There are about 69 clinical studies being (or have been) conducted in Gabon. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
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.
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.
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.
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.