Clinical trials: in Democratic Republic of the Congo
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
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Mpox (Monkeypox), Smallpox
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
- Conditions
- Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
- Trial name
- NCT07379580
- Testing
- BNT166a
- Where
- 6 sites in Democratic Republic of the Congo, South Africa
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
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
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
Monkeypox (Mpox)
Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).
- Trial name
- NCT06549530
- Testing
- MVA-BN
- Where
- 3 sites in Democratic Republic of the Congo, Uganda
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
COVID-19
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older
- Trial name
- NCT05603052
- Testing
- EuCorVac-19, ChAdOx1 nCoV-19
- Where
- Democratic Republic of the Congo
- Volunteers
- 2,852 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
HPV-induced Cancers, HPV Infections
Tolerance and Effectiveness of C14 on HPV Infection
The zinc monoterpenoid tetra-ascorbo-camphorate possesses broad-spectrum anti-viral properties in vitro, particularly against HIV, HSV and HPV.
- Conditions
- HPV-induced Cancers, HPV Infections, HIV, Cervical Cancers
- Trial name
- PREPAP (NCT06672653)
- Testing
- The monoterpenoid zinc tetra-ascorbo-camphorate ("C14"), Distilled water group
- Where
- Democratic Republic of the Congo
- Volunteers
- 66 people
- Sponsor
- MGB Pharma
Onchocerciasis
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection
Onchocerciasis is a major public health problem in affected countries that causes disease-induced disability, and overall loss of economic productivity.
- Trial name
- NCT04913610
- Testing
- ABBV-4083, Albendazole
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 153 people
- Sponsor
- AbbVie
Zoonotic Disease
Viral and Microbial Circulation Between Humans, Domesticated and Wild Animals Along an Ecotone, Democratic Republic of Congo
This study will evaluate the overlap between the intestinal microbiome and virome of wild and domesticated animals and human beings living in close proximity in three sites along an ecotone (ecological gradient) in the Democratic…
- Trial name
- MICROTONE (NCT04012164)
- Testing
- blood sampling, stool collection, Participatory activity and contact investigation
- Where
- Democratic Republic of the Congo
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Covid19, COVID-19 Pneumonia
imPulse™ Una Infrasound-to-ultrasound E-stethoscope
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of…
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- Trial name
- NCT04941209
- Testing
- imPulse™ Una infrasound-to-ultrasound e-stethoscope, (PPA >95%) FDA EUA RT-PCR, HR-CT-scan
- Where
- 3 sites in Democratic Republic of the Congo, India and 1 more
- Volunteers
- 702 people
- Sponsor
- Level 42 AI, Inc.
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,Falciparum
A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria
There is a need for paediatric formulations that permit accurate dosing and enhance patient compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations are available on the market.
- Trial name
- NCT01992900
- Testing
- Eurartesim dispersible oral tablet, eurartesim film coated tablet
- Where
- 7 sites in Burkina Faso, Democratic Republic of the Congo and 3 more
- Volunteers
- 300 people
- Sponsor
- sigma-tau i.f.r. S.p.A.