Clinical trials: in Burkina Faso
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
Severe Acute Malnutrition
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who…
- Trial name
- NCT05932992
- Testing
- Mother education on how to perform MUAC assessment
- Where
- Burkina Faso
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Schistosomiasis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given…
- Trial name
- NCT05762393
- Testing
- rSm-p80 + GLA-SE
- Where
- 2 sites in Burkina Faso, Madagascar
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Severe Malaria
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
- Trial name
- NCT04675931
- Testing
- Cipargamin, IV Artesunate, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 254 people
- Sponsor
- Novartis Pharmaceuticals
Malaria Infection
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
This study evaluates the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and…
- Trial name
- NCT05974267
- Testing
- M5717 60 mg, Pyronaridine, Atovaquone-Proguanil
- Where
- 4 sites in Burkina Faso, Kenya and 2 more
- Volunteers
- 192 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Plasmodium Falciparum Malaria
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium…
- Trial name
- CALINA (NCT04300309)
- Testing
- artemether:lumefantrine (2.5 mg:30 mg)
- Where
- 3 sites in Burkina Faso, Democratic Republic of the Congo
- Volunteers
- 28 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
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Repeat Ivermectin Mass Drug Administrations for MALaria Control II
RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of…
- Trial name
- RIMDAMAL II (NCT03967054)
- Testing
- Ivermectin
- Where
- Burkina Faso
- Volunteers
- 4,124 people, healthy volunteers welcome
- Sponsor
- Brian Foy
Childhood Mortality
Community Health Azithromycin Trial in Burkina Faso
An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality.
- Trial name
- CHAT (NCT03676764)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 77,664 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malaria,Falciparum, Child, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether…
- Trial name
- RTSS-SMC (NCT04319380)
- Testing
- Tetanus/diphtheria toxoids, SMC with SP+AQ, RTS,S/AS01
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,098 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Malaria
A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine
The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan…
- Trial name
- NCT02374450
- Testing
- Blood collection
- Where
- 5 sites in Burkina Faso, Ghana and 1 more
- Volunteers
- 36,366 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hemorrhagic Fever, Ebola
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
- Trial name
- NCT02661464
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 16 sites in United States, Burkina Faso and 5 more
- Volunteers
- 677 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Child Growth, Diversity of Microbiome
MORDOR II Burkina Faso: Longitudinal Trial
Globally, childhood mortality has shown a promising downward trend in recent years, however, many sub-Saharan countries still have relatively high child mortality rates.
- Conditions
- Child Growth, Diversity of Microbiome, Child Mortality, Resistance Bacterial
- Trial name
- GAMIN (NCT03676751)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malaria
Gut and Azithromycin Mechanisms in Infants and Children II
Childhood mortality is decreasing worldwide. However, many sub-Saharan countries still have high children under 5 mortality rates.
- Trial name
- GAMINII (NCT04315272)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Childhood Mortality
Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
Although under-5 mortality rates are declining globally, neonatal mortality remains persistently high in many regions of sub-Saharan Africa.
- Trial name
- NAITRE (NCT03682653)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 21,832 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Child Development
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome.
- Trial name
- ARMCA (NCT03187834)
- Testing
- Azithromycin, Amoxicillin, Cotrimoxazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Uncomplicated Severe Acute Malnutrition
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in…
- Trial name
- SAM (NCT03568643)
- Testing
- Azithromycin, Amoxicillin
- Where
- Burkina Faso
- Volunteers
- 301 people
- Sponsor
- University of California, San Francisco
Malaria,Falciparum, Children, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine…
- Trial name
- RTSS-SMC (NCT03143218)
- Testing
- RABIPUR®, RTS,S/AS01, SMC with SP+AQ
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,920 people
- Sponsor
- London School of Hygiene and Tropical Medicine