Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati...ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
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Leishmaniasis is a climate-sensitive disease. Changes in temperature, rainfall, and humidity can have strong impacts on
the sandfly vector, altering their distribution and influencing their survival and population sizes. Increased temperatures shorten vector development time, reduce Leishmania para...site incubation time, and increase vector biting rates, allowing transmission
in areas not previously endemic for the disease. Poor and
marginalized communities will be hit disproportionately harder by
the effects of climate change, and droughts, famines, and floods
can also lead to displacement and migration of immunologically
naive people to areas where leishmaniasis is endemic, posing a
threat of leishmaniasis outbreaks.
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La leishmaniasis es una enfermedad tropical desatendida sensible
al clima, trasmitida por la picadura de insectos flebótomos y
se calcula que amenaza a mil millones de personas en todo el mundo.
Esta enfermedad altamente compleja se presenta de varias formas
clínicas, causadas por 20 especies ...del parásito Leishmania.
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Visceral leishmaniasis, the most severe form of leishmaniasis also known as kala-azar, is a life-threatening disease caused by Leishmania parasites which are transmitted by female sandflies. Visceral leishmaniasis causes fever, weight loss, spleen and liver enlargement, and, if not treated, death. P...eople with both visceral leishmaniasis and HIV are particularly difficult to cure.
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Cutaneous leishmaniasis 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 asso...ciated with regional conflicts.
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1 billion people are at risk of infection with leishmaniasis, a neglected disease strongly linked to poverty. There’s no single, simple cure: current treatments are complex and need to be adapted to the form of the disease and geographical region.
Accessed on 04.04.2023
The Drugs for Neglected Diseases initiative (DNDi) is an international
non-profit organization that discovers, develops, and delivers safe,
effective, and affordable treatments for the most neglected patients
The Leishmaniasis East Africa Platform (LEAP) was established to support the generation of scientific evidence for the development and distribution of new treatments for leishmaniasis in Eastern Africa.
Dieses Kurzdossier konzentriert sich besonders auf den Zusammenhang zwischen zwei übertragbaren
tropischen Armutserkrankungen – dem Wurmbefall des Darms durch Geohelminthen wie Spul-,
Peitschen- und Hakenwürmer sowie der Schistosomiasis (Bilharziose). Es zeigt Möglichkeiten zu
deren Bekämpf...ung auf und appelliert an internationale Entwicklungspartner, im Rahmen ihrer Gesundheits-
und Ernährungsprogramme regelmäßige Entwurmungsbehandlungen für alle, die eine
solche Behandlung benötigen, zugänglich zu machen. So können die Lebensbedingungen der Armen
nachhaltig verbessert werden.
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In case of resistance to rifampicin, fluoroquinolones become the preferred category of second-line drugs. Unfortunately, quinolone-resistant strains of Mycobacterium leprae have also been reported in several countries, probably due to the extensive use of quinolones for treating several types of inf...ections. Clofazimine resistance is still rare but this antimicrobial cannot be given alone
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More countries eliminate human African trypanosomiasis as a public health problem: Benin and Uganda (gambiense form) and Rwanda (rhodesiense form)
Human African trypanosomiasis (HAT), or sleeping sickness, transmitted by tsetse flies in sub-Saharan Africa, is a life-threatening disease that afflict...s poor rural populations. It is caused by trypanosome parasites of 2 subspecies: Trypanosoma brucei gambiense in West and Central Africa, and T. b. rhodesiense in East Africa.
HAT transmission can be reduced and interrupted by deploying and maintaining capacities for testing people at risk in order to detect and treat cases, and by controlling tsetse populations that are in contact with humans.
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The World Health Organization (WHO) endorses the use of population-based prevalence surveys for estimating the prevalence of trachoma. In general, the prevalence of TF in children aged 1–9 years and the prevalence of TT in adults aged ≥ 15 years are measured at the same time in any district bein...g surveyed. This was the approach of the Global Trachoma Mapping Project, which undertook baseline surveys in > 1500 districts worldwide in order to provide the data required to start interventions where needed.
The survey design recommended by WHO is a two-stage cluster random sample survey, which uses probability proportional to size sampling to select 20–30 villages, and random, systematic or quasi-random sampling to select 25–30 households in each of those villages. In most surveys, everyone aged ≥ 1 year living in selected households is examined.
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As a high-burden neglected tropical disease, soil-transmitted helminth (STH) infections remain a major problem in the world, especially among children under five years of age. Since young children are at high risk of being infected, STH infection can have a long-term negative impact on their life, i...ncluding impaired growth and development. Stunting, a form of malnutrition in young children, has been long assumed as one of the risk factors in acquiring the STH infections. However, the studies on STH infection in children under five with stunting have been lacking, resulting in poor identification of the risk. Accordingly, we collected and reviewed existing related research articles to provide an overview of STH infection in a susceptible population of stunted children under five years of age in terms of prevalence and risk factors. There were 17 studies included in this review related to infection with Ascaris lumbricoides, Trichuris trichiura, hookworm, and Strongyloides stercoralis from various countries. The prevalence of STH infection in stunted children ranged from 12.5% to 56.5%. Increased inflammatory markers and intestinal microbiota dysbiosis might have increased the intensity of STH infection in stunted children that caused impairment in the immune system. While the age from 2 to 5 years along with poor hygiene and sanitation has shown to be the most common risk factors of STH infections in stunted children; currently there are no studies that show direct results of stunting as a risk factor for STH infection. While stunting itself may affect the pathogenesis of STH infection, further research on stunting as a risk factor for STH infection is encouraged.
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Cystic echinococcosis (CE) is a well-known neglected parasitic disease. However, evidence supporting the four current treatment modalities is inadequate, and treatment options remain controversial. The aim of this work is to analyse the available data to answer clinical questions regarding medical t...reatment of CE.
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Onchocerciasis, or river blindness, is a neglected tropical disease (NTD) caused by the parasitic worm Onchocerca volvulus. It is transmitted through repeated bites by blackflies of the genus Simulium. The disease is called river blindness because the blackfly that transmits the infection lives and ...breeds near fast-flowing streams and rivers, mostly near remote rural villages. The infection can result in visual impairment and sometimes blindness. Additionally, onchocerciasis can cause skin disease, including intense itching, rashes, or nodules under the skin. Worldwide onchocerciasis is second only to trachoma as an infectious cause of blindness.
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Schistosomiasis, also known as bilharzia, is a disease caused by parasitic worms. Although the worms that cause schistosomiasis are not found in the United States, people are infected worldwide. In terms of impact this disease is second only to malaria as the most devastating parasitic disease. Sc...histosomiasis is considered one of the neglected tropical diseases (NTDs).
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Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 25, No. 12, December 2019 2183
Buruli ulcer is a neglected tropical disease caused by Myocobacterium ulcerans; it manifests as a skin lesion, nodule, or ulcer that can be extensive and disabling. To assess the global burden and the progress ...on disease control, we analyzed epidemiologic data reported by countries to the World Health Organization during 2010–2017.
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After 100 years of chemotherapy with impractical and toxic drugs, an oral cure for human African trypanosomiasis (HAT) is available: Fexinidazole. In this case, we review the history of drug discovery for HAT with special emphasis on the discovery, pre-clinical development, and operational challenge...s of the clinical trials of fexinidazole. The screening of the Drugs for Neglected Diseases initiative (DNDi) HAT-library by the Swiss TPH had singled out fexinidazole, originally developed by Hoechst (now Sanofi), as the most promising of a series of over 800 nitroimidazoles and related molecules. In cell culture, fexinidazole has an IC50 of around 1 µM against Trypanosoma brucei and is more than 100-fold less toxic to mammalian cells. In the mouse model, fexinidazole cures both the first, haemolymphatic, and the second, meningoencephalitic stage of the infection, the latter at 100 mg/kg twice daily for 5 days. In patients, the clinical trials managed by DNDi and supported by Swiss TPH mainly conducted in the Democratic Republic of the Congo demonstrated that oral fexinidazole is safe and effective for use against first- and early second-stage sleeping sickness. Based on the positive opinion issued by the European Medicines Agency in 2018, the WHO has released new interim guidelines for the treatment of HAT including fexinidazole as the new therapy for first-stage and non-severe second-stage sleeping sickness caused by Trypanosoma brucei gambiense (gHAT). This greatly facilitates the diagnosis and treatment algorithm for gHAT, increasing the attainable coverage and paving the way towards the envisaged goal of zero transmission by 2030.
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GUIDE PRATIQUE À L’INTENTION DES PROGRAMMES DE LUTTE CONTRE LES MALADIES TROPICALES NÉGLIGÉES
This toolkit provides step-by-step guidance to NTD programme managers and partners on how to engage and work collaboratively with the WASH community to improve delivery of water, sanitation and hygien...e services to underserved population affected by many neglected tropical diseases. The toolkit is based on real-life programme experience, which users can match to their needs and local context. It includes a series of tools to help build multisectoral partnerships, mobilize resources, and design, implement and evaluate interventions.
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The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
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