Kinshasa

Researchers are evaluating the safety, side effects, and immune response after one and two doses of the mRNA vaccine candidate BNT166a compared to a placebo in healthy adults. This randomized, double-blind, placebo-controlled Phase II trial includes two groups adults aged 18 to 45 years who have never had Orthopoxvirus exposure and adults aged 18 to 64 years who have previous Orthopoxvirus exposure. Participants receive two doses of BNT166a vaccine or placebo injections into the deltoid muscle, spaced at least 28 days apart. The study includes Cohort 1 Orthopoxvirus-nave adults 18-45 years and Cohort 2 Orthopoxvirus-experienced adults 18-64 years. The total study duration for each participant is approximately 14 months. During the study, participants will be closely monitored for local and systemic reactions for up to 7 days after each dose and for adverse events up to 14 months. Researchers will measure immune responses through antibody levels at baseline and one month after each dose. Safety assessments include tracking serious and medically attended adverse events, as well as any events causing withdrawal. Participants will have scheduled visits and assessments throughout the study to evaluate these outcomes.

Researchers are evaluating the effects of antibiotic treatment on asymptomatic bacteriuria AB during pregnancy in low- and middle-income countries. This phase 3 randomized controlled trial aims to reduce the incidence of small vulnerable newborns SVN and stillbirths SB, contributing to global health goals to prevent early childhood deaths. The study involves pregnant individuals and newborns across seven international sites collaborating with the NICHD Global Network for Womens and Childrens Health Research. Participants with AB are randomly assigned to one of two groups one group receives a 7-day course of oral nitrofurantoin monohydratemacrocrystals at 100 mg twice daily 14 doses total, while the other group receives a matching placebo on the same schedule. The study compares the impact of this antibiotic treatment versus placebo during pregnancy. During the study, participants will complete screening, randomization, treatment, and follow-up visits, with monitoring continuing until 42 days after birth. Researchers will assess the number of small vulnerable newborns or stillbirths as the main outcome. Participants must remain in the study area for the full postpartum follow-up period, during which health and safety are monitored carefully.

This trial evaluates oral caffeine treatment compared to placebo in newborns diagnosed with moderate to severe hypoxic ischemic encephalopathy HIE, a brain injury caused by lack of oxygen around birth. The study aims to reduce death or serious neurodevelopmental problems by 18 to 22 months of age. HIE is usually treated with cooling therapy, but this study explores caffeine as a potentially beneficial and low-cost alternative. Newborns at least 36 weeks gestation and weighing 1800 grams or more, diagnosed within six hours after birth, are randomly assigned to receive either caffeine or placebo. The caffeine group receives one 20 mgkg dose followed by two 10 mgkg doses at 24-hour intervals by mouth or feeding tube. The placebo group receives identical doses without caffeine. Sub-studies include blood sampling for caffeine levels, brain imaging with MRI, and cord blood collection for molecular analysis. Participants undergo assessments during hospitalization and follow-up visits up to 18 to 22 months old. Researchers measure survival and neurodevelopmental outcomes using physical exams, developmental tests, neurological scales, growth measures, and kidney function tests. Safety is monitored closely, and serious adverse events are recorded. The total study duration extends until final outcome assessments at nearly two years of age.

Researchers are investigating febrile illnesses in the Democratic Republic of Congo DRC, focusing on their causes, clinical features, and outcomes. This study builds on the previous FIKIb2 study, which examined fever-related diseases and the use of inflammatory markers like C-reactive protein CRP to manage antibiotic use better. It aims to assess the impact of CRP testing, the WHOs AWARE antibiotic guidance, and electronic decision tools on antibiotic prescribing in primary care settings, while also strengthening research capacity and biobanking in the region. The study is observational and involves multiple centers, starting with pediatric emergency and outpatient departments. It recruits adults and children presenting with fever, collecting clinical and laboratory data at the initial visit and during a three-week follow-up. Laboratory samples are stored for further research, including blood cultures and testing for viral infections like arboviruses. The study uses systematic clinical assessment, biomarker measurement, and surveillance tools to deepen understanding and improve management of febrile illnesses. Participants will undergo blood tests for CRP, white blood cell counts, malaria detection, and other routine labs. Data on symptoms, clinical presentation, and treatment adherence are collected at enrollment and through follow-up visits on days 7, 14, and 21. Researchers will analyze antibiotic use, illness severity, hospital admissions, and outcomes, aiming to improve fever management and reduce inappropriate antibiotic use across study sites. The total participation lasts approximately three weeks with continued monitoring during this period.

Researchers are studying children under the age of 5 living in the Kisantu Health Zone of the Democratic Republic of Congo to understand how malaria vaccination affects the risk of invasive non-typhoidal Salmonella iNTS disease. This observational study aims to compare the malaria vaccination status of children with and without iNTS infection to see if the malaria vaccine offers protection against this serious bacterial infection. The study uses a case-control design to analyze these relationships. The intervention under study is the R21Matrix-M malaria vaccine, which was introduced in the Expanded Program on Immunizations on October 29, 2024. Children between 6 and 24 months old are eligible for vaccination, which includes four doses the first dose between 6 and 11 months of age, followed by a second dose one month later, a third dose one month after that, and a booster dose seven months after the third dose. Participants are grouped based on their vaccination status, including those who received all four doses, partial doses, or no vaccination. Participants presenting with fever at healthcare facilities are tested for malaria and iNTS using blood cultures, microscopic blood smears, rapid diagnostic tests, and PCR for confirmation. Those diagnosed with iNTS andor malaria receive treatment according to national guidelines and are monitored until recovery or up to 21 days after enrollment. The study measures include confirmed iNTS infection rates in vaccinated versus unvaccinated children and the severity of infections. Follow-up assessments track disease outcomes and resolution of symptoms.

Researchers are studying how monkeypox mpox spreads in the Democratic Republic of Congo DRC, how it affects different groups of people, and how well vaccines protect against it. This observational study uses a cross-sectional survey design, collecting data from patients diagnosed with mpox at one point in time, and a case-control approach comparing those who test positive to those who test negative to find risk factors and vaccine effectiveness. The study is conducted by the Institut National de Recherche Biomdicale and international partners, focusing on provinces heavily affected by mpox outbreaks. Participants with suspected mpox who visit hospitals or health centers for testing will be invited to join the study. They will answer questions about symptoms, medical history, exposure to the virus, and vaccination status. Biological samples such as blood, throat swabs, and skin lesion swabs will be collected to test for mpox and other infections like measles or chickenpox. Hospitalized patients will have additional data recorded about their recovery. During the study, researchers will collect clinical and sociodemographic information, exposure factors, and transmission modes of mpox. They will compare infection rates between vaccinated and unvaccinated people and examine differences between two virus types. The study also tracks co-infections and risk factors for severe disease or death. Data will help train healthcare workers and improve real-time sharing on an online platform. The study will run for two years, assessing many health and transmission outcomes related to mpox.

Researchers are estimating the prevalence of high-risk human papillomavirus HR HPV infections among girls and women aged 9 to 50 years across eight countries in South Asia and sub-Saharan Africa. This study aims to understand HPV infection rates in low socio-economic populations and specific sub-groups, including sexually active young women, by conducting cross-sectional surveys and longitudinal studies. Additionally, qualitative sub-studies will explore how gender norms and stigma affect HPV burden and access to prevention and treatment services. The study uses a harmonized protocol across all participating countries with country-specific adaptations. Cross-sectional surveys will collect urine samples from girls and women in urban and rural areas to estimate HPV prevalence. Longitudinal studies will follow sexually active girls and women aged 15 to 35 years over 24 months, collecting vaginal swabs and urine samples to measure persistent HPV infection. Qualitative studies will include interviews and focus groups to understand social factors influencing HPV risks and healthcare access. Participants will provide samples and answer standardized questionnaires on demographics, sexual and reproductive history, HPV vaccination, cervical cancer screening, and related attitudes. Testing will occur at enrollment and every six months for two years in longitudinal studies. Researchers will monitor HPV infection rates, assess questionnaire responses, and analyze laboratory results. The study includes safety follow-up and detailed data collection to provide comprehensive insight into HPV prevalence, incidence, and social influences in these populations.

This registry collects detailed information about children diagnosed with cancer who are treated in pediatric oncology units affiliated with the French African Oncology Group in French-speaking Africa. Its goal is to gather data on patient numbers, cancer stage, treatments received, and outcomes to support better planning and delivery of pediatric oncology care in the region. The registry aims to provide valuable insights for local and national health authorities to improve pediatric cancer programs. Children and adolescents under 18 years old who present at participating pediatric oncology units and have any type of cancer are included in this observational registry. Data collected includes demographic information, socioeconomic status, clinical details, treatment status, vital status, treatment abandonment, and loss to follow-up. The information is entered online using the REDCap system and securely stored by the IT department at Gustave ROUSSY in Paris. Participants information is gathered continuously during their treatment and follow-up at the hospital units. The main measures tracked include the number of children suspected of having cancer within 12-month periods, their vital status, illness status, and treatment status. This ongoing data collection helps monitor outcomes and supports healthcare planning. Participation involves no experimental treatment and is focused on data recording and observation over time.

Arboviral diseases, spread by Aedes mosquitoes, are a growing public health concern worldwide, especially in Africa where data is limited. In the Democratic Republic of the Congo, including Kinshasa, outbreaks of yellow fever, dengue, chikungunya, and Zika have occurred, with transmission levels exceeding World Health Organization standards. This research aims to test and evaluate various methods to control Aedes mosquitoes at different life stages in Kinshasa to better understand and reduce the spread of these diseases. The study is a before-and-after interventional trial conducted in the Mont Ngafula 1 health zone of Kinshasa. It includes four groups one practicing community-based environmental management alone, one combining this with larvicidal control targeting immature mosquitoes using pyriproxifen-based stations, one combining environmental management with adult mosquito control using mass trapping with BG-GAT traps, and a control group without interventions. Each group involves 400 households, with interventions lasting 12 months. Entomological surveys are carried out in a subset of households before, during, and after the interventions to measure mosquito density and viral presence. Participants will also take part in a serological survey for arboviral diseases and complete questionnaires assessing knowledge and practices related to mosquito control before and after interventions. The study measures include mosquito collection counts, larval surveys, and epidemiological indicators, with safety and progress monitored throughout. Data collected will help evaluate the feasibility and impact of these vector control strategies and improve understanding of disease exposure and community awareness in the area.

Researchers are studying pregnancy outcomes in low-resource geographic areas to understand trends in stillbirths, neonatal deaths, and maternal mortality over time. This observational study aims to provide accurate population-based data to improve health outcomes for women and children in regions with limited healthcare systems and poor birth and death records. The study also includes a sub-study to explore COVID-19 prevalence among pregnant women and its impact on pregnancy outcomes. The study involves pregnant women in defined community clusters who intend to deliver within these areas or who deliver there, including those transferred for care at delivery. Participants in the COVID-19 sub-study provide a blood specimen at or near delivery to test for COVID-19 antibodies. Some sites also collect blood samples during antenatal visits. No treatment intervention is given this is a registry and observational data collection study. Participants provide data through ongoing registry systems that track maternal and newborn health outcomes, including mortality rates up to 42 days after delivery and neonatal outcomes up to 28 days. Researchers collect information on causes of death, COVID-19 antibody status, and maternal mental health. The study continues over years to support public health policy development and evaluate interventions. Participation involves data collection without direct treatment, and the study will monitor outcomes through follow-up visits and specimen testing.