A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever.

BACKGROUND: Only one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago-the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence. METHODOLOGY: We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology. RESULTS: A consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols. CONCLUSIONS: This project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level.

Phenotypic profile and antibiogram of biofilm-producing bacteria isolates from diabetic foot ulcers in Zaria, Nigeria.

BACKGROUND: Diabetic foot ulcers (DFUs) present with high morbidity and reduce patient's quality of life. There is a gross paucity of data on biofilm-producing bacteria in DFU Infection in North-Western Nigeria. The study sought to determine the biofilm-forming ability of bacteria isolates from DFUs and determine their antimicrobial susceptibility pattern in Zaria, North-Western Nigeria. MATERIALS AND METHODS: This hospital-based cross-sectional study of patients with DFUs was conducted from June 2018 to February 2020. Consecutive biopsies were aseptically collected. Bacteria were isolated and identified using a Microgen kit. Biofilm forming ability and antibiogram of isolates were determined using microtitre plate and disk diffusion methods, respectively. RESULTS: Of the 225 participants enrolled, males constituted the majority, 144 (64.0%) with 88 (36.0%) females, the median age of participants was 54 (48-60) years, and the age range was 36-77 years. A total of 172 bacteria were isolated, and 123 (71.5%) were biofilm producers. Staphylococcus aureus (26.7%) was the highest biofilm producer, while Citrobacter freundii and Stenotrophomonas maltophilia were the least biofilm producers, 1 (0.6%) each. A disproportionate resistance pattern was demonstrated among the biofilm and non-biofilm producers against the cephalosporins tested, ceftazidime (68% vs. 18%), ceftriaxone (50% vs. 8.0%) and cefotaxime (21% vs. 0.0%). About 46% and 68% of the biofilm producers were resistant to gentamycin and ciprofloxacin, respectively. While only 2% of the non-biofilm producers were resistant to imipenem, 11% of the biofilm producers were resistant to it. CONCLUSION: These findings revealed a high proportion of biofilm-producing bacteria and were more resistant than non-biofilm producers.

Predictors of intestinal parasite infection among HIV patients on antiretroviral therapy in Jos, Plateau State, Nigeria, 2016: a cross-sectional survey.

INTRODUCTION: intestinal parasitic infection has been reported as a cause of morbidity and mortality among HIV patients on antiretroviral therapy (ART) due to interruption in treatment of the defaulting HIV patients. This study aimed to determine the prevalence and possible causes of intestinal parasites among HIV patients on ART. METHODS: a survey involving 375 adult HIV/AIDS patients selected using a systematic random sampling technique was conducted in a Jos University Teaching hospital, Plateau State, Nigeria. Socio-demographic and clinical data was collected using semi-structured interviewer administered questionnaire and electronic dataset review. Fresh stool samples were collected from all participants for laboratory identification of intestinal parasites using formol-ether sedimentation and modified Ziehl-Neelsen techniques. Descriptive statistics, odds ratio and logistic regression model were computed at P ≤ 0.05. RESULTS: the mean age of the study participants was 41.6±9.3years. Majority 294 (78.4%) were females, 141 (37.6%) lived in the rural area, 50 (13.3%) respondents did not have toilets in their homes. Most 275 (73.3%) had ART adherence level of 95% and above. Prevalence of intestinal parasites was 28.5%. Females (aOR = 2.14, 95% CI=1.12 - 3.89) and participants with no toilet facilities (aOR = 2.0, 95% CI=1.03 - 3.94) were significantly more likely to have intestinal parasites. CONCLUSION: the prevalence of intestinal parasites was high among HIV patients. Gender and unavailability of toilet in homes were found to be predictors of having parasites. We recommend that HIV patients should be periodically screened for IPs during the follow-up clinic visits.

A systematic review on the prevalence of extended-spectrum beta lactamase-producing Gram-negative bacteria in Nigeria.

OBJECTIVE: There are numerous reported cases of extended-spectrum beta-lactamases (ESBLs) producing Enterobacteriaceae in Nigeria. Yet, there are regions in Nigeria where cases of ESBL were under-reported. The review aims to assess the prevalence of ESBL-producing Gram-negative bacteria in Nigeria and the genes involved. METHODS: An extensive literature search was carried out through an electronic database including PubMed, Scopus, Google Scholar and African Journals Online (AJOL). Articles published between January 2004 and November 2019 were included in the study. The titles and abstracts of the retrieved articles were reviewed, and then the full texts of the selected articles were reviewed. Articles were divided according to geopolitical zones. RESULTS: Among the 217 articles identified, 60 studies (10 from north-central, 4 from northeast, 7 from the northwest, 17 from the southeast, 10 from south-south, and 12 from southwest Nigeria) were included. The highest prevalence recorded was 82.3%, while the lowest was 7.5%. The genes TEM, SHV, and CTX-M were the predominant variant commonly found. The most frequently used phenotypic detection method is the double disc synergy test (DDST). CONCLUSION: ESBL-producing Gram-negative bacteria in hospital and community settings in Nigeria were commonly found. The prevalence of ESBL is very high, with one of the geopolitical zones under-reported. Future research should be conducted in these zones where there are scant studies, and a holistic approach involving the clinicians, researchers, laboratory scientists, and patients will go a long way in reducing the dissemination of this resistance mechanism.

Research as a pillar of Lassa fever emergency response: lessons from Nigeria.

Emerging and re-emerging infectious diseases are becoming more frequent and developing countries are especially at increased risk. A recurring infectious disease outbreak in Nigeria has been that of Lassa fever (LF), a disease that is endemic in Nigeria and other West African countries. Nigeria, between 1st January and 27th October 2019, reported 743 confirmed cases of LF and 157 deaths in confirmed cases. Lassa fever outbreaks continue to be recurrent after fifty years of its identification. The true burden of the disease in Nigeria is unknown while gaps in knowledge about the infection still persist. Based on the Nigeria national Lassa fever research agenda and the World Health Organisation's roadmap initiative for accelerating research and product development which enables effective and timely emergency response to LF disease epidemics among other infectious diseases; a research pillar was added to the seven existing LF emergency operations centre response pillars in 2019. We describe lessons learnt from the integration of a research pillar into the LF national emergency response.

Antimicrobial prescription pattern in a tertiary hospital

Background: Antimicrobials are nonreplaceable in the treatment of bacterial infections and thus should be used judiciously. In Nigeria, there is currently no restriction on the prescription and sale of antimicrobials. This study was conducted to assess the antimicrobial prescription pattern of physicians at a tertiary hospital in Northwestern Nigeria. Materials and Methods: A point prevalence survey was carried out among all inpatients at Ahmadu Bello University Teaching Hospital in June 2015. Those receiving an antimicrobial agent during the survey period were included in the study while patients admitted on the day of the survey were excluded from the study. Data were obtained using a structured interviewer­administered questionnaire and abstraction from patient records. Information obtained included demographic data, antimicrobial agents prescribed, indication for treatment, laboratory data, and stop/review dates of prescriptions. Data were analyzed using SPSS version 20.0. Results: Twenty­three wards with a total number of 318 inpatients were enlisted. Of these, 210 (66%) patients were on treatment with antimicrobials. Male: female ratio of patients on antimicrobials was 1.2:1, and age of respondents ranged from 1 day (0.0027 years) to 75 years. The overall antimicrobial prevalence rate was 210 (66%) with surgical prophylaxis 100 (47.6%) as the most common indication. Overall, 332 antimicrobials were prescribed with cephalosporins as the most common class prescribed 96 (28.9%). Majority of the prescriptions (328, 98.8%) were based on empirical treatment, 288 (86.7%) were open prescriptions, and only 4 (1.2%) were according to treatment guidelines. Conclusion: The high prevalence of antimicrobial use highlights the need for an antimicrobial stewardship program in this facility

Pattern of prevalent Hepatitis B virus genotypes in Zaria, Nigeria.

BACKGROUND: Hepatitis B virus (HBV) is hyperendemic in Nigeria. Available literature reveal genotype E as being predominant in West Africa. This study aimed at identifying the current pattern and prevalent genotypes of HBV in Zaria, Nigeria. MATERIALS AND METHODS: Four millilitre of blood was collected in ethylenediaminetetraacetic acid-container from each of 165 HBV surface antigen-positive participants recruited purposively from the gastroenterology clinic from May to August, 2017. Plasma was separated and frozen at -20°C till analysis. Multiplex-nested polymerase chain reaction using type-specific primers was used to identify the various HBV genotypes. RESULTS: Median (and interquartile range) age of the participants was 31.0 (25.5-39.0) years, with males constituting 107 (64.8%). Majority (83.6%) of the samples analysed were HBV-DNA-positive with 82.6% of the HBV-DNA-positive samples being mixed genotype infections. Irrespective of mode of occurrence, five HBV genotypes were identified with HBV/E (97.1%) being the most predominant, followed by HBV/B (82.6%), HBV/A (24.6%), then HBV/C (17.4%), while HBV/D (0.7%) was the least prevalent. CONCLUSION: In most (99.1%) of the mixed-infection were a combination of genotype E, the predominant genotype, with other genotypes predominantly genotype B. HBV genotypes E, B, A, C and D are the prevalent genotypes in Zaria, Nigeria, as they occur in single genotype and in mixed-genotypes pattern.

The risk factors of exposure to rubella among pregnant women in Zaria 2013.

INTRODUCTION: rubella virus usually causes a mild disease, but maternal infection early in pregnancy often leads to birth defects known as congenital rubella syndrome (CRS). Rubella remains poorly controlled in Africa despite being a vaccine preventable disease. The objective of this study was to determine the risk factor of expose of rubella and prevalence of rubella IgG antibodies among pregnant women in Zaria. The results of this study will provide data which may be used to advise the government of Kaduna State on the need to include rubella vaccine in the free routine immunization particularly for women of childbearing age. METHODS: a cross-sectional study was carried out. Pregnant women attending antenatal clinics from three different health facilities in Zaria. A questionnaire was administered, to determine the proportion of pregnant women vaccinated and the sera of these women were tested for rubella IgG antibody using commercially produced enzyme-linked immunosorbent assay (ELISA) Kit. Statistical variables were compared with univariate (frequencies) bivariate (chi- square), multivariate analyses (logistic regression). A p-value of < 0.05 was considered significantly associated at 95% confidence intervals. RESULTS: of the 246 pregnant women screened, 222 (90.2%) were positive for rubella IgG. Prevalence was highest 82/222 (36.9%) among age group 20-24 years. Those positive of those who had completed secondary school education were 104/222 (46.8%) A large number among those who tested positive with 197/222 (88.7%) were married. The Hausa tribe 155/222 (69.9%) had the highest positivity for rubella IgG. Only 2 (0.9%) women claimed to have received rubella vaccine and 159/222 (71.6%) women were seropositive for IgG among the unemployed group. CONCLUSION: the serological evidence of rubella virus is an indication that rubella is endemic in Nigeria. Nigeria should include rubella vaccination in the routine immunization exercise for women before they get pregnant to reduce the risk of CRS.

Predictors of insecticidal net use among internally displaced persons aged 6-59 months in Abuja, Nigeria.

INTRODUCTION: Malaria is the commonest cause of morbidity and mortality among displaced populations especially children in endemic countries. Nigeria, an endemic country, has had increase in internally displaced persons (IDP) due to insurgency. utilization of long-lasting insecticidal nets (LLIN) is a key strategy employed to achieve global targets of malaria elimination and its effectiveness is determined by utilization, coverage and maintenance. We determined the coverage and utilization of LLIN among children aged 6-59 months at IDP camps and its predictors. METHODS: A cross-sectional study was conducted among children aged 6-59 months at the three IDP camps in Abuja. We collected data on socio-demographic characteristics, LLIN ownership and utilization using computer-aided interview, complemented by direct observation of nets. We defined universal LLIN coverage as the proportion of households with one LLIN to two persons and utilization as an eligible child sleeping under the LLIN the night preceeding the survey. Bivariate analysis was done at p < 0.25 and logistic regression at 5% level of significance. RESULTS: Overall, 393 children were enrolled with mean age of 33.3 ± 17.4 months, 51.6% were female. Household LLIN ownership was 76.7.5%, universal coverage 11.2% and utilization 89.7%. Independent predictors of LLIN utilization were LLIN hung at sleeping area (adjusted OR: 99.9, CI: 22.7 - 438.8) and type of camp site (adjusted OR: 8.2, CI: 2.5 - 27.4). CONCLUSION: LLIN utilization was high in these IDP camps despite low coverage. LLIN distribution and hanging campaigns are recommended to reduce malaria transmission in the IDP camps.

Innovative Technological Approach to Ebola Virus Disease Outbreak Response in Nigeria Using the Open Data Kit and Form Hub Technology.

The recent outbreak of Ebola Virus Disease (EVD) in West Africa has ravaged many lives. Effective containment of this outbreak relies on prompt and effective coordination and communication across various interventions; early detection and response being critical to successful control. The use of information and communications technology (ICT) in active surveillance has proved to be effective but its use in Ebola outbreak response has been limited. Due to the need for timeliness in reporting and communication for early discovery of new EVD cases and promptness in response; it became imperative to empower the response team members with technologies and solutions which would enable smooth and rapid data flow. The Open Data Kit and Form Hub technology were used in combination with the Dashboard technology and ArcGIS mapping for follow up of contacts, identification of cases, case investigation and management and also for strategic planning during the response. A remarkable improvement was recorded in the reporting of daily follow-up of contacts after the deployment of the integrated real time technology. The turnaround time between identification of symptomatic contacts and evacuation to the isolation facility and also for receipt of laboratory results was reduced and informed decisions could be taken by all concerned. Accountability in contact tracing was ensured by the use of a GPS enabled device. The use of innovative technologies in the response of the EVD outbreak in Nigeria contributed significantly to the prompt control of the outbreak and containment of the disease by providing a valuable platform for early warning and guiding early actions.