Clinical trials: in Democratic Republic of the Congo
Invasive Non-Typhoidal Salmonella Disease, Malaria
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease
The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5.
- Conditions
- Invasive Non-Typhoidal Salmonella Disease, Malaria, Malaria Vaccine
- Trial name
- VINS (NCT07416461)
- Testing
- R21/Matrix-M malaria vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 10,000 people
- Sponsor
- International Vaccine Institute
Monkeypox
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo.
- Trial name
- NCT05734508
- Testing
- MVA-BN vaccine
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neonate, Maternal Transmission
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population…
- Conditions
- Neonate, Maternal Transmission, Mpox, Vaccination
- Trial name
- PregInPoxVac (NCT06844500)
- Testing
- MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
- Where
- Democratic Republic of the Congo
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Severe Malaria
Severe Malaria in Remote Areas- Closing the Evidence Gap
The goal of this observational study is to assess whether the giving of rectal artesunate and a three day course of an Artemisinin based Combination Therapy (ACT) to children aged 6 months and ≤ 5 years with severe malaria when…
- Trial name
- SEMA ReACT (NCT06806956)
- Testing
- Treatment of severe malaria with either RAS + ACT or RAS + injectable artesunate + ACT will each achieve the clinically acceptable cure rate of 97% ± 5% in remote areas
- Where
- 2 sites in Democratic Republic of the Congo, Zambia
- Volunteers
- 2,016 people
- Sponsor
- Tropical Diseases Research Centre, Zambia
Preterm Birth, Small for Gestational Age (SGA)
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants.
- Conditions
- Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy
- Trial name
- ABLE (NCT06723392)
- Testing
- Oral nitrofurantoin monohydrate/macrocrystals
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Ebola Virus Disease
EBOla Post-Exposure Prophylaxis
EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.
- Trial name
- EBO-PEP (NCT06841614)
- Testing
- Ervebo, Inmazeb
- Where
- 4 sites in Democratic Republic of the Congo, Guinea and 2 more
- Volunteers
- 160 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Severe Malaria
Clinical Prediction Models for Pediatric In-Hospital Death Risk in Congolese Severe Malaria Children Using Machine Learning Based-Algorithms
The goal of this observational study is to optimize the management of severe childhood malaria, based on understanding and controlling the severity factors of the disease in Congolese children aged 2 to 9 years (the age group at…
- Trial name
- NCT07355426
- Testing
- Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry
- Where
- Democratic Republic of the Congo
- Volunteers
- 100 people
- Sponsor
- University of Kinshasa
Pregnancy Outcome Trends in Low-resource Geographic Areas
Maternal Newborn Health Registry
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths…
- Trial name
- MNH (NCT01073475)
- Testing
- There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
- Where
- 15 sites in United States, Bangladesh and 5 more
- Volunteers
- 950,000 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Febrile Illness Acute, Biomarkers
Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
The epidemiology and outcome of febrile illnesses in the Democratic Republic of Congo (DRC) is poorly documented. The FIKI² study, a prospective observational study of community-acquired febrile illnesses coordinated by ITM and…
- Conditions
- Febrile Illness Acute, Biomarkers, Surveillance
- Trial name
- FI-CARE (NCT07345286)
- Where
- Democratic Republic of the Congo
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
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
Onchocerciasis
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O.
- Trial name
- NCT03876262
- Testing
- Moxidectin, Ivermectin
- Where
- Democratic Republic of the Congo
- Volunteers
- 323 people
- Sponsor
- Medicines Development for Global Health
COVID-19
International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries). This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs.
- Trial name
- InVITE (NCT05096091)
- Where
- 11 sites in Democratic Republic of the Congo, Guinea and 5 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cholera, Water-Related Diseases
Preventative Intervention for Cholera for 7 Days
The first objective of our study is to develop a theory-driven evidence-based targeted water, sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in South Kivu, Democratic Republic of the Congo…
- Conditions
- Cholera, Water-Related Diseases, Diarrhea Infectious
- Trial name
- PICHA-7 (NCT05166850)
- Testing
- PICHA7 mHealth program, Standard Arm
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 2,900 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Chronic Malnutrition, Stunting of Growth
Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
The goal of this clinical trial is to evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years.
- Trial name
- SANTE (NCT07284095)
- Testing
- Tenebrio Molitor powder, Control Group (Maize-Soy supplement)
- Where
- Democratic Republic of the Congo
- Volunteers
- 40 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
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
Plasmodium Falciparum Malaria (Uncomplicated)
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the…
- Trial name
- DeTACT-Africa (NCT03923725)
- Testing
- Artemether-lumefantrine+ Amodiaquine (AL+AQ), Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
- Where
- 8 sites in Burkina Faso, Democratic Republic of the Congo and 6 more
- Volunteers
- 2,583 people
- Sponsor
- University of Oxford
Monkeypox
Tecovirimat for Treatment of Monkeypox Virus
The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC).
- Trial name
- NCT05559099
- Testing
- Tecovirimat Oral Capsule
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 597 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pediatric Cancer
Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa
The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group.
- Trial name
- RFAOP (NCT03803735)
- Where
- 14 sites in Burkina Faso, Cameroon and 10 more
- Volunteers
- 10,000 people
- Sponsor
- French Africa Pediatric Oncology Group
Antimicrobial Stewardship, Drug Resistance, Bacterial
Optimising Community Antibiotic Use and Infection Control With Behavioural Interventions in Burkina Faso and DR Congo
Emergence of antibiotic resistance (AMR) is a serious concern for Low and Middle Income Countries (LMICs). Unregulated use of antibiotics, a major AMR driver, is highly prevalent in LMICs, with medicine stores as key providers.
- Trial name
- CABU-B/C (NCT05378880)
- Testing
- Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission
- Where
- 2 sites in Burkina Faso, Democratic Republic of the Congo
- Volunteers
- 5,532 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Ebola Virus Disease
Evaluation and Support to EVD Cured Patients and Their Contacts (Les Vainqueurs d'Ebola)
Ebola virus is one of the most dangerous human pathogens and is an emerging public health problem in sub-Saharan Africa. Ebola virus disease (EVD) first appeared in 1976.
- Trial name
- NCT04409405
- Where
- 4 sites in Democratic Republic of the Congo
- Volunteers
- 787 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France