scholarly journals Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty

2017 ◽  
Vol 6 (20;6) ◽  
pp. 521-528
Author(s):  
Douglas P. Beall
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Unplanned Readmission ◽  
Vertebral Augmentation ◽  
Readmission Rates ◽  
Serious Adverse Events ◽  
Multicenter Randomized Controlled Trial ◽  
One Year

Background: The KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implantbased approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another. Objectives: The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs. Study Design: The KAST trial is a pivotal, multicenter, randomized, controlled trial conducted to evaluate an implant-based vertebral augmentation approach (implant) against BK. Post-hoc analysis was performed to evaluate SAEs and readmission rates. Setting: Twenty-one sites in North America and Europe. Methods: The treatment effect of vertebral implant versus BK on SAEs requiring unplanned readmission was evaluated by estimating the risk of SAEs associated with readmissions in KAST while controlling for key baseline covariates using multivariate Poisson regression modeling. Results: Forty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis. Limitations: The power of the KIVA study was based on clinical efficacy criteria to meet FDA requirements and recommendations for equivalency or noninferiority. The primary endpoint in this posthoc analysis is SAEs associated with readmissions; as a result, the sample size is underpowered, although the results remain significant. Conclusion: The augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions.

Balloon Kyphoplasty Improves Both Roland-Morris Disability Scores and Bone Pain among Cancer Patients with Vertebral Compression Fractures: Interim Analysis of Results from a Phase IV Random Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3695-3695
Author(s):  
James R. Berenson ◽  
John B Tillman ◽  
Mohamad A. Hussein ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
...  
Keyword(s):  
Back Pain ◽  
Adverse Events ◽  
Cancer Patients ◽  
Interim Analysis ◽  
Balloon Kyphoplasty ◽  
The United States ◽  
Vertebral Compression Fractures ◽  
Serious Adverse Events ◽  
Compression Fractures ◽  
Patients With Cancer

Abstract Destructive vertebral lesions are a common source of morbidity among patients with cancer. Balloon kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life. We report the results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of this procedure. Twenty-one sites in Europe, the United States, Canada and Australia enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with a variety of cancers and ≤ 3 painful VCFs (VAS ≥ 4) were randomly assigned to immediate kyphoplasty (N=70) or nonsurgical supportive care (N=64). Patients with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site were excluded as well as patients with spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire, a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Back pain was also assessed using a validated 0- (no pain) to 10-point (worst pain imaginable) numerical rating scale. Data from a preplanned interim analysis of this ongoing study are now reported. For pain and function, patients with complete data that has been evaluated through one month are included whereas all enrolled patients were analyzed for safety. Mean patient age was 64 years (range 37 to 88), 58% were female, and tumor types included multiple myeloma (36%), cancers of the breast (20%), lung (8%), prostate (6%) and other sites (30%). At study enrollment, 23% of patients were on daily corticosteroids and 48% had received bisphosphonates within 12 months of study entry. Prior to randomization, single VCFs were identified by the local investigators in 43% of patients; an equal proportion (29%) of patients had 2 or 3 fractures. Among the kyphoplasty and nonsurgical cohorts, 59 and 56 subjects, respectively were evaluable for the efficacy analysis. At baseline, average Roland-Morris scores were similar between the groups; 17.7 and 18.3 points for kyphoplasty and non-surgical-treated patients, respectively. However, at one month, there were marked differences between the two groups with a mean improvement for patients randomized to kyphoplasty of −8.3 points (95% CI −6.2 to −10.5) whereas those receiving non-surgical care showed no significant change (−0.1 points, 95% CI 0.9 to −1.0; p<0.0001 for difference). Mean baseline pain scores were also not different between the two groups (7.2 and 7.3 points for the kyphoplasty and nonsurgical groups, respectively). At one week, kyphoplasty-treated patients showed significant improvement in their back pain (−3.6 points, 95%CI, −2.8 to −4.4) whereas those patients treated non-surgically had no change in their pain (−0.3 points, 95%CI, 0.1 to −0.8; p<0.0001 for difference). Similar results for pain were obtained at one month; kyphoplasty resulted in a −4.1 point change (95%CI, −3.2 to −4.9) and those patients treated non-surgically had no change in their pain (−0.5 points; 95%CI, 0.04 to −1.0; p<0.0001 for difference). There was no significant difference in the number of patients with serious adverse events between the kyphoplasty (16) and nonsurgical (10) groups at one month. None of the serious adverse events in the kyphoplasty group were related to the devices used, including bone cement extravasation; one serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. This randomized study shows, at a pre-planned interim analysis time point, that patients with cancer-related VCFs treated with immediate balloon kyphoplasty show a marked reduction in back disability and pain at one month compared to non-surgical treatment. Pain reduction was also statistically significantly improved within one week postoperatively. Importantly, minimally clinically important differences for the Roland-Morris and pain scales used in this trial have been determined from previous studies and are estimated to be approximately 2.5 and 2.0 points, respectively. Thus, these improvements in disability and pain with balloon kyphoplasty were both statistically and clinically significant and achieved without an increase in adverse events.

scholarly journals 1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S659-S659
Author(s):  
Angela Talley ◽  
Archie Thurston ◽  
Grayson Moore ◽  
Myriah M Satterfield ◽  
Erika L Manyak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Controlled Trial ◽  
Phase 1 ◽  
Safety Data ◽  
Elderly Subjects ◽  
Independent Contractor ◽  
Serious Adverse Events ◽  
Healthy Elderly ◽  
Dose Proportional

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)

scholarly journals Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for status epilepticus: study protocol for a multicenter non-inferiority designed randomized control trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kensuke Nakamura ◽  
◽  
Aiki Marushima ◽  
Yuji Takahashi ◽  
Akio Kimura ◽  
...  
Keyword(s):  
Status Epilepticus ◽  
Adverse Events ◽  
Controlled Trial ◽  
Insurance Coverage ◽  
Line Treatment ◽  
Second Line ◽  
Open Label ◽  
Consciousness Disturbance ◽  
Multicenter Randomized Controlled Trial ◽  
Severe Adverse Events

Abstract Background Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is important. Phenytoin and fosphenytoin, the prodrug of phenytoin with less severe adverse effects, have been recommended as second-line treatments. However, fosphenytoin causes severe adverse events, such as hypotension and arrhythmia. Levetiracetam reportedly has similar efficacy and higher safety for SE; however, evidence to support its use for adult SE is lacking. In the present study, a non-inferiority designed multicenter randomized controlled trial (RCT) is being conducted to compare levetiracetam with fosphenytoin after diazepam as a second-line treatment for SE. Methods This multicenter, prospective, and open-label RCT is conducted in emergency departments. Between December 23, 2019, and March 31, 2023, 176 patients with convulsive SE transported to an emergency room will be randomized into a fosphenytoin group and levetiracetam group at a ratio of 1:1. The definition of SE is “continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbance.” In both groups, diazepam is initially administered at 1–20 mg, followed by intravenous fosphenytoin at 22.5 mg/kg or intravenous levetiracetam at 1000–3000 mg. The primary outcome is the seizure cessation rate within 30 min. Seizure recurrence within 24 h, severe adverse events, and intubation rate within 24 h are secondary outcomes. Discussion The present study was approved and conducted as an initiative study of the Japanese Association for Acute Medicine. If non-inferiority is identified, the society will pursue an application for the national health insurance coverage of levetiracetam for SE via a public knowledge-based application. Trial registration Japan Registry of Clinical Trials jRCTs031190160. Registered on December 13, 2019

Allopurinol dose escalation to achieve serum urate below 6 mg/dL: an open-label extension study

2017 ◽  
Vol 76 (12) ◽  
pp. 2065-2070 ◽  
Author(s):  
Lisa K Stamp ◽  
Peter T Chapman ◽  
Murray Barclay ◽  
Anne Horne ◽  
Christopher Frampton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Escalation ◽  
Controlled Trial ◽  
Serum Urate ◽  
Extension Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Extension ◽  
Randomised Controlled ◽  
Kidney Impairment

ObjectivesTo determine the long-term safety and efficacy of allopurinol dose escalation (DE) to achieve target serum urate (SU) in gout.MethodsPeople, including those with chronic kidney disease, who completed the first 12 months of a randomised controlled trial continued into a 12-month extension study. Participants randomised to continue current dose for the first 12 months began allopurinol DE at month 12 if SU was ≥6 mg/dL (control/DE). Immediate DE participants who achieved target SU maintained allopurinol dose (DE/DE). The primary endpoints were reduction in SU and adverse events (AEs) at month 24.ResultsThe mean (SE) change in SU from month 12 to 24 was −1.1 (0.2) mg/dL in control/DE and 0.1 (0.2) mg/dL in DE/DE group (p<0.001). There was a significant reduction in the percentage of individuals having a gout flare in the month prior to months 12 and 24 compared with baseline in both groups and in mean tophus size over 24 months, but no difference between randomised groups. There were similar numbers of AEs and serious adverse events between groups.ConclusionsThe majority of people with gout tolerate higher than creatinine clearance-based allopurinol dose and achieve and maintain target SU. Slow allopurinol DE may be appropriate in clinical practice even in those with kidney impairment.Trial registration numberACTRN12611000845932

scholarly journals Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

2021 ◽  
Author(s):  
Kathryn E. Stephenson ◽  
Boris Julg ◽  
C. Sabrina Tan ◽  
Rebecca Zash ◽  
Stephen R. Walsh ◽  
...  
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Adverse Events ◽  
Antiviral Activity ◽  
Controlled Trial ◽  
Phase 1 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Cell Counts ◽  
Hiv 1

AbstractHuman immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg–1 in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg–1 in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4+ T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4+ T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD

2018 ◽  
Vol 24 (2) ◽  
pp. 318-325 ◽  
Author(s):  
Judy P. M. van Stralen
Keyword(s):  
Executive Function ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
P Value ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Stimulant Therapy

Objective: To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD. Method: In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs. Results: Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003). There were no serious adverse events and no new safety signals. Conclusion: Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.

Effectiveness of enteral ivabradine for heart rate control in septic shock: A randomised controlled trial

2021 ◽  
pp. 0310057X2110099
Author(s):  
Priyankar K Datta ◽  
Vimi Rewari ◽  
Rashmi Ramachandran ◽  
Preet M Singh ◽  
Bikash R Ray ◽  
...  
Keyword(s):  
Heart Rate ◽  
Septic Shock ◽  
Adverse Events ◽  
Standard Therapy ◽  
Controlled Trial ◽  
Cardiac Pacemaker ◽  
Stroke Volume Index ◽  
Volume Index ◽  
Serious Adverse Events ◽  
Group I

Persistent tachycardia in patients with septic shock predicts poor outcome. This study sought to investigate the effect of the cardiac pacemaker current inhibitor ivabradine on heart rate and cardio-circulatory function in patients with septic shock. After informed consent, 60 patients with septic shock and persistent tachycardia (heart rate >95 /minute) were prospectively randomly assigned to receive either standard therapy for septic shock (group S) or standard therapy along with enteral ivabradine (group I) for the initial 96 hours after enrolment. Primary outcome was the difference in heart rate between the two groups during the first 96 hours. Secondary outcomes included the effect of ivabradine on haemodynamic, oxygenation, myocardial function and organ function parameters, incidence of adverse events and 30-day overall survival. Heart rate was lower in group I compared to group S (median difference in area under the curve –25.6 (95% confidence intervals –31.4 to –15.9) /minute; P <0.001). Vasopressor requirements, blood lactate levels, Sequential Organ Failure Assessment scores and E/e′ ratio were lower in group I compared to group S. Stroke volume index and ejection fraction were higher in group I while cardiac index and oxygen delivery parameters were maintained similar to group S. There was no difference in 30-day mortality or in the incidence of serious adverse events. Enteral ivabradine is effective in reducing heart rate, and improving haemodynamic parameters and cardiac function in patients with septic shock and persistent tachycardia, without increasing the incidence of adverse events.

scholarly journals Immunogenicity and Safety after Booster Vaccination of Diphtheria, Tetanus, and Acellular Pertussis in Young Adults: an Open Randomized Controlled Trial in Japan

2013 ◽  
Vol 20 (12) ◽  
pp. 1799-1804 ◽  
Author(s):  
Megumi Hara ◽  
Kenji Okada ◽  
Yuko Yamaguchi ◽  
Shingo Uno ◽  
Yasuko Otsuka ◽  
...  
Keyword(s):  
Young Adults ◽  
Adverse Events ◽  
Pertussis Vaccine ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Booster Vaccination ◽  
Acellular Pertussis Vaccine ◽  
Serious Adverse Events ◽  
Booster Immunization ◽  
Registration Number

ABSTRACTThe recent increase of pertussis in young adults in Japan is hypothesized to be due in part to waning protection from the acellular pertussis vaccine. While a booster immunization may prevent an epidemic of pertussis among these young adults, little is known about the safety and immunogenicity of such a booster with the diphtheria, tetanus, and acellular pertussis vaccine (DTaP), which is currently available in Japan. One hundred and eleven medical students with a mean age of 19.4 years were randomly divided into 2 groups of 55 and 56 subjects and received, respectively, 0.2 or 0.5 ml of DTaP. Immunogenicity was assessed by performing the immunoassay using serum, and the geometric mean concentration (GMC), GMC ratio (GMCR), seropositive rate, and booster response rate were calculated. Adverse reactions and adverse events were monitored for 7 days after vaccination. After booster vaccination in the two groups, significant increases were found in the antibodies against pertussis toxin, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid, and the booster response rates for all subjects reached 100%. The GMCs and GMCRs against all antigens were significantly higher in the 0.5-ml group than in the 0.2-ml group. No serious adverse events were observed. Frequencies of local reactions were similar in the 2 groups, although the frequency of severe local swelling was significantly higher in the 0.5-ml group. These data support the acceptability of booster immunization using both 0.2 and 0.5 ml of DTaP for young adults for controlling pertussis. (This study was registered at UMIN-CTR under registration number UMIN000010672.)

scholarly journals Saccharomyces boulardii to Prevent Antibiotic-Associated Diarrhea: A Randomized, Double-Masked, Placebo-Controlled Trial

2016 ◽  
Vol 3 (1) ◽  
Author(s):  
Stephan Ehrhardt ◽  
Nan Guo ◽  
Rebecca Hinz ◽  
Stefanie Schoppen ◽  
Jürgen May ◽  
...  
Keyword(s):  
Placebo Group ◽  
Clostridium Difficile ◽  
Adverse Events ◽  
Antibiotic Treatment ◽  
Controlled Trial ◽  
Saccharomyces Boulardii ◽  
Serious Adverse Events ◽  
Antibiotic Associated Diarrhea ◽  
Clostridium Difficile Associated Diarrhea ◽  
Systemic Antibiotic Treatment

Abstract Background.  Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods.  We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results.  Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477 participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P = .87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval, .55–1.90; P = .94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions.  We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment. ClinicalTrials.gov Identifier.  NCT01143272.

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