A Guide For Multicentre Trials in High-Burden Countries
Clinical Medicine
JCI Insight. 2017;2(7):e91963.
Researchers are devising a clinical-trial protocol to test three medicines in Africa's latest outbreak
Nature doi: 10.1038/d41586-018-06132-7
The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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A lot of research articles concerning SARS-CoV-2/COVID-19 are published every day. Many of them, so-called pre-prints, are not reviewed in a professional reviewing process at the time of publication. Others are already reviewed and published in well-known journals. Collabovid helps researchers to id...entify the most relevant information by using Natural Language Processing. You can search for any topic you want below. Visit search to review all articles or browse a list of predefined categories. For additional help visit the frequently asked questions.
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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...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.
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As the global community aims to fulfill its commitments to the UN Sustainable Development Goals, and the achievement of universal health coverage, dozens of countries have committed to the expansion of community health workers (CHWs) as the front line of their healthcare systems [1, 2]. Robust resea...rch demonstrates CHWs improve access to care, reduce maternal, newborn, and child mortality, improve clinical outcomes for chronic diseases, and prevent disease outbreaks [3].
To support the operationalization of quality CHW program design and implementation, USAID, UNICEF, the Community Health Impact Coalition, and Initiatives Inc. have updated and adapted the Community Health Worker Assessment and Improvement Matrix (CHW AIM) Program Functionality Matrix [12]. This tool can be used to identify design and implementation gaps in both small- and national-scale CHW programs, and close gaps in policy and practice.
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This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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Buruli ulcer is caused by infection with Mycobacterium ulcerans. The disease is reported in more than 33 countries worldwide, but only about half of these countries regularly report data to WHO; most cases are reported from subregions of West and Central Africa. The mode of transmission is not known....
About half of those affected are children aged under 15 years; there is no gender difference. Diagnosis is based mainly on clinical and epidemiological characteristics. Of the four methods used for laboratory confirmation (microscopy, polymerase chain reaction (PCR), histopathology and culture), PCR is the most rapid and widely used. Other rapid methods for detection of mycolactone in lesions from suspected cases, such as fluorescent thin-layer chromatography, are under evaluation in four countries in Africa.
Research to develop point-of-care tests is in progress. Treatment of Buruli ulcer comprises 8 weeks of combined antibiotics (rifampicin and clarithromycin). Complementary therapies such as wound care, skin graft and prevention of disability are needed in some cases to ensure full recovery.
The target set by the World Health Organization (WHO) for control of Buruli ulcer is for countries to achieve a rate of case confirmation by PCR of at least 70%. All endemic countries have at least one PCR facility to support confirmation of cases. However, most countries in the WHO African Region have not been able to reach the target, and the rate of case confirmation has been declining
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The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects. Advances in this area have been compromised by gaps... in our knowledge of disease pathogenesis, parasite biology and drug activity. Nevertheless, several factors have come together to create a more optimistic scenario. Drug-based research has become more systematic, with increased collaborations between the academic and commercial sectors, often within the framework of not-for-profit consortia. High-throughput screening of compound libraries is being widely applied, and new technical advances are helping to streamline the drug development pipeline. In addition, drug repurposing and optimisation of current treatment regimens, informed by laboratory research, are providing a basis for new clinical trials. Here, we will provide an overview of the current status of Chagas disease drug development, highlight those areas where progress can be expected, and describe how fundamental research is helping to underpin the process.
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Leptospirosis is a perplexing conundrum for many. In the existing literature, the pathophysiological mechanisms pertaining to leptospirosis is still not understood in full. Considered as a neglected tropical zoonotic disease, leptospirosis is culminating as a serious problem worldwide, seemingly exi...sting as co-infections with various other unrelated diseases, including dengue and malaria. Misdiagnosis is also common as non-specific symptoms are documented extensively in the literature. This can easily lead to death, as the severe form of leptospirosis (Weil’s disease) manifests as a complex of systemic complications, especially renal failure. The virulence of Leptospira sp. is usually attributed to the outer membrane proteins, including LipL32. With an armament of virulence factors at their disposal, their ability to easily adhere, invade and replicate within cells calls for a swift refinement in research progress to establish their exact pathophysiological framework. As an effort to reconstitute the current knowledge on leptospirosis, the basis of leptospiral infection, including its risk factors, classification, morphology, transmission, pathogenesis, co-infections and clinical manifestations are highlighted in this review. The various diagnostic techniques are also outlined with emphasis on their respective pros and cons.
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The objectives of the meeting were:
1. To update the current status of the disease transmission, country capacities and plans for tackling the disease.
2. To understand the epidemiology including disease distribution and risk, the models
for estimating under-detection, the geographical variati...ons of in clinical presentation,
the roles of domestic and wild animal reservoirs and the subsequent different
transmission patterns and control approaches, including vector control.
3. To update current research and development efforts for improving diagnostic and
treatment tools.
4. To define the goals for achieving the control of r-HAT, the need for a multisectoral
approach and to discuss the strategy for controlling r-HAT and the coordination
mechanisms.
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Cutaneous Leishmaniasis (CL) is a painful disease that exerts a serious toll on societies around the world that are afflicted by it. Although not life-threatening, the skin ulcers and scars it causes can lead to isolation and psychosocial pathologies due to social stigma, and its occurrence is often... associated with regional conflicts. The Cutaneous Leishmaniasis Research Meeting was held on December 7, 2020, with participation by basic researchers, clinical researchers, and drug discovery experts involved in research and development related to CL under the auspices of the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine. In addition, the CL Webinar was held on March 5, 2021, hosted by the Graduate School of Tropical Medicine and Global Health, co-hosted by the Institute of Tropical Medicine, and supported by Médecins Sans Frontières and DNDi.
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Cutaneous Leishmaniasis (CL) is a painful disease that exerts a serious toll on societies around the world that are afflicted by it. Although not life-threatening, the skin ulcers and scars it causes can lead to isolation and psychosocial pathologies due to social stigma, and its occurrence is often... associated with regional conflicts. The Cutaneous Leishmaniasis Research Meeting was held on December 7, 2020, with participation by basic researchers, clinical researchers, and drug discovery experts involved in research and development related to CL under the auspices of the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine. In addition, the CL Webinar was held on March 5, 2021, hosted by the Graduate School of Tropical Medicine and Global Health, co-hosted by the Institute of Tropical Medicine, and supported by Médecins Sans Frontières and DNDi.
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Cutaneous Leishmaniasis (CL) is a painful disease that exerts a serious toll on societies around the world that are afflicted by it. Although not life-threatening, the skin ulcers and scars it causes can lead to isolation and psychosocial pathologies due to social stigma, and its occurrence is often... associated with regional conflicts. The Cutaneous Leishmaniasis Research Meeting was held on December 7, 2020, with participation by basic researchers, clinical researchers, and drug discovery experts involved in research and development related to CL under the auspices of the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine. In addition, the CL Webinar was held on March 5, 2021, hosted by the Graduate School of Tropical Medicine and Global Health, co-hosted by the Institute of Tropical Medicine, and supported by Médecins Sans Frontières and DNDi.
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Cutaneous Leishmaniasis (CL) is a painful disease that exerts a serious toll on societies around the world that are afflicted by it. Although not life-threatening, the skin ulcers and scars it causes can lead to isolation and psychosocial pathologies due to social stigma, and its occurrence is often... associated with regional conflicts. The Cutaneous Leishmaniasis Research Meeting was held on December 7, 2020, with participation by basic researchers, clinical researchers, and drug discovery experts involved in research and development related to CL under the auspices of the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine. In addition, the CL Webinar was held on March 5, 2021, hosted by the Graduate School of Tropical Medicine and Global Health, co-hosted by the Institute of Tropical Medicine, and supported by Médecins Sans Frontières and DNDi.
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One of the main aims of the WHO Global Initiative for Childhood Cancer and the CureAll Americas framework is to strengthen centers of excellence and promote the training of the health workforce, especially pediatric oncology nurses, specialized in nursing care for children and adolescents with cance...r and their families. These health personnel provide compassionate, non traumatic, complex, continuous, ethical, conscious patient- and family-centered care in order to meet the physical, emotional, psychosocial, and cultural needs of the people involved. This publication is aimed at health administration teams, hospital management teams, and professional pediatric oncology nursing groups. Its objective is to identify, systematize, and consolidate available evidence on the scope of pediatric oncology nursing practice in Latin America and the Caribbean based on core competencies, in order to incorporate them into clinical practice, teaching, and research. The preparation process included a systematic review aimed at finding the best evidence on this subject. Patient- and family centered care and the conceptual model of competencies for teenagers and young adults with cancer, developed by the Teenage Cancer Trust with the support of the Royal College of Nursing, were the theoretical foundations supporting the systematization of recommendations.
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