ABSTRACT
Depuis décembre 2019, une maladie émergente à coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV) appelée coronavirus disease 2019 (COVID-19) s'est rapidement propagée dans le monde entier à partir de Wuhan en Chine, entrainant un nombre toujours plus élevé de cas confirmés et des décès. Malheureusement, à ce jour aucun médicament ou vaccin n'a encore été approuvé ou recommandé universellement, les thérapeutiques actuelles sont essentiellement de soutien ou compassionnelles. Plusieurs options sont envisagées ou en étude comprenant les vaccins, les antibiotiques (azithromycine), les agents antiviraux (lopinavir, ritonavir, Ribavirin, Arbidol), antiparasitaires (chloroquine, hydroxychloroquine, ivermectine), les immunomodulateurs et autres molécules du système immunitaire (Tocilizumab, interférons), les plantes de la médecine traditionnelle
Subject(s)
COVID-19 , Clinical Trial , Coronavirus Infections/diagnosis , Coronavirus Infections/therapy , Democratic Republic of the Congo , Severe Acute Respiratory Syndrome , Viral VaccinesABSTRACT
Bioprinting advances have revolutionised drug discovery and are set to disrupt biomedical research and medical application through the development of reproducible, fine-tuned functional 3D tissues and, eventually, whole organs. This intersectional bottom-up approach of additive manufacturing requires collaboration between tissue engineers, materials chemists, software and electrical engineers and medical practitioners for the software, hardware and wetware required by this disruptive technology. This review provides a current overview of the state of the art of bioprinting and the biomaterials/bioinks required, as well as the challenges and prospects for medical application in South Africa
Subject(s)
Adaptation, Physiological , Bioprinting , Clinical Trial , Health Services Accessibility , Medical Informatics Applications , South AfricaABSTRACT
Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks; a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council's (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant's identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names; SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs; the system flagged this as a potential coenrolment By addressing the ethical concerns around participant consent and rights; participant confidentiality and privacy; data security and access; and data management and storage; we were able to successfully implement BCEPS within the clinical trials conducted at HPRU; while adhering to the principles of good clinical practice (GCP); including respect for persons; beneficence and justice
Subject(s)
Biometric Identification , Clinical Trial , Computer Security , Ethics , Informed ConsentABSTRACT
HIV and AIDS is recognized as one of the most devastating pandemics of sub-Saharan Africa; and South Africa in particular; with adverse effect on individuals; families; schools; communities and society at large. Research is therefore required to provide a deeper understanding of the complexities of HIV and AIDS in order to mitigate the effect of the pandemic. Much of the excellent research that has been done has been undertaken within a positivist paradigm and has focused on the biomedical aspects of HIV and AIDS; as well as the social aspects of the pandemic. This theoretical position paper draws on various projects in the field of HIV and AIDS education in rural KwaZulu-Natal to argue that more social science research should be framed within a participatory research paradigm; foregrounding participant engagement and process; and which simultaneously has a 'research-as-intervention' focus. Such research adheres to the requirement of knowledge production; but also engages the participants as knowledge producers who; through the research process; are enabled to shift towards taking up their own agency. Reflecting on the findings from the various projects suggests that visual participatory methodologies are particularly useful when working with marginalized persons whose voices are seldom heard especially when exploring topics which are difficult to discuss. Furthermore; it brings issues to the fore and opens up debate; while at the same time democratizing research and allowing universities to take up their social responsibility and to contribute towards making a difference in the communities they serve
Subject(s)
Acquired Immunodeficiency Syndrome , Community-Based Participatory Research , Clinical Trial , Planning Techniques , Qualitative Research , Social Change , Social SciencesABSTRACT
A rumour that emerged during a microbicide gel trial tells the tale of clinic staff purchasing trial participants' blood. This paper documents the rumour and explores its divergent interpretations and meanings in relation to the context of the trial and the social and economic setting at two of the trial sites (Soweto and Orange Farm) in South Africa. The article is based on qualitative research conducted during the Microbicides Development Programme (MDP) 301 trial to evaluate a microbicide vaginal gel for HIV prevention in women. The research incorporated in-depth interviews with female trial participants and their male partners; focus group discussions with male and female community members; and participant observation in the trial clinic and community setting at the two sites. The article analyses the different perspectives among the clinic staff; community and trial participants in terms of which the rumour about the exchange of blood for cash is seen as: 1) the result of ignorance of the clinical trial procedures; 2) the exploitation of poor and vulnerable women; 3) an example of young women's desire for material gain; and 4) a reciprocal exchange of 'clean blood' for cash between women trial participants and the health services. We suggest that the rumours about selling blood verbalise notions of gender and morality while also providing an appraisal of the behaviour of young women and a critique of social relationships between foreign researchers and local participants. Through stories about the clinical trial procedures and its potential reimbursements; the participants were creating and reconfiguring social relationships. Ultimately; rumours are one way in which foreign enterprises such as a clinical trial are rendered local
Subject(s)
Anthropology , Anti-Infective Agents , Blood Specimen Collection , Clinical TrialABSTRACT
This study seeks to determine the prevalence of recovery of Escherichia coli from clinical specimens of superficial wounds; high vagina and antral washouts. This study which was prospective and cross-sectional involved six hundred and sixty eight (668) participants who were patients seen at the various facilities in the hospital. Males were two hundred and forty (35.9) Females were two hundred and twenty eight (34.3) while children were two hundred (29.9). Specimens of wounds; aspirates and high vagina were cultured on chocolate; blood and McConkey and Eosin methylene blue agars. Specimens on blood agar were incubated both aerobically and anaerobically for 24hrs. Isolates were identified by their colonial morphology and biochemical reactions and tested for sensitivity. Escherichia coli isolates demonstrated strong resistance to some of the antibiotics while they showed moderate sensitivity to ceftazidime; ofloxacin; clarithomycin and amoxicillin clavulanate. The increasing resistance of Escherichia coli to the commonly used antibiotics in the community is a cause of concern; and measures were suggested for effective resistance control
Subject(s)
Clinical Trial , Escherichia coli , Microbial Sensitivity Tests , Prevalence , Wounds and InjuriesABSTRACT
Background/rationale: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. Objectives: The major objective was to address informed consent in human research in non-Western societies; and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations; such as children; adolescents and women. Methods: A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed; using the search terms `HIV/AIDS'; `informed consent'; `clinical trials'; `developing world'. Results: Ethical complexities such as participants' diminished autonomy; coercion or monetary inducement; language difficulties; illiteracy or lack of true understanding of the entire study; cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age; while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used; while trusted community leaders and local cultural representatives may convey information. Discussion: Despite the heterogeneity of studies; similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representation. Conclusions: International investigators of HIV human research should bear in mind these ethical issues and their potential solutions; when trying to ensure ethical research conduct; based on a truly informed and culturally relevant consent
Subject(s)
HIV , Acquired Immunodeficiency Syndrome , Clinical Trial , EthicsABSTRACT
The global clinical trials industry is driven by the needs of pharmaceutical companies to bring new products to market; rapidly and in compliance with regulatory requirements. Many of the largest multinational pharmaceutical companies - the so-called 'pharmas' - are active in South Africa in importing and producing pharmaceuticals and in the conduct of clinical trials. This clinical trials industry now forms an important sub-sector of research and development (RetD) in the country. The release in August 2007 of the long-awaited Department of Trade and Industry national industrial policy framework designates four key value chains in the economy; one of which is chemicals; plastic fabrication and pharmaceuticals. This intention raises a key question: is South Africa to be a factory for the pharmas; or can it leverage its existing strengths in medical research and the conduct of clinical trials to develop a discovery-led local industry? This paper therefore offers an analytical and quantitative profile of the current state of the clinical trials industry in South Africa; to enquire as to its potential to grow a local pharmaceutical industry
Subject(s)
Clinical Trial , Drug Industry , Economics , Pharmaceutical Preparations , ResearchABSTRACT
Le sulfate de magnesium (MgSO4) previent et traite les manifestations neurologiques notamment les crises convulsives induites par les syndromes vasculo- renaux severes. L'objectif de notre etude etait d'evaluer son efficacite et sa tolerance.Nous avons mene une etude a la fois retrospective et prospective sur 30 mois a l'Hopital de la Mere et Enfant Lagune (HOMEL) de Cotonou chez 211 patientes souffrant de pre- eclampsie severe et d'eclampsie. Le sulfate de magnesium (MgSO4) etait utilisee a la dose d'attaque de 4g d'une concentration a 20par voie intra- veineuse lente (IVL) sur une duree de 15 a 20 mn associee a 10g intra- musculaire (IM) d'une concentration a 50(repartis pour 5g dans chaque muscle fessier) ; la dose d'entretien etait de 5g a 50IM (2;5g dans chaque muscle fessier) toutes les 4 heures. La surveillance des reflexes osteo- tendineux; de la frequence respiratoire et de la diurese etait assuree toutes les heures.760 cas etaient colliges sur 17.753 accouchements(4;28) dont 211cas traites par le MgSO4 ( 74 et 134 cas respectivement de pre- eclampsie severe et d'eclampsie; soit 1;27et 3;01des accouchements) ; l'age moyen des patientes etait de 24;74 ans. Les pressions arterielles systolique(PAS) et diastolique(PAD) etaient respectivement de 160 et compris entre 110- 120 mm Hg dans 91;94 et 86des cas; accompagnees notamment de crises convulsives(65) et de coma(12). L'efficacite du MgSO4 etait nette des la 24eme heure a la seule dose d'attaque avec amendement des convulsions dans 53;68des cas sans recidives. Le pronostic neonatal etait satisfaisant ; la morbidite maternelle etait amelioree et la letalite de 0;94etait tres en deca du taux (8;05) rapporte a l'HOMEL de Cotonou en 2001 avant l'utilisation du MgSO4
Subject(s)
Humans , Benin , Clinical Trial , Eclampsia , Magnesium Sulfate/therapeutic use , Pre-EclampsiaABSTRACT
La presente etude retrospective sur la valeur pronostique de la Working Formulation a propos de 60 cas colliges au CHU de Yopougon a permis de preciser que: -les LMNH de haut grade et de grade intermediaire predominent dans respectivement 56;7pour cent et 33;3pour cent ; - L'age a une influence significative sur le type histologique ; -L'existence de signes d'evolutivite cliniques et/ou biologiques n'est pas predictive du type histologique ;-La remission complete est obtenue generalement dans les lymphomes agressifs au prix d'une chimiotherapie lourde
Subject(s)
Clinical Trial , Lymphoma, Non-HodgkinABSTRACT
Acalypha wilkesiana is a common hedging plant in West Africa. Water extract of the red/brown varieties; the Red Acalypha has been used for decades by the local inhabitants for treating skin problems. The water extract of A. wilkesiana was subjected to a clinico-laboratory study to assess its efficacy i.e. ability to clear standard organisms in agar plates and to stop symptoms and clear skin lesions of eczema cases in a 3-week study period. The extract showed significant antibacterial and antifungal properties in vitro and was found to be reasonably useful in the treatment of eczema. No allergy or irritation was documented in the cases used for the study. In a depressed economy as found in most developing countries of Africa; medicinal plants like Acalypha wilkesiana could be used as a cheap and readily available sources of skin medication. More work is required to determine the active ingredients in the crude extract
Subject(s)
Anti-Bacterial Agents , Clinical Trial , Dermatitis , In Vitro Techniques , Plant ExtractsABSTRACT
L'objectif de cette etude etait d'evaluer de maniere comparative; les resultats de la therapie de rehydratation par voie orale (TRO) avec la solution standard obtenue avec les sachets de l'OMS et une solution a base de pulpe de fruit de baobab (Adansonia digitata); pain de singe; chez les enfants presentant une diarrhee aigue. Un essai clinique de TRO a ete mene chez des enfants diarrheiques; ages de 6 mois a 57 mois et presentant une diarrhee ou une deshydratation moyenne ; 79 enfants ont recu la solution OMS et 82 la solution de pain de singe ; l'evolution de la diarrhee et le gain de poids ont ete evalues. La solution OMS a eu des resultats legerement superieurs a ceux de la solution a base de pain de singe; quant a l'amelioration de la diarrhee et au gain de poids aux 4eme et 48eme heures; mais cette difference etait statistiquement non significative. La solution a base de pain de singe presente en outre des avantages sur le plan nutritif; economique et socio-culturel ; les auteurs la recommandent; en vue d'une utilisation plus etendue de la TRO a domicile
Subject(s)
Clinical Trial , Dehydration/therapy , Herbal , MedicineABSTRACT
De juin 2003 a mai 2004 nous avons mene une etude comparative de deux schemas de traitement prophylactique antipaludique au cours de la grossesse. L'objectif de l'etude etait de comparer l'efficacite de deux schemas de prevention du paludisme par chloroquine (CQ) ou de sulfadoxine-pyrimethamine (SP) au cours de la grossesse et a l'accouchement dans un village d'endemie palustre du Mali; Faladie aux deuxieme et troisieme trimestres de la grossesse en evitant le 9e mois pour la SP. Nous avons effectue un essai clinique randomise comparatif ouvert de deux groupes de gestantes volontaires soumises a l'un ou a l'autre traitement. Un tirage au sort sans remise a ete fait pour repartir les gestantes de facon equitable entre les deux groupes de traitement. L'etude a etemenee dans le village de Faladie (cercle deKati) situe a 80 km de Bamako. Elle a porte sur 301 femmes dont 150 pour le groupe CQ et 151 pour le groupe SP.A l'inclusion; les deux groupes etaient comparables quel que soit le parametre de jugement socio-demographique et paludometrique utilise.A l'accouchement; l'infection palustre a ete reduite de 43;3(p : 10-6) dans le groupe CQ et de 79;1dans le groupe SP (p : 10-6). Le taux d'anemie a baisse de 57;5chez les femmes soumises a la CQ (Chi2 de McNemar = 0;017) et de 74;8chez celles ayant recu la SP (Ch2 de McNemar = 0;025). L'infection placentaire etait de 20;6dans le groupe CQ contre 8;3dans le groupe SP (p=4.10-3). Au total; 16;7des nouveau-nes avaient un faible poids a la naissance parmi lesquels 70;4etaient issus du groupe CQ. Le traitement intermittent presomptif par la SP protege donc plus efficacement la mere et l'enfant contre le paludisme gestationnel et ses conse- quences nefastes que le traitement intermittent par la CQ