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NCT ID: NCT05929157 Not yet recruiting - Clinical trials for Severe Malarial Treatment

A Crossover Bioavailability Clinical Trial of Parenteral Pyronaridine and Artesunate

Start date: September 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The clinical trial is a Phase I monocentric clinical trial with a two-armed crossover design to evaluate the bioavailability of parenteral Pyronaridine and Artesunate. Pyronaridine and Artesunate are antimalarial agents with a history of clinical use, and Artesunate has been used clinically in combination with other drugs also. The action of Artesunate is a rapid knock down of the parasites, after which, the drug is quickly cleared as it has a short systemic half-life. Pyronaridine is also rapidly effective in the short term but has a long blood half-life thus providing a more sustained schizonticidal effect. 12 study subjects will be included into the clinical trial after having signed the informed consent, being screened and judged to be eligible. 6 of them (group 1) will, on Day 0, be injected intravenously with 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate. The group 2 (the other 6 subjects) will on the same day (Day 0) be injected intramuscularly with the 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate (into separate sites) 8 weeks later group 1 will be injected intramuscularly with the same amount of Pyronaridine and Artesunate as on Day 0. Group 2 will also get the same amount as on Day 0 but this time the injection will be intravenously for group 2. The primary objective is to assess the safety and tolerability by measuring (a) the proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) throughout the study; (b) the proportion of subjects with solicited AEs 15 days after IMP injection; (c) the proportion of subjects with unsolicited AEs throughout the clinical trial. Further, the pharmacokinetics of both drugs will be determined.

NCT ID: NCT05905432 Not yet recruiting - Malaria Clinical Trials

Pan-Malaria Transmission-Blocking Vaccine AnAPN1

PamTBVac
Start date: July 25, 2023
Phase: Phase 1
Study type: Interventional

Malaria is still responsible for more than 627,000 deaths each year, predominantly among children under 5 years old. Current reductions in deaths have stagnated, and additional setbacks for malaria control programs due to the Coronavirus Disease 2019 (COVID-19) pandemic are expected. To achieve malaria elimination and eradication a leverage concerted approaches to reduce clinical disease and prevent new infections is a must. The existing malaria controls tools including the a recombinant protein-based malaria vaccine (RTS,S ,(trade name MosquirixMosquirix )), a malaria vaccine currently undergoing implementation studies and endorsed by the World Health Organization on October 7, 2021, can reduce disease burden for patients but cannot ultimately support malaria elimination and eradication since their effect on malaria transmission is at most partial. Consequently, complementary interventions, such as transmission-blocking vaccines (TBVs) may prove to be a cost-effective intervention that can reduce on-going residual transmission and the cascade of new infections.

NCT ID: NCT05865626 Completed - Tuberculosis Clinical Trials

Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

dotsapp
Start date: October 10, 2018
Phase: N/A
Study type: Interventional

This pilot study aimed to assess the feasibility of using an instant messenger to monitor drug intake in tuberculosis patients and to assess cash incentive to improve adherence to drug intake

NCT ID: NCT05807399 Recruiting - Clinical trials for Pulmonary Tuberculosis

PanACEA - STEP2C -01

Start date: April 14, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing sutezolid will be added. Participants will be allocated to control or one of the three experimental regimens in the ratio 1:1:1:1. Towards the end of stage 2, when experimental arms 1 and 2 will be fully enrolled, participants will be randomized 1:1 to control and experimental arm 4. The objective is to evaluate the efficacy, safety, and tolerability of increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin, and sutezolid, in adult subjects with newly diagnosed, smear-positive pulmonary tuberculosis.

NCT ID: NCT05689047 Recruiting - Acute Malaria Clinical Trials

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Start date: March 29, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.

NCT ID: NCT05311891 Not yet recruiting - COVID-19 Clinical Trials

Variants of SARS-CoV-2 Causing COVID-19 in Africa

South-Spike
Start date: September 2022
Phase:
Study type: Observational

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

NCT ID: NCT05303168 Active, not recruiting - COVID-19 Clinical Trials

Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

MA-CoV
Start date: July 1, 2021
Phase:
Study type: Observational [Patient Registry]

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed. The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

NCT ID: NCT05222139 Recruiting - Clinical trials for SARS CoV 2 Infection

Monitoring COVID-19 Vaccination Response in Fragile Populations

ORCHESTRA-4
Start date: May 24, 2021
Phase:
Study type: Observational

The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic. ORCHESTRA provides an innovative approach to learn from the pandemic SARS-CoV-2 crisis, derive recommendations to further management of COVID-19 and be prepared for the possible future pandemic waves. The ORCHESTRA project aims to deliver sound scientific evidence for the prevention and treatment of the infections caused by SARS-CoV-2 assessing epidemiological, clinical, microbiological, and genotypic aspects of population, environment and socio-economic features. The project builds upon existing, and new largescale population cohorts in Europe (France, Germany, Spain, Italy, Belgium, Romania, Netherlands, Luxemburg, and Slovakia) and non-European countries (India, Perú, Ecuador, Colombia, Venezuela, Argentina, Brazil and Gabon) including SARS-CoV-2 infected and non-infected individuals of all ages and conditions. The primary aim of ORCHESTRA is the creation of a new pan European cohort applying homogenous protocols for data collection, data sharing, sampling, and follow-up, which can rapidly advance the knowledge on the control and management of the COVID-19. ORCHESTRA will include SARS-CoV-2-negative individuals and thereby enable a prospective follow-up and an analysis of vaccination response. The cohort will involve four different populations: general population, COVID-19 patients, fragile individuals (children, elderly, transplanted, oncological, HIV infected, and those with Parkinson disease), and health-care workers. Each of these "perpetual" cohorts can answer different research questions and vaccine strategies. Within the ORCHESTRA project, the Work Package 4 (WP4) will focus on the cohort of fragile patients including pregnant women/new-born, children, patients with HIV infection, patients with autoimmune disease, solid organ transplant recipients, patients with oncological and hematological diseases, patients with cystic fibrosis, patients with Parkinson Disease and rheumatological diseases from from 14 countries (5 European and 9 non-European countries), with approximately 20000 subjects.

NCT ID: NCT05130398 Completed - Ebola Virus Disease Clinical Trials

Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

EBOLAPED
Start date: April 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector. The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination. The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

NCT ID: NCT05065632 Recruiting - Clinical trials for Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms

Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon

Sero-CoV
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Most of the individuals infected by SARS-CoV-2 are asymptomatic and they represent a major source of viral spread. To date, African countries have been less affected by deaths caused by the Covid-19 pandemic compared to other countries. It is currently unknown why Africa has avoided more deaths and appears to not simply be due to a lack of testing, since the overall death rate has not increased. Better quality data on seroprevalence in different African regions and proven explanations of the differences between Africa and other continents, are urgently needed. The aim of this study is to learn about the proportion of people after a first pic of transmission, who have been exposed to COVID-19 in Gabon by testing for plasma antibodies to the SARS-CoV-2 virus. The overall goal of this study is to examine the trend of specific anti-SARS-CoV-2 antibodies in Gabonese population.