scholarly journals Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study

BMJ ◽  
2019 ◽  
pp. l5337 ◽  
Author(s):  
Gunilla Skoog Ståhlgren ◽  
Mia Tyrstrup ◽  
Charlotta Edlund ◽  
Christian G Giske ◽  
Sigvard Mölstad ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Day Treatment ◽  
Group A Streptococci ◽  
Open Label ◽  
Link Type ◽  
Penicillin V ◽  
Bacteriological Eradication ◽  
Group A ◽  
Randomised Controlled

Abstract Objective To determine whether total exposure to penicillin V can be reduced while maintaining adequate clinical efficacy when treating pharyngotonsillitis caused by group A streptococci. Design Open label, randomised controlled non-inferiority study. Setting 17 primary healthcare centres in Sweden between September 2015 and February 2018. Participants Patients aged 6 years and over with pharyngotonsillitis caused by group A streptococci and three or four Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils, and absence of cough). Interventions Penicillin V 800 mg four times daily for five days (total 16 g) compared with the current recommended dose of 1000 mg three times daily for 10 days (total 30 g). Main outcome measures Primary outcome was clinical cure five to seven days after the end of antibiotic treatment. The non-inferiority margin was prespecified to 10 percentage points. Secondary outcomes were bacteriological eradication, time to relief of symptoms, frequency of relapses, complications and new tonsillitis, and patterns of adverse events. Results Patients (n=433) were randomly allocated to the five day (n=215) or 10 day (n=218) regimen. Clinical cure in the per protocol population was 89.6% (n=181/202) in the five day group and 93.3% (n=182/195) in the 10 day group (95% confidence interval −9.7 to 2.2). Bacteriological eradication was 80.4% (n=156/194) in the five day group and 90.7% (n=165/182) in the 10 day group. Eight and seven patients had relapses, no patients and four patients had complications, and six and 13 patients had new tonsillitis in the five day and 10 day groups, respectively. Time to relief of symptoms was shorter in the five day group. Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events. Conclusions Penicillin V four times daily for five days was non-inferior in clinical outcome to penicillin V three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci. The number of relapses and complications did not differ between the two intervention groups. Five day treatment with penicillin V four times daily might be an alternative to the currently recommended 10 day regimen. Trial registration EudraCT 2015-001752-30; ClinicalTrials.gov NCT02712307 .

Clinical Cure of Group A Streptococcal Pharyngotonsillitis with a 5 day treatment of Penicillin V

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Carol Motley ◽  
Soo-Ryun Ahn ◽  
Sitembile Lee
Keyword(s):  
Clinical Cure ◽  
Day Treatment ◽  
Penicillin V ◽  
Group A

scholarly journals Effect of ‘hand and foot acupuncture with twelve needles’ on hemiplegia patients with ‘qi deficiency and blood stasis’ syndrome in the convalescent stage of Ischaemic stroke: study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wei-Hao Fang ◽  
Gui-Ling Wang ◽  
Qiang Liu ◽  
Xiao Ding ◽  
Zhen-Yao Wang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Controlled Clinical Trial ◽  
Link Type ◽  
Stroke Study ◽  
Group A ◽  
Randomised Controlled ◽  
Convalescent Stage

Abstract Background Hemiplegia is a common sequela after stroke, and acupuncture is one of the most common physical therapies used to treat hemiplegia during the recovery stage after ischaemic stroke. ‘Hand and foot acupuncture with twelve needles’ is an acupuncture treatment performed after stroke. The principal objective of this study is to assess the efficacy and safety of ‘hand and foot acupuncture with twelve needles’ for hemiplegia in the convalescent stage of ischaemic stroke. Methods This is the protocol for a randomised, controlled clinical trial with two groups: a ‘hand and foot acupuncture with twelve needles’ group and a routine acupuncture group. A total of 208 participants will be randomly assigned to two different groups in a 1:1 ratio and will undergo conventional rehabilitation. Limb function will be evaluated by the simplified Fugl-Meyer assessment scale, Barthel Index, modified Ashworth scale and National Institute of Health stroke scale. The participants will be evaluated at baseline (on the day of enrolment) and followed up at 2 weeks, 1 month, 2 months and 3 months after enrolment. Discussion The results of this study will provide evidence on the effectiveness of ‘hand and foot acupuncture with twelve needles’ in the treatment of limb dysfunction that can be used for future evaluations. Trial registration Chictr.org.cnChiCTR1900021774. Registered on 8 March 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

ERYTHROMYCIN PROPIONATE AND POTASSIUM PENICILLIN V IN THE TREATMENT OF GROUP A STREPTOCOCCAL PHARYNGITIS

PEDIATRICS ◽  
1963 ◽  
Vol 31 (1) ◽  
pp. 22-28
Author(s):  
Maxwell Stillerman ◽  
Stanley H. Bernstein ◽  
Martha Smith ◽  
Jack D. Gorvoy
Keyword(s):  
Relative Effectiveness ◽  
Streptococcal Pharyngitis ◽  
Group A Streptococci ◽  
Cure Rate ◽  
Acute Pharyngitis ◽  
Penicillin V ◽  
Daily Dose ◽  
Group A ◽  
Potassium Penicillin

The relative effectiveness of erythromycin propionate and K penicillin V in two dosage schedules was evaluated in the treatment of 261 cases of acute pharyngitis from which Group A hemolytic streptococci were recovered from December, 1958, to June, 1959. Erythromycin propionate, in a daily dose of 30 mg/kg up to 1.0 gm, and K penicillin V, in daily doses of 375 mg and 750 mg, were administered orally for 10 days. The adjusted bacterial cure rate was 78% among 86 patients treated with erythromycin, 72% among 102 patients treated with K penicillin V, 375 mg, and 88% among 73 patients treated with K penicillin V, 750 mg. The data indicate that K penicillin V was more effective in eradicating Group A streptococci from the pharynx in a daily dose of 750 mg than 375 mg, and suggest that erythromycin propionate in the dosage used, was less effective than K penicillin V, 750 mg, but equally as effective as K penicillin V, 375 mg daily. The incidence, time of occurrence, and results of retreatments of bacterial relapses are presented, and two possible causes of relapses are considered.

scholarly journals A phase I study of a dual PI3-kinase/mTOR inhibitor BEZ235 in adult patients with relapsed or refractory acute leukemia

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fabian Lang ◽  
Lydia Wunderle ◽  
Susanne Badura ◽  
Eberhard Schleyer ◽  
Monika Brüggemann ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Leukemia ◽  
Phase I ◽  
Mtor Inhibitor ◽  
Prolonged Treatment ◽  
Small Subset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Efficient Treatment ◽  
Link Type

Abstract Background Combined inhibition of phosphatidylinositol 3-kinase (PI3K) and the mammalian target of rapamycin (mTOR) complexes may be an efficient treatment for acute leukemia. The primary objective of this phase I single center open label study was to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the dual pan-class I PI3K and mTOR inhibitor BEZ235 in patients with advanced leukemia. Methods Herein patients > 18 years of age who had relapsed or showed refractory leukemia were treated with BEZ235 (orally at 300–400 mg BID (cohort − 1/1)) to assess safety, tolerability, preliminary efficacy and pharmacokinetic (PK). Adverse events data and serious adverse events were analyzed and haematological and clinical biochemistry toxicities were assessed from laboratory test parameters. Response was assessed for the first time at the end of cycle 1 (day 29) and after every subsequent cycle. Pharmacokinetic and pharmacodynamic analyses of BEZ235 were also included (BEZ235 plasma levels, phosphorylation of AKT, S6 and 4EBP1). On statistics this trial is a multiple ascending dose study in which a following variant of the 3 + 3 rule (“Rolling Six”), a minimum of 6 and a maximum of 12 patients was recruited for the dose escalation and another 5 were planned for the expansion phase. Results Twenty-four patients with ALL (n = 11) or AML (n = 12) or CML-BP (n = 1) were enrolled. All patients had failed one (n = 5) or more lines of therapy (n = 5) and 14 patients were in refractory / refractory relapse. No formal MTD was defined, stomatitis and gastrointestinal toxicity at 400 mg BID dose was considered incompatible with prolonged treatment. The RP2D of BEZ235 was defined as 300 mg BID. Four of 24 patients showed clinical benefit. Twenty-two of 24 patients discontinued because of progression, (median time to progression 27 days (4d-112d). There was no association between PK parameters and efficacy or tolerability. Conclusions Combined inhibition of PI3K and mTOR inhibits a clinically meaningful driver pathway in a small subset of patients with ALL, with no benefit in patients with AML. Trial registration ClinicalTrials.gov, identifier NCT01756118. retrospectively registered 19th December 2012, https://clinicaltrials.gov/ct2/show/NCT01756118.

scholarly journals Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Sarah E. Goldberg ◽  
◽  
Veronika van der Wardt ◽  
Andy Brand ◽  
Clare Burgon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Falls Prevention ◽  
Feasibility Trial ◽  
Moderate Intensity ◽  
Eligibility Criteria ◽  
Intervention Delivery ◽  
Link Type ◽  
Early Dementia ◽  
Randomised Controlled

Abstract Background We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. Methods We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. Results Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. Conclusion We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. Trial registration ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

scholarly journals Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e041520
Author(s):  
Elsa Tavernier ◽  
Bairbre McNicholas ◽  
Ivan Pavlov ◽  
Oriol Roca ◽  
Yonatan Perez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Small Sample ◽  
High Flow ◽  
Occurrence Rate ◽  
Prone Positioning ◽  
Open Label ◽  
Link Type ◽  
Randomised Controlled ◽  
Nasal High Flow Therapy

IntroductionProne positioning (PP) is an effective first-line intervention to treat patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation, as it improves gas exchanges and reduces mortality. The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size. High-level evidence of awake PP for hypoxaemic patients with COVID-19 patients is still lacking.Methods and analysisThe protocol of this meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled open label superiority trials. This design is particularly adapted to a rapid scientific response in the pandemic setting. It will take place in multiple sites, among others in USA, Canada, Ireland, France and Spain. Patients will be followed up for 28 days. Patients will be randomised to receive whether awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy. Primary outcome is defined as the occurrence rate of tracheal intubation or death up to day 28. An interim analysis plan has been set up on aggregated data from the participating research groups.Ethics and disseminationEthics approvals were obtained in all participating countries. Results of the meta-trial will be submitted for publication in a peer-reviewed journal. Each randomised controlled trial was registered individually, as follows: NCT04325906, NCT04347941, NCT04358939, NCT04395144 and NCT04391140.

Persistence of group A streptococci as related to penicillinase-producing staphylococci: Comparison of penicillin V potassium and sodium nafcillin

1967 ◽  
Vol 71 (1) ◽  
pp. 132-137 ◽  
Author(s):  
Milton Markowitz ◽  
Irving Kramer ◽  
Eugene Goldstein ◽  
Anthony Perlman ◽  
Donald Klein ◽  
...  
Keyword(s):  
Group A Streptococci ◽  
Penicillin V ◽  
Group A ◽  
Sodium Nafcillin
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