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NCT ID: NCT03353051 Recruiting - Neonatal Infection Clinical Trials

Iron and Infection: Neonatal Nutritional Immunity

NeoInnate
Start date: July 25, 2017
Phase: N/A
Study type: Observational

The motivation for this study was produced from our preliminary data, which showed that during the first 96 hours of life a full-term neonate will actively reduce the overall serum iron concentration of their blood and the transferrin saturation decreases rapidly from 45% in cord blood to ~20% by six hours post-delivery. The Investigators hypothesise that this active sequestration of iron, which results in hypoferremia, is done in an effort to limit susceptibility to infection, a process referred to as nutritional immunity. Currently, little is known about iron regulation and iron homeostasis during the first week of life and even less is known about the comparisons of nutritional immunity between full term, preterm and low birth weight neonates. Additionally, limited research has been conducted on the impact of these processes on bacterial pathogens. In an effort to study the neonatal nutritional immunity and its role in neonatal susceptibility to infection, The investigator will conduct an observational study in full-term, preterm and low birth weight vaginally-delivered neonates born at Serrekunda General Hospital, The Gambia. The investigators will fully characterise and quantify nutritional immunity during the early neonatal period and the investogators will assess how this impacts bacterial growth. Study sensitisation will occur at the antenatal clinic, during the mother's second trimester of pregnancy. Mothers will be consented and enrolled at delivery. Blood samples will be collected once from the umbilical cord and at serial time points from the neonates over the first week of life.

NCT ID: NCT03350048 Recruiting - Clinical trials for Pulmonary Tuberculosis

Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB

ScreenTB
Start date: May 2, 2016
Phase: N/A
Study type: Observational

Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world. Despite the introduction of the highly sensitive and specific GeneXpert MTB/RIF (GeneXpert) test [1] with a potential turn-around time of two hours, many people in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical constraints in these settings. A cost effective, rapid, point-of-care screening test with high sensitivity would identify people with a high likelihood for active TB and would prioritize them for testing with more expensive, technically or logistically demanding assays including GeneXpert or liquid culture, facilitating cost-effective diagnostic work-up in resource-limited settings. A serum cytokine signature for active TB disease, discovered in the AE-TBC project, with a sensitivity of 89% (CI 78 - 95%) and specificity of 76% (CI 68 - 83%), will be optimised and utilized in a point-of-care format (TransDot) to rapidly test for TB disease in symptomatic people. Hypothesis: The TransDot test will achieve a sensitivity of > 90% for TB disease, in a training set of people suspected of having TB disease, and be validated (achieve similarly high sensitivity) subsequently in a prospective test set of people suspected of having TB disease, when compared to a composite gold standard of sputum culture, smear, GeneXpert, chest X-ray, TB symptoms and TB treatment response. Objectives: The overall objective of the study is to incorporate a six-marker serum signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot test on finger-prick blood for active TB and will be prospectively compared against gold standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB symptom screen and response to TB treatment). Primary: The primary outcome of interest will be accuracy, sensitivity and specificity of the TransDot finger-prick test when compared with the composite gold standard tests.

NCT ID: NCT03341338 Recruiting - Anemia Clinical Trials

Genes-in-Action - Hepcidin Regulation of Iron Supplementation

Start date: September 5, 2016
Phase: N/A
Study type: Observational

Anaemia continues to be one of the most common health problems affecting children and pregnant women in low-income countries. Nutritional iron deficiency is believed to be the main driver of anaemia, so mass iron supplementation and food fortification programs have been recommended by most public health organizations. However, these interventions are frequently ineffective and new strategies are desperately needed. Both anaemia and iron absorption are influenced by multiple factors, including nutritional status, infection, low grade inflammation and host genetics. The discovery of hepcidin, the master regulator of iron absorption and regulation has opened new avenues for investigation. Genome-wide association studies have identified several single nucleotide polymorphisms (SNPs) within hepcidin regulatory genes that are associated with altered iron status both in African populations. The study aims to investigate the impact of genetic alterations in hepcidin regulation on oral iron absorption. A recall-by-genotype study will be conducted using an existing database of pre-genotype individuals in rural Gambia (West Kiang). This database comprise of data on >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative functional variants as well as imputation data on 20M variants.

NCT ID: NCT03246230 Recruiting - Clinical trials for Newborn Vaccine Immunogenicity

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

EPIC-HIPC
Start date: September 6, 2017
Phase: N/A
Study type: Interventional

Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use. To gain insight into how vaccines induce protection of the most vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy & Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV): (a) systems biology that uses technologies which comprehensively measure global changes in molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell composition of the blood and (b) use of human newborn blood components, collected prior to immunization, to model vaccine responses in vitro (outside the body). Characterizing vaccine-induced molecular patterns ("signatures") that correspond to vaccine-mediated protection will accelerate development and optimization of vaccines against early life infections of major global health importance.

NCT ID: NCT03199547 Recruiting - Neonatal SEPSIS Clinical Trials

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

PregnAnZI-2
Start date: October 21, 2017
Phase: Phase 3
Study type: Interventional

Though maternal and neonatal health are high priority areas for international development, maternal and neonatal mortality remain unacceptably high. Worldwide there are 1 million maternal and 4 million neonatal deaths every year and half of them occur in sub-Saharan Africa. Post-partum and neonatal severe bacterial infections, namely sepsis, are leading causes of maternal and neonatal deaths in sub-Saharan Africa. Newborns can be infected during labour - when passing through the birth canal - and also during the first days/weeks of life, as a consequence of the close physical contact with the mother, when the latter carriers bacteria. As the mother is an important source of bacterial transmission to the newborn, treating mothers with antibiotics during labour should decrease their bacterial carriage and therefore lower transmission to the newborn. As carriage is a necessary step towards severe disease, this intervention should in turn result in the lower occurrence of severe bacterial disease and mortality during the neonatal period. In many high-income countries, pregnant women are screened during pregnancy for vaginal carriage of Group B Streptococcus, the bacteria responsible for the vast majority of neonatal sepsis in the developed world. If women are carriers, they are treated with intravenous antibiotics during labour to decrease the risk of severe disease to their off-spring. Although this intervention has been successful in developed countries, infrastructure and resource limitations in regions like sub-Saharan Africa prevent both screening and use of intravenous antibiotics. Also, in Africa several bacterial pathogens are responsible for neonatal sepsis and the antibiotics needed in the continent should cover a wider number of bacteria; and ideally cover also bacteria responsible for severe post-partum disease in the mother. We will conduct a large trial in West Africa, The Gambia and Burkina Faso, with the main objective of determining if a single dose of an oral antibiotic given to women during labour decreases newborn mortality. The trial will also assess the effect of the antibiotic on lowering newborns and maternal hospitalization during the first week's post-partum. We have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already been used for elimination of other prevalent diseases such as trachoma. This antibiotic is safe, requires a single oral administration, has no special storage requirements and has the potential to eliminate most of the bacteria commonly causing severe disease in newborns and post-partum women in the continent. Very important this antibiotic is not widely used in clinical care in the continent, and therefore, any temporal increase of resistance induced by the intervention should not have implications on current treatment guidelines. Before going to the large trial proposed here (12,500 women to be recruited), we have generated robust preliminary data on the effect of the intervention in a proof-of-concept trial conducted in The Gambia (829 women and their offspring recruited). We found that in fact, babies born from mothers who had taken this antibiotic during labour were less likely to carry bacteria that can potentially cause severe disease. These babies were also three times less likely to have bacterial skin infections or umbilical infections, both highly common among African newborns. Besides, fever or mastitis (again both very common in the region) during the post-partum period were four times lower among mothers who had taken the antibiotic during labour. Such trial confirmed our hypothesis of impact on bacterial transmission but it was too small to assess the effect of the antibiotic on mortality and hospitalizations. The preliminary trial also showed that women from the azithromycin group were less likely to need antibiotics for treatment infections during the puerperal period, decreasing then the pressure on the scarcity of antibiotics available in the continent. The advantages of our approach are its simplicity, low cost and the possibility of protecting both mothers and babies with the same intervention.

NCT ID: NCT03197376 Recruiting - Clinical trials for Pneumonia, Pneumococcal

Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants

Start date: June 21, 2017
Phase: Phase 3
Study type: Interventional

This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT02972957 Not yet recruiting - Influenza Clinical Trials

A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia

NASIMMUNE
Start date: January 2017
Phase: Phase 4
Study type: Interventional

The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given into the nose and in early studies was shown to be better than the standard influenza vaccine at preventing infections in children. However, more recently, it has performed less well and it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why this is, but the investigators also do not fully understand why LAIV produces stronger nasal antibody responses in some individuals but not others. Usually harmless bacteria that are present in participants noses can influence how our immune system works and variations in these may explain differences in how LAIV works. The project will recruit children given LAIV in the Gambia to gain further understanding of these issues. The investigators will measure a variety of responses to LAIV, including genes that can change their expression early after vaccination and use advanced computational techniques to identify new relationships between these genes and other LAIV responses. The investigators will also see whether nasal bacterial profiles in children who respond to LAIV are different from those who do not. In addition, the investigators will alter these bacteria in a subset of children with antibiotics and see whether this affects both nasal gene expression and later responses to LAIV.

NCT ID: NCT02967783 Active, not recruiting - Poliomyelitis Clinical Trials

A Campaign-based ID fIPV Administration Trial

Start date: February 7, 2017
Phase: N/A
Study type: Interventional

The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine immunization schedules in OPV-only using countries as part of the Global Polio Eradication Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in the global IPV supply landscape, the GPEI polio eradication program is facing a critical shortage of the vaccine which is forecast to continue until at least the end of 2017. The shortage means that some countries that have already introduced the vaccine, but which are considered to be relatively low risk (The Gambia included), will be left without adequate supplies and in other countries IPV introduction is being unavoidably delayed. Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR). The current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a large scale IPV campaign will be implemented to increase population immunity to the type 2 poliovirus in an large area surrounding the outbreak as high risk of extending transmission. Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning purposes, there is an urgent need to assess the practical and logistic challenges a country such as The Gambia would face in rapidly undertaking an ID fIPV campaign.

NCT ID: NCT02941081 Not yet recruiting - Clinical trials for Iron Deficiency, Anaemia in Children

A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial

IHAT-Gut
Start date: October 2017
Phase: Phase 2
Study type: Interventional

This study aims to determine whether IHAT is non-inferior to ferrous sulphate at correcting iron deficiency and anaemia, and if IHAT does not increase diarrhoea risk in young children living in rural and resource-poor areas of the Gambia. The study hypothesis is that IHAT will eliminate iron deficiency and improve haemoglobin levels in young children without increasing infectious diarrhoea or promoting inflammation in the gut.