: a cluster-randomised trial.
Lancet Glob Health 2020; 8: e387–98
Researchers are devising a clinical-trial protocol to test three medicines in Africa's latest outbreak
Nature doi: 10.1038/d41586-018-06132-7
A systematic review of randomized controlled efficacy trials | REPORT -
DEPARTMENT OF CHILD AND ADOLESCENT HEALTH AND DEVELOPMENT
The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat...ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
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WHO and UNITAID
in collaboration with IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) network, PENTA (Paediatric European Network for Treatment of AIDS) foundation and experts from the Paediatric Antiretroviral Working Group
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 clarithromycin 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.
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This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field application rates of new molluscicide products for control of schistosomiasis.
COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Repub...lic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.
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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...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.
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Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported ...serious adverse events (SAEs).
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As of January 20, 2021 the Covid-19 - living NMA initiative collected 150 RCTs and 36 non-randomised studies of vaccines from the ICTRP. 93 of these trials are recruiting patients.
10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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As of 31 October 2020 This is the tenth edition of this summary of rapid systematic reviews, which includes the results of a rapid systematic review of currently available literature. More than 200 therapeutic options or their combinations are being investigated in more than 1,700 clinical trials. I...n this review, 46 therapeutic options are examined. The Pan American Health Organization (PAHO) is continually monitoring ongoing research on any possible therapeutic options. As evidence emerges, then PAHO will immediately assess and update its position, and particularly as it applies to any special sub-group populations such as children, expectant mothers, those with immune conditions, etc.
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This article is part two 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. This article focuses on the ingredients in a vaccine and the three clinical trial phases. Part three outlines the nex...t part of the vaccine journey: the steps from completing the clinical trial phases through to distribution
Available in English, French, Spanish, Arabic, Chinese and Russian
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Africa Centers for Disease Control and Prevention (Africa CDC) is aware of the media releases of the preliminary results of a large randomized clinical trial conducted in the United Kingdom, which included dexamethasone, a corticosteroid, as one of the drugs used for the treatment of COVID-19 patien...ts. The investigators reported that administration of oral or injectable dexamethasone resulted in about one-third reduction in mortality among COVID-19 patientsi that required mechanical ventilation and about one-fifth for patients requiring oxygen.
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Sleeping sickness is controlled by case detection and treatment but this often only reaches less than 75% of the population. Vector control is capable of completely interrupting HAT transmission but is not used because of expense. We conducted a full scale field trial of a refined vector control tec...hnology. From preliminary trials we determined the number of insecticidal tiny targets required to control tsetse populations by more than 90%. We then carried out a full scale, 500 km2 field trial covering two HAT foci in Northern Uganda (overall target density 5.7/km2). In 12 months tsetse populations declined by more than 90%. A mathematical model suggested that a 72% reduction in tsetse population is required to stop transmission in those settings. The Ugandan census suggests population density in the HAT foci is approximately 500 per km2. The estimated cost for a single round of active case detection (excluding treatment), covering 80% of the population, is US$433,333 (WHO figures). One year of vector control organised within country, which can completely stop HAT transmission, would cost US$42,700. The case for adding this new method of vector control to case detection and treatment is strong. We outline how such a component could be organised.
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Interim guidance 2 march 2021
Current use of drugs to prevent COVID-19 is variable, reflecting large-scale uncertainty. Numerous randomized trials of many different drugs are underway to inform practice. This first version of the Drugs to prevent COVID-19: A WHO living guideline contains new inform...ation and a recommendation on hydroxychloroquine. It follows the publication of six trials synthesized in a living network meta-analysis (NMA).
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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).
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The Global Programme to Eliminate Lymphatic Filariasis (LF) is using mass drug administration (MDA) of antifilarial medications to treat filarial infections, prevent disease and interrupt transmission. Almost 500 million people receive these medications each year. Clinical trials have recently shown... that a single dose of a triple-drug combination comprised of ivermectin, diethylcarbamazine and albendazole (IDA) is dramatically superior to widely used two-drug combinations for clearing larval filarial parasites from the blood of infected persons. A large mul-
ticenter community study showed that IDA was well-tolerated when it was provided as MDA. IDA was rapidly advanced from clinical trial to policy and implementation; it has the potential to accelerate LF elimination in many endemic countries.
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