Clinical trials: in Gabon
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 32 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811908)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1)
This is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811882)
- Testing
- KAE609 (Cipargamin), SoC (Coartem), INE963
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07235033)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 3 sites in Côte d’Ivoire, Gabon and 1 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
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
This study aimed 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…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
- Trial name
- PLATINUM (NCT05750628)
- Testing
- INE963, KAE609 (Cipargamin), SoC (Coartem)
- Where
- 12 sites in Burkina Faso, Côte d’Ivoire and 4 more
- Volunteers
- 327 people
- Sponsor
- Novartis Pharmaceuticals
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Plasmodium Falciparum Infection
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.
- Trial name
- FALCI (NCT02497612)
- Testing
- Ferroquine SSR97193, Artefenomel
- Where
- 12 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 377 people
- Sponsor
- Sanofi
Plasmodium Falciparum Infection
Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction…
- Trial name
- NCT03660839
- Testing
- Artefenomel (OZ439), Ferroquine (SSR97193)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 140 people
- Sponsor
- Sanofi
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Africa
The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).
- Trial name
- NCT01190202
- Testing
- Blood sampling, Assessment of body temperature
- Where
- 8 sites in Burkina Faso, Gabon and 4 more
- Volunteers
- 21,618 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
- Trial name
- NCT00866619
- Testing
- Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, Cell-culture rabies vaccine
- Where
- 10 sites in Burkina Faso, Gabon and 5 more
- Volunteers
- 15,459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria,Falciparum
Cohort Event Monitoring Study of Pyramax®
The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes.
- Trial name
- NCT03201770
- Testing
- pyronaridine artesunate
- Where
- 5 sites in Cameroon, Côte d’Ivoire and 3 more
- Volunteers
- 8,572 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Malaria
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first…
- Trial name
- NCT00436007
- Testing
- GSK 257049, Tritanrix™ HepB/Hib, Rouvax™
- Where
- 3 sites in Gabon, Ghana and 1 more
- Volunteers
- 511 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas.
- Trial name
- NCT00307021
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
- Where
- Gabon
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: To assess the evolution…
- Trial name
- NCT01445938
- Testing
- SAR97276A, arthemeter + lumefantrine (ACTs)
- Where
- 4 sites in Benin, Burkina Faso and 2 more
- Volunteers
- 20 people
- Sponsor
- Sanofi
Plasmodium Falciparum Infection
Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment.
- Trial name
- FARM (NCT00988507)
- Testing
- Ferroquine (SSR97193), artesunate
- Where
- 10 sites in Benin, Burkina Faso and 4 more
- Volunteers
- 440 people
- Sponsor
- Sanofi
Malaria
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
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…
- Trial name
- NCT01361269
- Testing
- Fosmidomycin and clindamycin
- Where
- Gabon
- Volunteers
- 100 people
- Sponsor
- Zentopharm GmbH