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The paper provides the rationale for these recommendations, which are based on analyses of data from the TRACT trial.
n this study, low-dose azithromycin did not meet the prespecified non-inferiority margin compared with standard-dose azithromycin in achieving clinical and serological cure in PCR-confirmed active yaws. Only a single participant (with presumed latent yaws) had definitive serological failure. This wo
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rk suggests that 20 mg/kg of azithromycin is probably effective against yaws, but further data are needed.
more
Soil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, particularly among children. Mathematical models suggest it may be possible to interrupt the transmission of STH in a community by e
...
xpanding mass drug administration (MDA) from targeted high-risk groups (primarily school-aged children and women of child-bearing age) to all community members with high coverage. The DeWorm3 Project will test the feasibility of this approach to interrupting the transmission of STH using a series of cluster randomized trials in Benin, India and Malawi. Each study area (population 80,000) will be divided into 40 clusters and randomized to community-wide or standard-of-care targeted MDA for three years. Two years following the final round of MDA, prevalence of STH will be compared between arms and transmission interruption assessed in each cluster. The DeWorm3 trials will provide stakeholders with information regarding the potential to switch from STH control to a more ambitious and sustainable strategy.
more
The Lancet, Early Online Publication, 11 July 2014
doi:10.1016/S0140-6736(14)60934-X
*Free registration is required to view this article
A living WHO guideline on drugs for covid-19
recommended
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE
...
COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
more
The Asthma Control Questionnaire (ACQ)1 was developed and validated to measure the primary clinical goal of asthma management as identified by international guidelines. They indicate that to achieve good control, treatment should minimise day and night time symptoms, activity limitation, airway narr
...
owing and rescue bronchodilator use and thus reduce the risk of life-threatening exacerbations and long-term morbidity. The importance of including all aspects of control in the assessment of individual patients was emphasised by a recent factor analysis which showed that clinical asthma is composed of distinct components which are not closely correlated with each other.6 However, in some studies it may not be possible to collect airway calibre or short-acting β2-agonists data. Previous analysis of non-clinical trial data suggested that when ACQ scores are analysed as group data, the heterogeneity of the way in which individual patients present with inadequate control is lost in the estimation of the mean and the need to measure each individual component of asthma control may become unnecessary. In this analysis, ACQ data from a clinical trial was used to evaluate the measurement properties (reliability, responsiveness, validity and interpretability), of three shortened versions of the ACQ. In addition, we have examined whether the precision and accuracy of estimating the effect of the intervention on asthma control was maintained when the two questions concerning airway calibre and short-acting β2-agonists use were omitted from the trial analysis.
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August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and efficac
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y of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
more
High levels of storage iron may increase malaria susceptibility. This risk has not been investigated in semi-immune adolescents. We investigated whether baseline iron status of nonpregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the fo
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llowing rainy season. For this prospective study, we analysed data from an interim safety survey, conducted six months into a randomised iron supplementation trial. We used logistic regression to model the risk of P. falciparum infection prevalence by microscopy, the pre-specified interim safety outcome, in relation to iron status, nutritional indicators and menarche assessed at recruitment.
more
Learn what scientists look for in the different phases of a clinical trial for a vaccine. What does it mean when a vaccine trial is halted due to an adverse event? WHO’s Dr Kate O’Brien explains
...
in Science in 5 this week
more
The results of the SHINE trial have been published in the NEJM today. SHINE looked at whether treatment for children with minimal TB could be reduced from 6 months to 4 months. It found that the four month treatment was as good as the standard six m
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onths treatment for children with minimal TB
more
COVID-19 vaccine tracker and landscape
recommended
The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-
...
clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
more
Researchers are devising a clinical-trial protocol to test three medicines in Africa's latest outbreak
Nature doi: 10.1038/d41586-018-06132-7
Phillips and colleagues have shown that rifampicin combined with clarithromycin is non-inferior to RS8, and is safer. This much anticipated trial provides us with a high degree of confidence that an 8-week course of oral rifampicin and clarithromyci
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n should now be the cornerstone of the treatment of Buruli ulcer everywhere. However, this finding does not mean that
Buruli ulcer is cured at 8 weeks.
more
DOI: 10.5772/intechopen.102891Little progress has been made since the 1960s and 19. 70s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and opera
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tional challenges in the clinical drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
more
PLOS ONE | DOI:10.1371/journal.pone.0142290 November 9, 2015; 1 / 16
Clinical Presentation of T.b. rhodesiense Sleeping Sickness in Second Stage Patients from Tanzania and Uganda
Kuepfer, I.; Hhary, EP.; Mpairwe, A.; Edielu, A.; Burri, C.; Blum, JA.
PLOS Neglected Tropical Diseases
(2011)
CC
A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d
...
ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
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To give you a better idea of when and how psychotherapy can help you, we have written this brochure titled Paths to Psychotherapy. While it is therefore primarily intended for people who have never been treated by a psychotherapist, the brochure can also enable those who have previously had psychoth
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erapy to find out about the range of psychotherapeutic care and assistance that is currently available. Regardless of your previous experience with psychotherapy, this brochure offers you clear information about what a mental illness is, whether scheduling an initial appointment is advisable, and the circumstances in which psychotherapeutic treatment is necessary.
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This document is part three in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. Part two focused on the ingredients in a vaccine and the three clinical
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trial phases.
This document outlines the next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
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