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NCT ID: NCT03199547 Not yet recruiting - Neonatal SEPSIS Clinical Trials

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

PregnAnZI-2
Start date: August 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.

NCT ID: NCT02878200 Recruiting - Malaria Clinical Trials

RHOST-cRCT, Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission

RHOST
Start date: November 2016
Phase: N/A
Study type: Interventional

Reactive treatment of household contacts of a confirmed malaria case has been shown to reduce infection prevalence since the former as they are at an increased risk of infection. However, implementing this on a programmatic scale poses significant pressure on the health system and may not be sustainable without the active involvement of the recipient community. This study investigates a novel approach to reducing residual malaria transmission that combines the elements of active community involvement in reactive treatment of household contacts of a clinical case reporting at a health facility. The investigators hypothesize that in areas of low transmission (prevalence of infection ≤10%), most asymptomatic carriers are clustered around clinical malaria cases in the same households. Also, targeting individuals sharing a sleeping area with diagnosed malaria case will reduce parasite carriage in the community. This is a cluster-randomized trial where villages in Central and Upper Baddibu, North Bank East Region of The Gambia, are randomized to receive either reactive treatment of household contacts following a confirmed case of malaria or standard care, i.e. treatment of index case only. Formative research into community perception and reaction to self-administered treatment will be used to generate, adapt and evaluate messages that encourage adherence and compliance to treatment. This will be tested in the first year of the implementation, and findings used to develop a final model of messages to be implemented in the second year of the study. The primary outcome is the prevalence of malaria infection, determined by molecular methods, in all age groups at the end of the second intervention year and the incidence of clinical malaria during the transmission season.

NCT ID: NCT02672228 Completed - Malaria Clinical Trials

Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense)

MalariaSense
Start date: October 2015
Phase: N/A
Study type: Interventional

This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble technology (MalariSense) for malaria diagnostics. The MalariSense technology will use a highly innovative approach based on the transdermal non-invasive detection of vapor nanobubbles produced by the excitation of malaria-specific hemozoin by safe, low-energy laser pulse. The objectives of this study will be to determine the sensitivity and specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia and to identify factors influencing the diagnostic accuracy of MalariSense

NCT ID: NCT02668133 Recruiting - Clinical trials for Individuals at Risk of Zinc Deficiency

Zinc Absorption From SQ-LNS With and Without Phytase

Start date: April 18, 2017
Phase: N/A
Study type: Interventional

Background: Community based-intervention trials conducted among infants and young children in low- and middle-income countries have found that zinc supplementation of young children (in the form of liquid supplements or dispersible tablets) increases linear growth and weight gain, and reduces the prevalence of diarrhea and respiratory infections, and lowers all-cause mortality. Aside from supplements, additional dietary zinc can also be provided through "home-fortification" of complementary foods with small-quantity lipid-based nutrient supplements (SQ-LNS; 20g/d), which are typically formulated as a peanut-based paste enriched with a vitamin and mineral complex containing 8 mg elemental zinc (as ZnSO4). However, the efficacy of LNS as a delivery vehicle for preventive zinc supplementation remains uncertain. Two recent studies, which provided LNS containing 4-10 mg Zn daily for 6-9 months found no significant differences in plasma zinc concentrations at the end of the intervention period compared to placebo. This lack of response may be due to the reduced absorption of zinc when it is part of a complex food matrix and provided with cereal-based meals; both SQ-LNS and cereal grains contain moderate to high concentrations of phytate, the main dietary factor known to substantially reduce zinc absorption. The addition of exogenous phytases is an efficacious strategy to reduce the phytate content of foods, and increase the bioavailability of dietary zinc; however, the efficacy of this approach has not yet been demonstrated for SQ-LNS. Objective: The overall objective of the study is to assess the efficacy of adding exogenous phytase to SQ-LNS by investigating intra-individual differences in the fractional absorption of zinc (FAZ) among children who receive additional dietary zinc (8 mg/d) from SQ-LNS with or without phytase. Trial approach: The study will be a double-blind randomized controlled clinical trial, designed to permit within-child comparisons of zinc absorption from SQ-LNS, with or without exogenous phytase, by using the triple stable-isotope ratio tracer technique. The clinical study will enroll 34 children between the ages of 18-23 months. The main outcome of interest is the intra-individual difference in the FAZ from porridge-based meals containing SQ-LNS with and without phytase. Up to an` additional 36 children will be enrolled in a pilot feeding study to determine portion sizes of study meals. Trial setting: Keneba, The Gambia Trial interventions: The SQ-LNS (20g) used in this study will be provided by Nutriset, S.A.S. The exogenous phytase (DSM phytase Tolerase 20000G) is derived from Aspergillus niger; phytase will be added to the SQ-LNS during the production phase, and will be enzymatically active in vivo at the time of consumption. Feeding Protocol and Study Diet: The study diet for the 2day absorption study will consist of the following: 1) Two stable-isotope labeled test meals per day (porridge made from locally procured non-fermented cereal, mixed with 10 g of SQ-LNS), with children randomized to receive either SQ-LNS with phytase or SQ-LNS without phytase on the first day and the alternative product on the second; 2) One additional standardized meal per day (e.g. rice with sauce); 3) Low-zinc, low-phytate food (e.g. bananas) consumed ad libitum if requested (with the exception of 1 hour before and 2 hours after each test meal). Children will be fed by their caregivers under supervision by a study fieldworker. The SQ-LNS product (without phytase) will be provided to children twice per day for one day prior to the start of the stable isotope absorption studies, in order to habituate children to the study diet and location. Children will attend the study clinic daily for four days and will be enrolled in the study for a total of ten days. Zinc absorption studies: The FAZ of zinc will be measured by a triple-isotope tracer ratio technique, using orally administered extrinsic labels (Zn-67 and Zn-70) and intravenous Zn-68. Urine samples, collected pre- and post-isotope administration (d 1, 5-9) will be analyzed for zinc isotope ratios by ICP-MS. FAZ will be calculated based on the mean isotopic ratios obtained from the enriched urine samples, and based on the tracer:tracee ratio method. TAZ will be calculated by multiplying FAZ by total zinc intake from the test meals. Data Collection: The following information will be collected from each subject: brief medical history; physical examination; weight and height; daily morbidity and pre-intervention blood sampling for hemoglobin, complete blood count and plasma zinc concentration, malaria and systemic inflammation (C-reactive protein and α-1-acid glycoprotein).

NCT ID: NCT02654730 Terminated - Malaria Clinical Trials

Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia

SAFEPRIM-II
Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.