Clinical trials: completed, 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 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
Multi-drug Resistant Tuberculosis
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
- Trial name
- TB-MR (NCT03057756)
- Testing
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Where
- Gabon
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
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
SARS CoV 2 Infection, Vaccination; Infection
Monitoring COVID-19 Vaccination Response in Fragile Populations
The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic.
- Conditions
- SARS CoV 2 Infection, Vaccination; Infection, Breakthrough Infection
- Trial name
- ORCHESTRA-4 (NCT05222139)
- Testing
- COVID-19 vaccination
- Where
- 20 sites in Argentina, Gabon and 5 more
- Volunteers
- 8,894 people
- Sponsor
- University of Bologna
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.
Hookworm Disease, Hookworm Infection
Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon.
- Trial name
- NCT02839161
- Testing
- Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel, Hepatitis B Vaccine
- Where
- Gabon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Malaria, HIV/AIDS
Improving Maternal heAlth by Reducing Malaria in African HIV Women
Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting…
- Conditions
- Malaria, HIV/AIDS, Pregnancy Related
- Trial name
- MAMAH (NCT03671109)
- Testing
- Dihydroartemisinin-piperaquine (DHA-PPQ)
- Where
- 2 sites in Gabon, Mozambique
- Volunteers
- 666 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
SARS-CoV2 Infection, COVID-19
Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations
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…
- Trial name
- MA-CoV (NCT05303168)
- Where
- 2 sites in Gabon, Mozambique
- Volunteers
- 1,000 people
- Sponsor
- Barcelona Institute for Global Health
Vitamin D Deficiency, Immunosuppression
Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study
Purpose: To examine whether helminth infection during pregnancy alters Vitamin-D-metabolism and reactivity of the child's immune system Hypothesis: Helminth infection during pregnancy is associated with altered Vitamin D levels…
- Trial name
- HELMVIT (NCT04324853)
- Testing
- Microscopy ( Urine filtration), UCAA test, qPCR,, Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,
- Where
- Gabon
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Ebola Virus Disease
Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon
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…
- Trial name
- EBOLAPED (NCT05130398)
- Testing
- rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch, Active detection and treatment of pathogens
- Where
- Gabon
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Coronavirus Infection, Africa
Important Data on COVID-19 Profile in Africa
The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal…
- Trial name
- AIDCO (NCT04847817)
- Where
- 2 sites in Gabon
- Volunteers
- 574 people
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Uncomplicated Plasmodium Falciparum Malaria
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.
- Trial name
- NCT00331136
- Testing
- Pyronaridine-Artesunate
- Where
- Gabon
- Volunteers
- 60 people
- Sponsor
- Medicines for Malaria Venture
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
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture
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.
Helminths Infection, Drug Resistance
Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world.
- Trial name
- BenziR (NCT04326868)
- Testing
- Benzimidazole Anthelmintic
- Where
- Gabon
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné