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NCT ID: NCT04795648 Not yet recruiting - Malaria Clinical Trials

Spatial Repellents for Vector Control

AEGIS Mali RCT
Start date: April 2021
Phase: N/A
Study type: Interventional

The primary objective of the study is to demonstrate and quantify the protective efficacy of a single SR product, in reducing malaria infection in a human cohort. The study design will be a prospective cluster Randomized Control Trial (cRCT).

NCT ID: NCT04710316 Not yet recruiting - Covid19 Clinical Trials

Study of COVID-19 Outbreak in Hospital Departments of Bamako, Mali

BAMACOV
Start date: January 30, 2021
Phase: N/A
Study type: Interventional

The new coronavirus known as SARS-Cov-2 (severe acute respiratory syndrome -coronavirus 2) was first reported in December 2019 and rapidly became a public health emergency. The COVID-19 pandemic is now affecting sensitive regions with fragile health care systems, such as South America and Africa. Caregivers, in the front line of Covid19 patient management, may accidentally become infected and a source of infection during the incubation phase or in case of asymptomatic infection. The objectives of this project are thus i) to assess SARS-Cov-2 spread over the hospital departments of Bamako by carrying out a systematic molecular screening of patients and caregivers, ii) to evaluate the feasibility of Point-Of-Care molecular assays in Mali and iii) to estimate the immunity acquired from SARS-Cov-2 among health workers through serological testing, allowing also the assessment of asymptomatic caregiver rate and absence of re-infection among the immunized caregivers. Finally, iv) variability of the virus over time and spread of different variants around the world will be studied by sequencing the viral genome.

NCT ID: NCT04665791 Recruiting - Clinical trials for Meningitis, Meningococcal

A Human Controlled Infection Study With Neisseria Lactamica in Malian Adults

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

This study is part of a series of projects to improve protection against meningitis. Previously, researchers have given nose drops containing N. lactamica to over 400 volunteers and shown that many of them become colonised with N. lactamica without causing any illness or disease. This has previously been shown to prevent people from becoming colonised with N. meningitidis which can cause meningitis. This study aims to give nose drops containing N. lactamica to healthy adults in Mali, to see if they become safely colonised. In the future the study team would like to find out how N.lactamica helps children resist N.meningitidis, and develop new vaccines that exploit that mechanism.

NCT ID: NCT04609098 Completed - Malaria, Falciparum Clinical Trials

Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)

NECTAR2
Start date: October 29, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the gametocytocidal and transmission reducing activity of dihydroartemisinin-piperaquine (DP) with and without various low doses of tafenoquine (TQ; 1.66mg/kg, 0.83mg/kg, or 0.415mg/kg). Outcome measures will include infectivity to mosquitoes at 2 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density.

NCT ID: NCT04602676 Completed - Clinical trials for Clinical Decision-Making

The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

This is a randomized crossover study, where clinicians will be randomized to periods where they will use a rehydration calculator application with or without the Diarrheal Etiology Prediction (DEP) algorithm. The crossover will include a washout period to reduce carryover effect. The study will be conducted over a 9-week period. The Investigators will use a random number generator to randomize clinicians to DEP (use of the etiology calculator) or control arm (use of a previously-tested rehydration calculator) within site for the first 4 weeks. After the first 4 weeks, there will be 1-week washout period without decision support, after which each clinician will cross-over to the other arm for the next 4 weeks. The Investigators will enroll diarrhea-treating clinicians who treat children presenting with acute diarrhea at sites in Bangladesh and Mali. Utah investigators will only analyze de-identified data provided by our collaborators in Bangladesh and Mali.

NCT ID: NCT04546633 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria

Start date: February 16, 2021
Phase: Phase 2
Study type: Interventional

This study aims to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance, and for a duration shorter than 3 days of treatment and/or reduced pill burden.

NCT ID: NCT04482010 Recruiting - HIV Infections Clinical Trials

ANRS 12392 Sanu Gundo

SANU GUNDO
Start date: November 29, 2020
Phase: N/A
Study type: Interventional

Sanu Gundo ANRS 12392 is a non-randomized and non-comparative intervention trial in Mali. The main objective of the project is to study the feasibility of the community-based HIV care in the context of the artisanal gold mining zones and to evaluate its contribution to the linkage-to-care of PLWHIV with the health system and their retention in care, as well as its effect on their health status.

NCT ID: NCT04450498 Recruiting - Clinical trials for Neisseria Meningitides Meningitis

A Study to Demonstrate Non-inferior Immunogenicity of Yuxi Walvax MPV ACYW® Vaccine in Healthy Subjects Aged 2-10 Years

Start date: December 23, 2020
Phase: Phase 4
Study type: Interventional

This is a phase IV, single-center, observer-blind, randomized, controlled vaccine trial in 2 to 10 years old healthy subjects. Each participant will receive a single intramuscular injection of one of the two vaccines either MPV ACYW® vaccine or Menactra ® vaccine according to the vaccine group assignment and will be followed up for one month for immunogenicity evaluation and for 6 months for safety evaluation. Statistical Hypothesis: H0: Seroconversion rate of test group is inferior to that of control group HA: Seroconversion rate of test group is non-inferior to that of control group Sample size calculation: the sample size was calculated based on non-inferiority test with alpha level of 0.025 and 80% power, assuming seroconversion rate in control group was 95% with non-inferiority margin at 10%. The sample size required for the study is 124 per arm. After adjusting for 5% drop-out, the final sample size required is 130 per arm.

NCT ID: NCT04424511 Recruiting - Mortality Clinical Trials

Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali

LAKANA
Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

The LAKANA trial will assess the impact on mortality and other health outcomes of quarterly and biannual azithromycin mass drug administration (MDA) when delivered to 1-11-month old infants in a high-mortality setting where malaria is holoendemic but there is also a functioning seasonal malaria chemoprevention (SMC) program in place. The long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality, and to determine the most effective treatment regimen. The main study hypotheses in terms of mortality effect are: i) Biannual azithromycin MDA to 1-11 month old infants reduces their mortality, ii) Quarterly azithromycin MDA to 1-11 month old infants reduces their mortality, iii) Quarterly azithromycin MDA has a bigger mortality effect than biannual MDA.

NCT ID: NCT04329104 Recruiting - Malaria Clinical Trials

Anti-malaria MAb in Mali

Start date: February 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.