Clinical trials: in Democratic Republic of the Congo
Female Genital Schistosomiasis
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis (FGS) is a neglected complication of Schistosoma haematobium infection affecting an estimated 56 million women and girls globally, with a high burden in sub-Saharan Africa.
- Trial name
- WINGS-4-FGS (NCT07915518)
- Testing
- Praziquantel 80, Prednisolone, Diclofenac
- Where
- 4 sites in Côte d’Ivoire, Democratic Republic of the Congo and 2 more
- Volunteers
- 800 people
- Sponsor
- Brian Ngwira
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
Malaria,Falciparum, Malaria in Pregnancy
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL)…
- Conditions
- Malaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, Pregnancy
- Trial name
- INTREPiD (NCT05757167)
- Testing
- Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
- Where
- 2 sites in Democratic Republic of the Congo, Kenya
- Volunteers
- 2,174 people
- Sponsor
- Duke University
Rift Valley Fever, Hemorrhagic Fevers, Viral
RVF and Other Emerging Infectious Diseases in East and Central Africa
Rift Valley fever (RVF), a disease transmitted from livestock (cattle, sheep, goats, camels) to humans more commonly occurs in the East and Central Africa (ECA) regions where more than 15 major epidemics affecting more than one…
- Trial name
- NCT05139524
- Testing
- Evidence of past or recent RVF exposure
- Where
- 10 sites in Democratic Republic of the Congo, Kenya and 2 more
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Washington State University
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Bundibugyo virus (BDBV) causes severe and often fatal outbreaks of Bundibugyo virus disease (BVD). No vaccine against BDBV is licensed.
- Trial name
- TUMAINI (NCT07842107)
- Testing
- Candidate BDBV vaccine, Active comparator
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,620 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Compliant Behavior, Morbidity;Infant
Financially-Incentives to Improve Provider Compliance
The main objective of this study is to assess whether making health financing streams conditional on provider performance on knowledge assessment can increase provider compliance with under-5 case management guidelines.
- Trial name
- NCT04634019
- Testing
- Financially incentivized knowledge assessments
- Where
- 2 sites in Democratic Republic of the Congo, Switzerland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Swiss Tropical & Public Health Institute
Plague, Bubonic; Plague, Skin
Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.
This study is being done to learn more about the disease in Ituri and to evaluate a new rapid test that may help doctors find the disease more quickly.
- Conditions
- Plague, Bubonic; Plague, Skin, Plague, Pneumonic
- Trial name
- RAPID-IT (NCT07174648)
- Where
- Democratic Republic of the Congo
- Volunteers
- 300 people
- Sponsor
- Institute of Tropical Medicine, Belgium
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
Mpox (Monkeypox), Mpox
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of…
- Trial name
- MPX-001 (NCT07093489)
- Testing
- LC16m8
- Where
- Democratic Republic of the Congo
- Volunteers
- 11,990 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense
Stop Transmission of Gambiense Human African Trypanosomiasis
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested…
- Trial name
- STROgHAT (NCT07789743)
- Testing
- Acoziborole
- Where
- Democratic Republic of the Congo
- Volunteers
- 2,500 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkeypox
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
- Trial name
- SMART (NCT05745987)
- Testing
- Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution
- Where
- 10 sites in Democratic Republic of the Congo, Nigeria and 1 more
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- McMaster University
Bacteremia
Surveillance of AMR in DRC
This study addresses knowledge gaps regarding antimicrobial resistance (AMR) in sub-Saharan Africa, focusing on evaluating the feasibility of AMR surveillance and enhancing local research capacity.
- Trial name
- SARKIN (NCT06821282)
- Where
- Democratic Republic of the Congo
- Volunteers
- 210 people
- Sponsor
- University of Oxford
Postpartum Anemia
Prevention of Iron Deficiency Anemia Post-delivery
PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth.
- Trial name
- PRIORITY (NCT05590260)
- Testing
- Ferric carboxymaltose (FCM) and folic acid tablets, Oral iron tablets and folic acid tablets
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 4,857 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Sickle Cell Disease
Realizing Effectiveness Across Continents With Hydroxyurea (REACH)
REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for for pediatric patients with sickle cell anemia (SCA).
- Trial name
- REACH (NCT01966731)
- Testing
- Hydroxyurea
- Where
- 4 sites in Angola, Democratic Republic of the Congo and 2 more
- Volunteers
- 635 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Hypoxic Ischemic Encephalopathy (HIE)
Caffeine for Hypoxic Ischemic Encephalopathy
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE).
- Trial name
- CHIME (NCT06855108)
- Testing
- Caffeine citrate oral solution
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 830 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Mpox
Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC
The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory…
- Trial name
- NCT07634081
- Testing
- SDS-EDTA-treated chromatography strip
- Where
- Democratic Republic of the Congo
- Volunteers
- 150 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Mpox (Monkeypox)
Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities.
- Trial name
- MOVIE-TRACE (NCT07267390)
- Where
- Democratic Republic of the Congo
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Mpox (Monkeypox), Vaccination
Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 double-blinded, randomized study aims to evaluate the safety and immunogenicity of the two-dose MVA-BN mpox vaccine regimen, administered subcutaneously, in infants and children aged 4 to 24 months in the Democratic…
- Conditions
- Mpox (Monkeypox), Vaccination, Immunogenicity, Safety
- Trial name
- PregInPoxVac (NCT06844487)
- Testing
- MVA-BN standard regimen, MVA-BN half-dose regimen
- Where
- Democratic Republic of the Congo
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Sickle Cell Disease, Children
Realizing Effectiveness Across Continents With Hydroxyurea
REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age.
- Trial name
- REACH (NCT06171217)
- Testing
- Hydroxyurea
- Where
- 4 sites in Angola, Democratic Republic of the Congo and 2 more
- Volunteers
- 811 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati