A systematic review of randomized controlled efficacy trials | REPORT -
DEPARTMENT OF CHILD AND ADOLESCENT HEALTH AND DEVELOPMENT
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 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
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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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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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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This special issue on Newborn Health in Global Health Action is being launched to share the experience of how to scale up a cost-effective package of newborn care that involves families, community health workers and health facilities. The results of this community randomized trial, the Uganda Newbor...n Study (UNEST), show that home visits in pregnancy and soon after delivery resulted in improved breastfeeding practices, skin-to-skin care immediately after birth, delaying a baby’s first bath, and hygienic care of the baby’s umbilical cord among the poorest households with lowest access to care.
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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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The COPSI project is divided into three phases: the first in which the intervention is developed, the second in which researchers evaluate the intervention in a randomised controlled trial, and the final one in which the results of the trial are analysed and disseminated.
A COPSI resource kit has ...been developed comprising the COPSI training manual for the community health workers, intervention flip chart, 14 intervention handouts, recovery stories booklet and videos about people with schizophrenia and their families telling their stories of illness and recovery in a deeply personal way.
To access the videos, please click to http://www.sangath.in/copsi/ to watch the video based in Tamil Nadu and to watch the video based in Maharashtra.
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WHO recommends that pre-exposure prophylaxis (PrEP) be offered as an additional prevention choice for HIV-negative individuals at substantial risk of HIV infection as part of combination prevention approaches.
HIV drug resistance has been rarely reported among PrEP users who tested HIV positive i...n randomized controlled trials or open-label studies. However, PrEP-selected HIV drug resistance could potentially negatively impact the effectiveness of treatment options among PrEP users who acquire HIV, since there is a potential for overlapping resistance profiles between antiretroviral drugs used for both PrEP and first-line antiretroviral therapy.
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The method, entitled “elicit-provide-elicit”, is a patient centred method which is adaptable to a range of clinical situations. Recent clinical trials show that the introduction of advanced communication skills based on this method in general practice allows primary care physicians to prescribe... significantly less antibiotics while maintaining a high degree of patient satisfac-tion, without impacting patient recovery time and consultation times.
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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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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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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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Exciting news this week with @Pfizer reporting their mRNA vaccine is 90% effective, based on their Phase III clinical trial data. Dr. Tom looks inside the virus to break down how mRNA vaccines work, and whether news this promising means we can finally relax.
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 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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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.