Clinical trials: in Democratic Republic of the Congo
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
Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX): Clinical Study to Monitor the Immunological Response Following Mpox Vaccination in the City of Kinshasa, Democratic Republic of the Congo
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic…
- Trial name
- MBOTE-TRAXX (NCT07499739)
- Testing
- blood sample collection
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
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)
An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa, DRC
This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC.
- Trial name
- Mbote-HIVAX (NCT06839989)
- Testing
- Mpox vaccination with MVA-BN
- Where
- Democratic Republic of the Congo
- Volunteers
- 600 people
- Sponsor
- Institute of Tropical Medicine, Belgium
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
Monkeypox Virus Infection
JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo
Mpox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work…
- Trial name
- NCT02977715
- Testing
- JYNNEOS (Liquid Formulation), JYNNEOS (Lyophilized Formulation)
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
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
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
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA005 (NCT05433350)
- Testing
- Acoziborole
- Where
- 6 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 35 people
- Sponsor
- Drugs for Neglected Diseases
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin-related Neglected Tropical Diseases (Skin NTDs) affect about 1.8 billion people worldwide, particularly in poor and rural communities where healthcare access is limited.
- Conditions
- Skin and Connective Tissue Diseases, Neglected Tropical Diseases, Leprosy, Buruli Ulcer
- Trial name
- SkincAIr (NCT07506967)
- Testing
- A mobile app with AI functionality for diagnosing skin-related NTDs
- Where
- 5 sites in Democratic Republic of the Congo, Ethiopia and 3 more
- Volunteers
- 2,420 people
- Sponsor
- Kenya Medical Research Institute
Immune Response
Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers
During the previous Ebola virus disease (EVD) outbreaks, the institute National de Recherche Biomédicale (INRB) and other institutional's staff in Democratic Republic of the Congo (DRC) got vaccinated with the rVSV-ZEBOV vaccine.
- Trial name
- EBOSURV (NCT05313139)
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Trachoma
Azithromycin Reduction to Reach Elimination of Trachoma B
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC.
- Trial name
- ARRET (NCT06289647)
- Testing
- Azithromycin
- Where
- Democratic Republic of the Congo
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Monkeypox, Mpox (Monkeypox)
Ocular Complications of Mpox in the Democratic Republic Congo
This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox.
- Trial name
- MPOX-EYE (NCT06579885)
- Where
- Democratic Republic of the Congo
- Volunteers
- 320 people
- Sponsor
- Institute of Tropical Medicine, Belgium
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
Retinoblastoma
Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and…
- Trial name
- GFARB12019 (NCT04425434)
- Testing
- OBSERVATIONAL
- Where
- 7 sites in Burkina Faso, Côte d’Ivoire and 4 more
- Volunteers
- 3,000 people
- Sponsor
- French Africa Pediatric Oncology Group
Burkitt Lymphoma
Recommendations for the Treatment of Children With Burkitt's Lymphoma
This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units…
- Trial name
- GFALMB2019 (NCT04425421)
- Testing
- OBSERVATIONAL
- Where
- 7 sites in Burkina Faso, Côte d’Ivoire and 4 more
- Volunteers
- 1,000 people
- Sponsor
- French Africa Pediatric Oncology Group
Nephroblastoma
Therapeutic Recommendations for Nephroblastoma
The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.
- Trial name
- GFANEPHRO20 (NCT04423484)
- Testing
- Data collection
- Where
- 7 sites in Burkina Faso, Côte d’Ivoire and 4 more
- Volunteers
- 1,000 people
- Sponsor
- French Africa Pediatric Oncology Group
Hepatitis B, Vertical Transmission of Infectious Disease
The COMBAT HBV Feasibility Trial
This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC).
- Trial name
- COMBAT-HBV (NCT05705427)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG, Hepatitis B monovalent vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 317 people
- Sponsor
- University of North Carolina, Chapel Hill