Study protocol: an open-label individually randomised controlled trial to assess the efficacy of artemether-lumefantrine prophylaxis for malaria among forest goers in Cambodia

IntroductionIn the Greater Mekong Subregion, adults are at highest risk for malaria. The most relevant disease vectors bite during daytime and outdoors which makes forest work a high-risk activity for malaria. The absence of effective vector control strategies and limited periods of exposure during forest visits suggest that chemoprophylaxis could be an appropriate strategy to protect forest goers against malaria.Methods and analysisThe protocol describes an open-label randomised controlled trial of artemether-lumefantrine (AL) versus multivitamin as prophylaxis against malaria among forest goers aged 16–65 years in rural northeast Cambodia. The primary objective is to compare the efficacy of the artemisinin combination therapy AL versus a multivitamin preparation as defined by the 28-day PCR parasite positivity rate and incidence of confirmed clinical malaria of any species. The sample size is 2200 patient-episodes of duration 1 month in each arm. The duration of follow-up and prophylaxis for each participant is 1, 2 or 3 consecutive 28-day periods, followed by a further 28 days of post-exposure prophylaxis, depending on whether they continue to visit the forest. Analysis will be done both by intention to treat and per protocol.Ethics and disseminationAll participants will provide written, informed consent. Ethical approval was obtained from the Oxford Tropical Research Ethics Committee and the Cambodia National Ethics Committee for Health Research. Results will be disseminated by peer-reviewed open access publication together with open data.Trial registration numberNCT04041973; Pre-result.

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Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034137 ◽

2020 ◽

Vol 10 (2) ◽

pp. e034137 ◽

Cited By ~ 1

Author(s):

Dimitris Papamargaritis ◽

Werd Al-Najim ◽

Jonathan Lim ◽

James Crane ◽

Mike Lean ◽

...

Keyword(s):

Weight Loss ◽

Randomised Controlled Trial ◽

Research Ethics ◽

Real World ◽

Regulatory Authority ◽

Controlled Trial ◽

Ethics Committee ◽

Stopping Rules ◽

Open Label ◽

Randomised Controlled

IntroductionIn the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.Methods and analysisIn this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.Ethics and disseminationThe Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.Trial registration numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

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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

10.21203/rs.3.rs-210774/v1 ◽

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.

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A pilot feasibility study of gabapentin for managing pain in children with dystonic cerebral palsy

BMC Pediatrics ◽

10.1186/s12887-021-02847-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Adrienne Harvey ◽

Mary-Clare Waugh ◽

James Rice ◽

Giuliana Antolovich ◽

Lisa Copeland ◽

...

Keyword(s):

Cerebral Palsy ◽

Pilot Study ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Primary Objective ◽

Clinical Trial Registry ◽

Open Label ◽

Pain Behaviour ◽

Adherence To Medication ◽

Randomised Controlled

Abstract Background Gabapentin is often used to manage pain in children with dystonic cerebral palsy, however the evidence for its effectiveness in this population is limited. The primary objective of this feasibility pilot study was to assess the factors which might impact on a future randomised controlled trial including the ability to recruit and retain participants, assess adherence/compliance to the prescribed intervention, and ability to complete all outcome assessments. The secondary objective was to gather preliminary evidence for the effectiveness of gabapentin at reducing pain, improving comfort and reducing dystonia in children with dystonic cerebral palsy. Methods This open label pilot study recruited children aged 5–18 years with dystonic cerebral palsy and accompanying pain affecting daily activities from four centres around Australia. Children were prescribed gabapentin for 12 weeks and were assessed at baseline, 6 weeks and 12 weeks. The primary outcome was feasibility of the protocol. Secondary outcomes were pain behaviour, pain intensity, care and comfort, individualised goal setting and dystonia severity. Results Thirteen children (mean age 10.4 years (SD 2.4yrs), 9 females) were recruited from 71 screened over 15 months. Two children withdrew while eight children experienced side effects. There were issues with adherence to medication dosage regimens and data collection. Improvements were seen in pain behaviour, comfort and pain related goals at 12 weeks. Dystonia was not significantly changed. Conclusions Whilst gabapentin has potential to improve pain and comfort in children with dystonic CP, the feasibility of implementing a definitive randomised controlled trial is low. Alternative trials designs are required to further examine the effectiveness of gabapentin in this heterogeneous population. Trial registration The trial was registered with the Australian Clinical Trial Registry (ACTRN12616000366459) on 22/03/2016 and the Therapeutic Goods Administration (CT-2016-CTN-00500-1) on 22/06/2016.

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Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)

BMJ Open ◽

10.1136/bmjopen-2018-026053 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026053 ◽

Cited By ~ 9

Author(s):

Sergio Leonardi ◽

Anna Franzone ◽

Raffaele Piccolo ◽

Eugene McFadden ◽

Pascal Vranckx ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Academic Research ◽

Coronary Intervention ◽

Ethics Committee ◽

Current Treatment ◽

Clinical Event ◽

Open Label ◽

Standard Regimen ◽

Randomised Controlled

IntroductionThe GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias.Methods and analysisWe designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria.This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events.Ethics and disseminationGLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects.Trial registration numberNCT01813435.

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