Clinical trials: completed, in Democratic Republic of the Congo
Respiratory Depression Neonatal
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a mobile health application called LIVEBORN; secondarily, to evaluate the relative effectiveness of real-time guidance vs debriefing.
- Trial name
- NCT05963516
- Testing
- LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation, NeoBeat: Heart Rate Meter for Newborn Resuscitation
- Where
- 4 sites in Democratic Republic of the Congo
- Volunteers
- 14,679 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Monkey Pox, Monkeypox
Mpox Paediatric and Adolescent Clinical Study
The goal of this multicentre, observational study on mpox in infants, children and adolescents is to increase knowledge about mpox infection and its associated disease in infants, children and adolescents.
- Trial name
- NCT05947786
- Where
- 6 sites in United States, Democratic Republic of the Congo and 4 more
- Volunteers
- 1,108 people
- Sponsor
- PENTA Foundation
Ebola Virus Disease
Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola
This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care…
- Trial name
- EBOVAC3DRC (NCT04186000)
- Testing
- Ad26.ZEBOV vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
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
Onchocerciasis
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in…
- Trial name
- NCT04311671
- Testing
- Moxidectin, Ivermectin, Albendazole
- Where
- 2 sites in Côte d’Ivoire, Democratic Republic of the Congo
- Volunteers
- 12,979 people, healthy volunteers welcome
- Sponsor
- Medicines Development for Global Health
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)
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)
Trypanosomiasis, African, Gambiense Trypanosomiasis
Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense
The goal of this study is to assess efficacy and safety of acoziborole in adult participants with Trypanosoma brucei gambiense (T.b.
- Conditions
- Trypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness
- Trial name
- OXA002 (NCT03087955)
- Testing
- Acoziborole
- Where
- 12 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 208 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA004 (NCT05256017)
- Testing
- Acoziborole
- Where
- 7 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 1,208 people
- Sponsor
- Drugs for Neglected Diseases
Febrile Illness
Febrile Illness in Kinshasa and Kimpese
This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical…
- Trial name
- FIKI² (NCT04760678)
- Testing
- Observational study
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 1,046 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease.
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosomiasis; Gambian
- Trial name
- NCT03025789
- Testing
- Fexinidazole
- Where
- 8 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 174 people
- Sponsor
- Drugs for Neglected Diseases
Premature Birth
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth.
- Trial name
- ASPIRIN (NCT02409680)
- Testing
- Low dose aspirin
- Where
- 14 sites in United States, Democratic Republic of the Congo and 5 more
- Volunteers
- 11,976 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Neurodevelopmental Abnormality
ASPIRIN: Neurodevelopmental Follow-up Trial
A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo.
- Trial name
- NCT04888377
- Testing
- Aspirin
- Where
- 14 sites in United States, Democratic Republic of the Congo and 4 more
- Volunteers
- 666 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Malnutrition, Manihot Species Poisoning
Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC)
The proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo…
- Trial name
- NCT04036708
- Testing
- Wetting method (WTM), Mediational Intervention for Sensitizing Caregivers (MISC)
- Where
- Democratic Republic of the Congo
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Michigan State University
Tuberculosis, Pediatric
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and…
- Trial name
- TIPPI (NCT03948698)
- Testing
- Innovative approached to pediatric TB care
- Where
- 10 sites in Cameroon, Côte d’Ivoire and 8 more
- Volunteers
- 4,159,533 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
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
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults…
- Trial name
- NCT00422084
- Testing
- Pyronaridine artesunate, Coartem® (artemether lumefantrine)
- Where
- 10 sites in Democratic Republic of the Congo, Ghana and 7 more
- Volunteers
- 1,272 people
- Sponsor
- Medicines for Malaria Venture
Ebola Virus
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
Background: Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give.
- Trial name
- NCT03719586
- Testing
- ZMapp, Remdesivir, MAb114
- Where
- 2 sites in United States, Democratic Republic of the Congo
- Volunteers
- 681 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis B, Vertical Transmission of Infectious Disease
Arresting Vertical Transmission of Hepatitis B Virus
The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.
- Trial name
- AVERT-HBV (NCT03567382)
- Testing
- Tenofovir Disoproxil Fumarate, Monovalent HBV vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 179 people
- Sponsor
- University of North Carolina, Chapel Hill