scholarly journals An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Eric P. F. Chow ◽  
Kate Maddaford ◽  
Jane S. Hocking ◽  
Catriona S. Bradshaw ◽  
Rebecca Wigan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Health Centre ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled ◽  
New Treatments ◽  
Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

Antimicrobial central venous catheters do not reduce infections in pre-term babies

BMJ ◽  
2019 ◽  
pp. l4993
Author(s):  
Rob Cook ◽  
Duncan Fortescue-Webb ◽  
Rosie Martin
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Technology ◽  
Central Venous Catheters ◽  
Central Venous ◽  
Open Label ◽  
Health Technology Assessment Programme ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

The studyGilbert R, Brown M, Rainford N et al. Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial. Lancet Child Adolesc Health 2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections

scholarly journals CASSETTE - clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Ravindra Dotel ◽  
Steven YC Tong ◽  
Asha Bowen ◽  
Jane N Nelson ◽  
Matthew VN O'Sullivan ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Methicillin Resistance ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Protein Synthesis Inhibitor ◽  
Open Label ◽  
Randomised Controlled

Abstract Background: Exotoxins are an important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this is lacking. Methods: An open label, multicenter, randomised controlled trial (RCT) will compare outcome differences in severe S. aureus infection between a standard treatment (flucloxacillin/cefazolin in methicillin-susceptible S. aureus; and vancomycin/daptomycin in methicillin-resistance S. aureus) and a standard treatment plus an additional clindamycin given for 7 days. We will include a minimum of 60 participants (both adult and children) in the pilot study. Participants will be enrolled within 72 hours of an index culture. Severe infections will include septic shock, necrotising pneumonia, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Immunosuppressed, moribund, current severe diarrhea or C. difficile infection, pregnant, and those with anaphylaxis to beta-lactams or lincosamides will be excluded. Primary outcomes measure is number of days alive and free (1 or none) of SIRS (Systemic Inflammatory Response Syndrome) within the first 14 days post randomization. Secondary outcomes measure will include all-cause mortality at 14, 42 and 90 days, time to resolution of SIRS, proportion with microbiological treatment failure, and rate of change of C-reactive protein over time. Impacts of inducible clindamycin resistance, strains types, methicillin-susceptibility, and presence of various exotoxins will also be analysed. Discussion: This study will assess the effect of adjunctive clindamycin on patient-centered outcomes in severe, toxin mediated S. aureus infections. The Pilot study will provide feasibility for a much larger RCT. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12617001416381p. Registered 06 October 2017 Keywords: Staphylococcus aureus, exotoxins, prospective studies, clindamycin, leukocidins

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

scholarly journals Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 390 (10109) ◽  
pp. 2247-2255 ◽  
Author(s):  
Ashley Woodcock ◽  
Jørgen Vestbo ◽  
Nawar Diar Bakerly ◽  
John New ◽  
J Martin Gibson ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Fluticasone Furoate ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled

scholarly journals CASSETTE - clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Ravindra Dotel ◽  
Steven YC Tong ◽  
Asha Bowen ◽  
Jane N Nelson ◽  
Matthew VN O'Sullivan ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Methicillin Resistance ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Protein Synthesis Inhibitor ◽  
Open Label ◽  
Randomised Controlled

Abstract Background Exotoxins are an important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this is lacking. Methods An open label, multicenter, randomised controlled trial (RCT) will compare outcome differences in severe S. aureus infection between a standard treatment (flucloxacillin/cefazolin in methicillin-susceptible S. aureus; and vancomycin/daptomycin in methicillin-resistance S. aureus) and a standard treatment plus an additional clindamycin given for 7 days. We will include a minimum of 60 participants (both adult and children) in the pilot study. Participants will be enrolled within 72 hours of an index culture. Severe infections will include septic shock, necrotising pneumonia, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Immunosuppressed, moribund, current severe diarrhea or C. difficile infection, pregnant, and those with anaphylaxis to beta-lactams or lincosamides will be excluded. Primary outcomes measure is number of days alive and free (1 or none) of SIRS (Systemic Inflammatory Response Syndrome) within the first 14 days post randomization. Secondary outcomes measure will include all-cause mortality at 14, 42 and 90 days, time to resolution of SIRS, proportion with microbiological treatment failure, and rate of change of C-reactive protein over time. Impacts of inducible clindamycin resistance, strains types, methicillin-susceptibility, and presence of various exotoxins will also be analysed. Discussion This study will assess the effect of adjunctive clindamycin on patient-centered outcomes in severe, toxin mediated S. aureus infections. The Pilot study will provide feasibility for a much larger RCT. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12617001416381p. Registered 06 October 2017

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