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NCT ID: NCT04711356 Not yet recruiting - Ebola Virus Disease Clinical Trials

Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later.

NCT ID: NCT04334538 Recruiting - Malnutrition, Child Clinical Trials

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.

NCT ID: NCT04216043 Recruiting - Malnutrition, Child Clinical Trials

Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

Start date: September 16, 2020
Phase: N/A
Study type: Interventional

This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.

NCT ID: NCT04121234 Completed - Maternal Death Clinical Trials

Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting

Start date: May 1, 2018
Phase:
Study type: Observational

Sierra Leone faces the highest maternal mortality ratio in the world. Despite this extreme burden, the potential roles of obstetric critical care and high dependency units (HDUs) in this and other resource-limited settings remain scarcely explored. This study investigated epidemiology, clinical outcomes and risk factors for mortality in critically-ill parturients admitted to an obstetric HDU in a high volume, urban resource-limited maternity hospital.

NCT ID: NCT04112680 Completed - Misinformation Clinical Trials

Contagious Misinformation Trial

CMT
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

In the Contagious Misinformation Trial the investigators aim to debunk prevalent misinformation about an infectious disease using two evidence-based methods of debunking. The two debunking methods are packaged in two audio dramas of 4 episodes each, which will be sent to the WhatsApp of participants who are randomised to intervention group 1 or 2. The control group will receive audio messages about a different topic. The primary outcome is the reduction in belief in two misinformation statements about the infectious diseases.

NCT ID: NCT04038632 Recruiting - Clinical trials for Tuberculosis in Children

TB-Speed Decentralisation Study

Start date: June 30, 2019
Phase: N/A
Study type: Interventional

The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e. Nasopharyngeal Aspirate (NPA) and stool samples, sensitive microbiological detection tests (Ultra) close to the point-of-care (Omni/G1(Edge)), reinforced training on clinical diagnosis, and standardized CXR quality and interpretation using digital radiography. The TB-Speed Decentralisation study will evaluate the impact of an innovative patient care level diagnostic approach deployed at DH and PHC levels, namely the DH focused and the PHC focused decentralization strategies. This is aimed at, improving case detection in 6 high TB incidence in low/moderate resource countries: Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda, and compare effectiveness and cost-effectiveness of the two different decentralization approaches. The hypothesis is that, in countries with high and very high TB incidence (100-299 and ≥300 cases/100,000 population/year, respectively), a systematic approach to the screening for and diagnosis of TB in sick children presenting to the health system will increase childhood TB case detection, especially PTB, which represents the majority of the disease burden (>75% of case)(40). The study also hypothesizes that sputum collection using battery-operated suction machines and microbiological TB diagnosis using Omni/G1 (Edge) can be decentralized to PHC level, thus enabling TB diagnosis and treatment in children at PHC level.

NCT ID: NCT04016870 Enrolling by invitation - Bradycardia Clinical Trials

Project My Heart Your Heart: Pacemaker Reuse

MHYH
Start date: October 13, 2018
Phase: N/A
Study type: Interventional

Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.

NCT ID: NCT03929991 Recruiting - Infection Clinical Trials

Maternal Cesarian Section Infection (MACSI) in Sierra Leone

MACSI
Start date: May 1, 2018
Phase:
Study type: Observational

Up to 1 in 5 women in Africa who deliver their baby by cesarean section get a wound infection. Surgical site infections (SSIs) are largely preventable, but they represent a considerable burden for health-care systems, particularly in low-income and middle-income countries. The prevention of these infections is complex and requires the integration of a range of preventive measures before, during, and after surgery. The aim of the proposed project is to determine the risk factors of Surgical Site Infection post-Cesarean Section in women admitted to Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone. Secondary aims are to determine the incidence of SSI and the predictors of a negative outcome in women with post-CS SSI.

NCT ID: NCT03929757 Completed - Ebola Virus Disease Clinical Trials

A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants

Start date: August 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively.

NCT ID: NCT03889106 Recruiting - Lassa Fever Clinical Trials

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Start date: March 1, 2019
Phase:
Study type: Observational

Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies. Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.