This Site and Investigator Spotlight introduces Nsengi Ntamabyaliro, MD, MSc, from the Unit of Clinical Pharmacology and Pharmacovigilance (UPC-PV), University of Kinshasa, in Kinshasa, Democratic Republic of the Congo (DRC). FHI Clinical has worked with Dr. Ntamabyaliro on Phase 3 and 4 trials since 2007, at which time there was a focus on research capacity development in the DRC. Based on this history, FHI Clinical and Dr. Ntamabyaliro are currently collaborating with the UPC-PV on vaccine clinical trials and are working to identify opportunities to keep the research team active at the UPC-PV and the Kinshasa School of Public Health to sustain their research capacity.
Dr. Ntamabyaliro and UPC-PV were spotlighted in August 2022, and all information on this page is current as of then.
About Dr. Ntamabyaliro
Nsengi Ntamabyaliro is a medical doctor who specialized in pharmacoepidemiology and pharmacovigilance. Since 2007 and following his clinical practice in surgery and internal medicine, Dr. Ntamabyaliro has been involved in different roles in many clinical trials: supervisor, site coordinator, co-investigator and principal investigator. His research has focused primarily on malaria but has also included trypanosomiasis, monkeypox and Ebola. Dr. Ntamabyaliro worked as a member of the pharmacovigilance team during the study of EBANGA™, one of the two drugs currently approved by the FDA for the management of Ebola virus disease.
- Determinants of Patients’ Adherence to Malaria Treatment in the Democratic Republic of the Congo. Tropical Medicine and Infectious Disease. July 2022
- Effectiveness of pyronaridine-artesunate against Plasmodium malariae, Plasmodium ovale spp, and mixed-Plasmodium infections: a post-hoc analysis of the CANTAM-Pyramax trial. The Lancet: Microbe. May 2022
- Therapeutic efficacy of artemisinin-based combination therapies in Democratic Republic of the Congo and investigation of molecular markers of antimalarial resistance. The American Journal of Tropical Medicine and Hygiene. September 2021
- Knowledge of antimalarials and health seeking behaviour of households in case of suspected malaria in Democratic Republic of the Congo. Tropical Medicine and Infectious Disease. August 2021
- Pyronaridine-artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study. PLoS Medicine. June 2021
- Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo. Therapeutic Advances in Drug Safety. July 2019
- The European Medicines Agency’s scientific opinion on oral fexinidazole for human African trypanosomiasis. PLoS Neglected Tropical Diseases. June 2019
- Drug use in the management of uncomplicated malaria in public health facilities in the Democratic Republic of the Congo. Malaria Journal. May 2018
About UPC-PV
- Unit of Clinical Pharmacology and Pharmacovigilance (UPC-PV), University of Kinshasa
UPC-PV was created in 2008 with the missions of education, research and service to the nation in the field of clinical pharmacology, rational use of medicines and pharmacovigilance.
UPC-PV was accredited as a National Pharmacovigilance Centre of the DRC in 2009 with the responsibility of ensuring the safety of medicine use and monitoring of adverse drug reactions (ADRs) in the country.
Research interests include:
- Malaria
- Tuberculosis
- HIV
- Sleeping sickness
- Monkeypox
- Ebola virus disease
- COVID-19
UPC-PV networks include:
The research site: Mount Amba Hospital Center
Staff
- Professors
- Medical doctors who are specialists in pharmacoepidemiology, pharmacovigilance, epidemiology, clinical trials, vaccinology, internal medicine, neurology and pediatrics
- Pharmacists
- Lab techs and nurses with 10+ years of clinical trials experience
Primary diseases treated
- Malaria: #1 cause of morbidity in the country and in the area
- Respiratory tract infections
- Diarrhea
- Non-communicable diseases (e.g., cardiovascular diseases)
Recent research
- Phase 4 malaria study: >2500 patients/episodes enrolled from December 2017 to March 2019
- Ongoing research on a COVID-19 vaccine: over 1500 participants enrolled
- Preparation of a clinical trial on a monkeypox drug within the PALM Consortium
Facilities and capabilities
- Two consultation rooms and four 4-bed patient rooms
- Waiting space for 20+ patients
- Nurse’s room
- Air-conditioned laboratory with blood sampling, microscopy, hematology, biochemistry equipment
- Refrigerators: -20°C; -40°C; -80°C
- Air-conditioned pharmacy with refrigerators, freezer, drug storage, thermometers
- Regular calibration of all devices
- Air-conditioned archive room with secure cabinets
- Electricity back-up equipped with automatic on/off
A new site under construction includes:
- 4 consultation rooms
- 4 large bed rooms for patients/participants
- 1 nurse’s room
- 1 large clinical laboratory
- 1 pharmacy
- 6 offices
- 1 meeting room
The disease profile of the DRC
Malaria
The DRC is the second most affected country in the world: 11% of cases and 13% of deaths worldwide.
The DRC has malaria transmission rates of 97%.
Malaria accounts for 52.2% of admissions in the Mont Amba Health District.
Diarrheal diseases
Diarrheal diseases are the 6th ranking cause of death in the DRC.
There has been no significant progress in the reduction of diarrheal diseases for the past 10 years.
Diarrheal diseases account for 3.2% of admissions in the Mont Amba Health District.
Sickle cell disease
25% of the population in DRC have the heterozygote sickle cell trait (carriers).
10-20% of births have the heterozygote sickle cell trait.
2% of births have homozygote sickle cell (sickle cell anemia).
Future research:
- Interventional and non-interventional studies
- Continuing research for malaria, monkeypox and trypanosomiasis
- Bacterial infections
- Diarrheal diseases
- Non-communicable diseases (e.g., diabetes, hypertension)