scale Up ◽  
Standard Of Care ◽  
University Hospital ◽  
Ordinal Scale ◽  
Open Label ◽  
Full Protocol ◽  
Exploration Phase

Abstract Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Investigation ofAnaplasma marginaleSeroprevalence in a Traditionally Managed Large California Beef Herd

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Thomas R. Tucker ◽  
Sharif S. Aly ◽  
John Maas ◽  
Josh S. Davy ◽  
Janet E. Foley
Keyword(s):  
Anaplasma Marginale ◽  
Incidence Density ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Cattle Disease ◽  
Angus Cattle ◽  
Increased Risk ◽  
Test Kit ◽  
Incidence Density Rate ◽  
Density Rate

Recent observations by stakeholders suggested that ecosystem changes may be driving an increased incidence of bovine erythrocytic anaplasmosis, resulting in a reemerging cattle disease in California. The objective of this prospective cohort study was to estimate the incidence ofAnaplasma marginaleinfection using seroconversion in a northern California beef cattle herd. A total of 143 Black Angus cattle (106 prebreeding heifers and 37 cows) were enrolled in the study. Serum samples were collected to determineAnaplasma marginaleseroprevalence using a commercially available competitive enzyme-linked immunosorbent assay test kit. Repeat sampling was performed in seronegative animals to determine the incidence density rate from March through September (2013). Seroprevalence of heifers was significantly lower than that of cows at the beginning of the study (P<0.001) but not at study completion (P=0.075). Incidence density rate ofAnaplasma marginaleinfection was 8.17 (95% confidence interval: 6.04, 10.81) cases per 1000 cow-days during the study period. Study cattle becameAnaplasma marginaleseropositive and likely carriers protected from severe clinical disease that might have occurred had they been first infected as mature adults. No evidence was found within this herd to suggest increased risk for clinical bovine erythrocytic anaplasmosis.

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

scholarly journals Incidence Density Rate of Neonatal Mortality and Predictors in Sub-Saharan Africa: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Zebenay Workneh Bitew ◽  
Ayinalem Alemu ◽  
Ermias Getaneh Ayele ◽  
Desalegn Abebaw Jember ◽  
Michael Tamene Haile ◽  
...  
Keyword(s):  
Intensive Care ◽  
Neonatal Mortality ◽  
Intensive Care Units ◽  
Neonatal Intensive Care ◽  
Sub Saharan Africa ◽  
Incidence Density ◽  
Neonatal Intensive Care Units ◽  
Sub Saharan ◽  
Incidence Density Rate ◽  
Density Rate

Background. Neonatal mortality in Sub-Saharan countries is remarkably high. Though there are inconsistent studies about the incidence density rate of neonatal mortalities (IDR) and predictors in Sub-Saharan Africa, they are inconclusive to policymakers and program planners. In this study, the IDR of neonatal mortalities and predictors was determined. Methods. Electronic databases (Web of Science, PubMed, EMBASE (Elsevier), Scopus, CINAHL (EBSCOhost), World Cat, Google Scholar, and Google) were explored. 20 out of 818 studies were included in this study. The IDRs and predictors of neonatal mortality were computed from studies conducted in survival analysis. Fixed and random effect models were used to compute pooled estimates. Subgroup and sensitivity analyses were performed. Results. Neonates were followed for a total of 1,095,611 neonate-days; 67142 neonate-days for neonates treated in neonatal intensive care units and 1,028,469 neonate-days for community-based studies. The IDRs of neonatal mortalities in neonatal intensive care units and in the community were 24.53 and 1.21 per 1000 person-days, respectively. The IDRs of early and late neonatal mortalities neonatal intensive care units were 22.51 and 5.09 per 1000 neonate-days, respectively. Likewise, the IDRs of early and late neonatal mortalities in the community were 0.85 and 0.31, respectively. Not initiating breastfeeding within one hour, multiple births, rural residence, maternal illness, low Apgar score, being preterm, sepsis, asphyxia, and respiratory distress syndrome were independent predictors of time to neonatal mortality in neonatal intensive care units and male gender, perceived small size, multiple births, and ANC were predictors of neonatal mortality in the community. Conclusion. The incidence density rate of neonatal mortality in Sub-Saharan Africa is significantly high. Multiple factors (neonatal and maternal) were found to be independent predictors. Strategies must be designed to address these predictors, and prospective studies could reveal other possible factors of neonatal mortalities.

Effectiveness and Safety of an Inactivated Enterovirus 71 Vaccine in Children Aged 6–71 Months in a Phase IV Study

2019 ◽  
Vol 71 (9) ◽  
pp. 2421-2427 ◽  
Author(s):  
Xuhua Guan ◽  
Yanchun Che ◽  
Sheng Wei ◽  
Shaoping Li ◽  
Zhimei Zhao ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Large Population ◽  
Enterovirus 71 ◽  
Group Versus ◽  
Vaccine Group ◽  
Incidence Density ◽  
Control Group ◽  
Passive Surveillance ◽  
Open Label ◽  
Phase Iv

Abstract Background Evaluation of a licensed inactivated enterovirus type 71 (EV71) vaccine is needed in a phase IV study with a large population to identify its effectiveness and safety for further application. Methods An open-label, controlled trial involving a large population of 155 995 children aged 6–71 months was performed; 40 724 were enrolled in the vaccine group and received 2 doses of inactivated EV71 vaccine at an interval of 1 month, and the remaining children were used as the control group. The EV71-infected cases with hand, foot, and mouth disease were monitored in the vaccine and control groups during a follow-up period of 14 months since the 28th day postinoculation through the local database of the Notifiable Infectious Diseases Network. The effectiveness of the vaccine was estimated by comparing the incidence density in the vaccine group versus that in the control group based upon EV71-infected patients identified via laboratory testing. In parallel, the active and passive surveillance for safety of the vaccine was conducted by home or telephone visits and by using the Adverse Event Following Immunization (AEFI) system, respectively. Results An overall level of 89.7% (95% confidence interval, 24.0–98.6%) vaccine effectiveness against EV71 infection and a 4.58% rate of reported adverse events were observed. Passive surveillance demonstrated a 0.31% rate of reported common minor reactions. Conclusions The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population. Clinical Trials Registration NCT03001986.

scholarly journals Controlled Trial of a 5-Day Course of Telithromycin versus Doxycycline for Treatment of Mild to Moderate Scrub Typhus

2007 ◽  
Vol 51 (6) ◽  
pp. 2011-2015 ◽  
Author(s):  
Dong-Min Kim ◽  
Ki Dong Yu ◽  
Ji Hyun Lee ◽  
Hyun Kuk Kim ◽  
Seung-Hyun Lee
Keyword(s):  
Adverse Events ◽  
Scrub Typhus ◽  
Controlled Trial ◽  
Sensitivity Study ◽  
University Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Antibiotics

ABSTRACT New antibiotics are required to have the antibacterial activity against doxycycline-resistant Orientia tsutsugamushi. An in vitro sensitivity study showed that telithromycin was more effective than erythromycin for Rickettsia, Bartonella, and Coxiella burnetii. In this prospective, open-label, randomized trial, we enrolled patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day telithromycin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital or one of its two community-based affiliated hospitals (Jangheung Hospital and Cheomdan Hospital), which are all located in southwestern Korea, between September and December 2005. A total of 92 patients were randomly assigned to either the telithromycin group (n = 47) or the doxycycline group (n = 45). After the treatment, fever control time was 20.45 ± 12.9 h in the telithromycin group and 22.60 ± 21.44 h in the doxycycline group (P > 0.05). After the treatment, the cure rate was 100% in the telithromycin group and 97.8% in the doxycycline group (P > 0.05). Furthermore, there were no significant differences in time elapsed until such symptoms as headache, myalgia, and rash disappeared. No serious adverse events or death were noted following the treatment in both groups. There were no significant differences in adverse events. In conclusion, the efficacy and safety of a 5-day once-a-day regimen of 800 mg telithromycin were equivalent to those of a 5-day twice-a-day regimen of 100 mg doxycycline in patients with mild-to-moderate scrub typhus. Telithromycin could be considered a promising new antibacterial agent for patients with scrub typhus.

scholarly journals Convalescent plasma for hospitalized patients with COVID-19 and the effect of plasma antibodies: a randomized controlled, open-label trial

2021 ◽  
Author(s):  
Philippe Bégin ◽  
Jeannie Callum ◽  
Erin Jamulae Jamula ◽  
Richard Cook ◽  
Nancy M Heddle ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Harmful Effect ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Negative Results ◽  
Intent To Treat

The efficacy of convalescent plasma for COVID-19 is unclear. While most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content may influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients were allocated 2:1 to 500 mL of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 days. The effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. 940 patients were randomized and 921 patients were included in the intent-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) in the convalescent plasma arm and 86/307 (28.0%) in the standard of care arm; relative risk (RR) 1.16 (95% confidence interval (CI) 0.94-1.43; p=0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% vs. 26.4%; RR=1.27, 95% CI 1.02-1.57, p=0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standard log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (OR=0.74; 0.57-0.95 and OR=0.66; 0.50-0.87, respectively), while IgG against the full transmembrane Spike protein increased it (OR=1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 days among hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavourable antibody profiles may be associated with worse clinical outcomes compared to standard care.

scholarly journals Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial

2021 ◽  
Vol 9 (4) ◽  
pp. e001452
Author(s):  
Navindra Persaud ◽  
Kevin E Thorpe ◽  
Michael Bedard ◽  
Stephen W Hwang ◽  
Andrew Pinto ◽  
...  
Keyword(s):  
General Health ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Risk Difference ◽  
Cash Transfer ◽  
Random Allocation ◽  
Open Label ◽  
Clinical Criteria ◽  
Secondary Outcomes ◽  
Close Contacts

ObjectiveTo evaluate the effect of a one-time cash transfer of $C1000 in people who are unable to physically distance due to insufficient income.DesignOpen-label, multi-centre, randomised superiority trial.SettingSeven primary care sites in Ontario, Canada; six urban sites associated with St. Michael’s Hospital in Toronto and one in Manitoulin Island.Participants392 individuals who reported trouble affording basic necessities due to disruptions related to COVID-19.InterventionAfter random allocation, participants either received the cash transfer of $C1000 (n=196) or physical distancing guidelines alone (n=196).Main outcome measuresThe primary outcome was the maximum number of symptoms consistent with COVID-19 over 14 days. Secondary outcomes were meeting clinical criteria for COVID-19, SARS-CoV-2 presence, number of close contacts, general health and ability to afford basic necessities.ResultsThe primary outcome of number of symptoms reported by participants did not differ between groups after 2 weeks (cash transfer, mean 1.6 vs 1.9, ratio of means 0.83; 95% CI 0.56 to 1.24). There were no statistically significant effects on secondary outcomes of the meeting COVID-19 clinical criteria (7.9% vs 12.8%; risk difference −0.05; 95% CI −0.11 to 0.01), SARS-CoV-2 presence (0.5% vs 0.6%; risk difference 0.00 95% CI −0.02 to 0.02), mean number of close contacts (3.5 vs 3.7; rate ratio 1.10; 95% CI 0.83 to 1.46), general health very good or excellent (60% vs 63%; risk difference −0.03 95% CI −0.14 to 0.08) and ability to make ends meet (52% vs 51%; risk difference 0.01 95% CI −0.10 to 0.12).ConclusionsA single cash transfer did not reduce the COVID-19 symptoms or improve the ability to afford necessities. Further studies are needed to determine whether some groups may benefit from financial supports and to determine if a higher level of support is beneficial.Trial registration numberNCT04359264.

Sign in / Sign up

Export Citation Format

Share Document