In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.
View Article and Find Full Text PDFGlobal health requires evidence-based approaches to improve health and decrease inequalities. In a roundtable discussion between health practitioners, funders, academics and policy-makers, we recognised key areas for improvement to deliver better-informed, sustainable and equitable global health practices. These focus on considering information-sharing mechanisms and developing evidence-based frameworks that take an adaptive function-based approach, grounded in the ability to perform and respond to prioritised needs.
View Article and Find Full Text PDFThe COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research.
View Article and Find Full Text PDFAs healthcare authorities around the world strive to get as many citizens as possible vaccinated against the SAR-CoV-2 virus, many countries have begun including children in the population groups to be vaccinated. Properly designed clinical trials involving children are important to ensure safety, efficacy, and dosage of therapies in (developing) children. Within the complex health, social, and political scenario of the ongoing pandemic, ethics committees and policy makers in low-income and middle-income settings need to consider additional ethical questions when called on to review phase III COVID-19 vaccine trials involving in children.
View Article and Find Full Text PDFBackground: Malaria remains a public health burden especially in Nigeria. To develop new malaria control and elimination strategies or refine existing ones, understanding parasite population diversity and transmission patterns is crucial.
Methods: In this study, characterization of the parasite diversity and structure of Plasmodium falciparum isolates from 633 dried blood spot samples in Nigeria was carried out using 12 microsatellite loci of P.
Malaria disproportionately affects all ages with a high burden among children below five years. Thus, control measures are deployed including Seasonal Malaria Chemoprevention (SMC). The present study assessed the impacts of SMC on malaria burden among subjects aged 3-59 months in Borno State, Nigeria.
View Article and Find Full Text PDFCOVID-19, caused by a novel coronavirus named SARS-CoV-2, was identified in December 2019, in Wuhan, China. It was first confirmed in sub-Saharan Africa in Nigeria on 27 February 2020 and has since spread quickly to all sub-Saharan African countries, causing more than 111,309 confirmed cases and 2,498 deaths as of 03 June 2020. The lessons learned during the recent Ebola virus disease (EVD) outbreaks in some sub-Saharan African countries were expected to shape and influence the region's responses to COVID-19 pandemic.
View Article and Find Full Text PDFIn non-anaemic children with malaria, early-appearing anaemia (EAA) is common following artemisinin-based combination treatments (ACTs) and it may become persistent (PEAA). The factors contributing to and kinetics of resolution of the deficit in haematocrit from baseline (DIHFB) characteristic of ACTs-related PEAA were evaluated in 540 consecutive children with malaria treated with artemether-lumefantrine, artesunate-amodiaquine or dihydroartemisinin-piperaquine. Asymptomatic PEAA occurred in 62 children.
View Article and Find Full Text PDFBackground: The development and spread of artemisinin-resistant Plasmodium falciparum malaria in Greater Mekong Subregion has created impetus for continuing global monitoring of efficacy of artemisinin-based combination therapies (ACTs). This post analyses is aimed to evaluate changes in early treatment response markers 10 years after the adoption of ACTs as first-line treatments of uncomplicated falciparum malaria in Nigeria.
Methods: At 14 sentinel sites in six geographical areas of Nigeria, we evaluated treatment responses in 1341 children under 5 years and in additional 360 children under 16 years with uncomplicated malaria enrolled in randomized trials of artemether-lumefantrine versus artesunate-amodiaquine at 5-year interval in 2009-2010 and 2014-2015 and at 2-year interval in 2009-2010 and 2012-2015, respectively after deployment in 2005.
Background: In acute falciparum malaria, asexual parasite reduction ratio two days post-treatment initiation (PRRD2) ≥ 10 000 per cycle has been used as a measure of the rapid clearance of parasitaemia and efficacy of artemisinin derivatives. However, there is little evaluation of alternative measures; for example, parasite reduction ratio one day after treatment initiation (PRRD1) and its relationship with parasite clearance time (PCT) or PRRD2. This study evaluated the use of PRRD1 as a measure of responsiveness to antimalarial drugs.
View Article and Find Full Text PDFThe efficacies of 3-day regimens of artemether-lumefantrine (AL), artesunate-amodiaquine (AA), and dihydroartemisinin-piperaquine (DHP) were evaluated in 910 children < 5 years old with uncomplicated malaria from six geographical areas of Nigeria. Parasite positivity 1 day and Kaplan-Meier estimated risk of persistent parasitemia 3 days after therapy initiation were both significantly higher, and geometric mean parasite reduction ratio 1 day after treatment initiation (PRRD1) was significantly lower in AL-treated children than in AA- and DHP-treated children. No history of fever, temperature > 38°C, enrollment parasitemia > 75,000 μL, and PRRD1 < 5,000 independently predicted persistent parasitemia 1 day after treatment initiation.
View Article and Find Full Text PDFBackground: Artemisinin-based combination therapies (ACTs) have remained efficacious treatments of acute falciparum malaria in many endemic areas but there is little evaluation of factors contributing to the anaemia of acute falciparum malaria following long term adoption of ACTs as first-line antimalarials in African children.
Methods: Malarious <5 year-olds randomized to artemether-lumefantrine, artesunate-amodiaquine or dihydroartemisinin-piperaquine treatments were followed up clinically for 6 weeks. Anaemia was defined as haematocrit <30%; Malaria-attributable fall in haematocrit (MAFH) as the difference between haematocrit 28-42 days post- and pre-treatment; Total MAFH (TMAFH) as the difference between days 28-42 haematocrit and the lowest haematocrit recorded in the first week post-treatment initiation; Drug-attributable fall in haematocrit (DAFH) as the difference between MAFH and TMAFH; Early appearing anaemia (EAA) as haematocrit <30% occurring within 1 week in children with normal haematocrit pre-treatment.
Aims And Objectives: The aim and objective of the study was to determine the incidence, bacterial isolates and the antibiogram sensitivity of the isolates in neonates with septicaemia.
Patients And Methods: The neonates with clinical diagnosis of neonatal septicaemia (NNS) were consecutively enrolled into our special care baby unit. The patients were investigated including blood cultures, cerebrospinal fluid cultures and urine among others.
Ebola virus is categorized as one of the most dangerous pathogens in the world. Although there is no known cure for Ebola virus, there is some evidence that the severity of the disease can be curtailed using plasma from survivors. Although there is a general consensus on the importance of research, methodological and ethical challenges for conducting research in an emergency situation have been identified.
View Article and Find Full Text PDFBackground: Maternal measles antibodies (MMA) are actively transferred through the placenta from mother to foetus. A relationship could exist between MMA of mother-infant pairs and maternal nutritional indicator (haemoglobin).
Objectives: This study reviewed the effects of maternal haemoglobin (Hb) on MMA of mother-infant pairs at birth.
West Afr J Med
December 2014
Background: Burkitt's lymphoma (BL) is one of the leading childhood cancers in tropical Africa. Despite this, after extensive literature search most literature reviews on BL found were old. Therefore, it is useful to learn the trend in the epidemiology of BL in north eastern Nigeria especially now that changing ecology of the disease are being published.
View Article and Find Full Text PDFBackground: Patients with sickle cell disease have increased tendency to develop frequent and severe infections, especially of bones and urinary tract.
Objective: The knowledge of antimicrobial sensitivity pattern of common etiological agents will serve as a guide to empiric treatment while results of urine culture and sensitivity are being awaited.
Materials And Methods: Antimicrobial sensitivity test was carried out on bacterial isolates from the urine of febrile children with sickle cell anemia (SCA) and children with HbAA in Maiduguri.
Background: Sickle cell disease (SCD) is a more common and severe disease in Africa. Nigeria the most populous black nation in Africa has the largest number of sickle cell anaemia (SCA) patients in the world. Borno and Yobe State has the largest number of sickle cell trait in Nigeria with prevalence of 27.
View Article and Find Full Text PDFBackground: Sickle cell anaemia (SCA) is very common in Maiduguri, North-Eastern Nigeria. Children with this disease have increased tendency to develop frequent and severe infections especially of the urinary tract, bones and lungs. The prevalence of urinary tract infection (UTI) has however not been reported in this part of the Nigeria.
View Article and Find Full Text PDFThe milestone in polio eradication program is to protect effectively children aged 0-5 years against the three serotypes of poliovirus. It became necessary to measure the level of neutralizing antibodies to the three poliovirus types in an endemic State in Nigeria. Neutralizing antibodies to the poliovirus types among children aged 0-5 years was estimated using micro neutralization assay.
View Article and Find Full Text PDFBACKGROUND: Urinary tract infection is a significant cause of morbidity in children with sickle cell anaemia (SCA). Individuals with SCA have increased risk of urinary tract infection (UTI). Facilities for urine culture may not be available in most rural and even some urban areas in most developing countries like Nigeria.
View Article and Find Full Text PDFBackground: Several types of congenital malformations have been seen in our settings, but the frequencies and pattern are not known.
Objectives: To review the prevalence and pattern of congenital malformation in the Special Care Baby Unit (SCBU) of the University of Maiduguri Teaching Hospital, Maiduguri, over a 10-year period.
Methods: This was a retrospective study carried out in a semi-urban Nigerian Teaching Hospital.
Niger J Clin Pract
December 2007
Background: Bacterial infections are important causes of morbidity in the neonatal period. Therefore identification of infecting organisms and the risk factors for possible bacterial infection in the newborn is of great importance. Institution early appropriate therapy is an important step in combating morbidity and mortality in this age group.
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