Clinical trials

This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are: 1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and 2. whether these technologies are feasible and usable in low-resource clinical settings. Participants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.

Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk. Aspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established. This is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.

The goal of this project is to prevent unnecessary deaths due to cervical cancer in Senegal. This mixed methods research responds to identified intrapersonal- and community-level barriers to early cervical cancer screening uptake, follow-up, and treatment among women there. Investigators will apply the Dynamic Adaptation Process (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts in Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes. By studying the process of adaptation of a patient navigation program in a low- and middle-income country (LMIC), investigators will build new knowledge while addressing an important public health issue. The project demonstrates innovation by advancing both adaptation and implementation process knowledge of an evidence-based patient navigation intervention in various contexts within a LMIC with a particular focus on how the adaptation responds to cancer-related stigma, misinformation, and women's autonomy in healthcare decision-making. Investigators will build knowledge through local learning which will further the long-term goal to inform the national cervical cancer prevention and control programs in two areas of Senegal and other similar LMICs.

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. Many people rely on frontline health workers (FHWs) for treatment, but these workers often lack specialized training in skin diseases, making diagnosis difficult. To address this challenge, the SkincAIr project is testing whether a mobile app powered by artificial intelligence (AI) can help FHWs improve their ability to detect Skin NTDs. The study will be conducted in two arms. In the first clinical image data collection arm (36 months), dermatologists in 5 countries (Kenya, Ethiopia, Senegal, Democratic Republic of Congo and Nigeria) will collect images of skin NTD and other skin conditions that will be used for development and training of the AI model within the SkincAIr app before it is tested among FHWs. The second validation study arm will take place in 3 countries (Kenya, Ethiopia and Senegal), and will involve 50 FHWs and around 750 patients in each country over 24 months. During the first 12 months (Phase A), FHWs will diagnose patients using standard methods without the app, establishing baseline performance on key indicators including diagnostic accuracy, time to diagnosis, referral patterns, and cost implications of improved primary-level diagnosis. For the following 6 months (Phase B), FHWs will use the SkincAIr app with AI functionality activated to support diagnosis and enable real-time geolocated disease mapping and hotspot identification. In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills. We will summarize the results using simple numbers and charts to show how often things happen and what the average results look like. Researchers will evaluate how well the app improves diagnosis by FHWs and whether FHWs retain their improved skills even after AI support is removed, by comparing their results with those of a skin specialist (dermatologist). Interviews and group discussions will be recorded, written down, organized into key ideas, and carefully reviewed using a computer program to understand the main themes. Study findings will be shared with National Ministries of Health, presented at local and international conferences, and reported to relevant institutional and regulatory authorities. If successful, this AI tool could boost early detection of skin diseases, enhance disease tracking, and improve healthcare in underserved areas.

The LALGFA2019 Recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (LAL line T and LAL line B with leukocytosis greater than or equal to 50 G/L or in children less than 1 year of age or more than 10 years of age) as well as Endoxan and Methotrexate in high dose consolidation.

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 early implementation of this protocol of therapeutic recommendations for treatment.

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 can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

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.

The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population. Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.

The ToolCAP study aims to see if using ultrasound to look at the lungs when children have symptoms of a lung infection will safely allow doctors to improve how they treat those infections. The study will also look at if it's possible to improve how doctors decide which children need antibiotics. * Lung infections are the most common reason for children to go to the clinic/hospital. * Doctors usually give an antibiotic to every child with a lung infection. * Lung infections can be caused by 2 different types of germs - bacteria or viruses. * Antibiotics only work against bacteria and not against viruses. Lung infections caused by viruses don't need antibiotics as the body fights them by itself. * Lots of research now shows that only 1 in 4 children with a lung infection actually needs an antibiotic, as the rest only have a viral infection causing the symptoms. * This means that 3 in 4 children get an antibiotic when they don't need it. * Taking too many antibiotics can cause problems for children as it can cause diseases like diabetes or asthma. * Nowadays, due to too many people using too many antibiotics, experts are starting to worry that bacteria are starting to become resistant (stronger than the antibiotic). * Ultrasound of the lungs appears to be a way of safely looking at the lungs to see if there is an infection and may help doctors better decide who needs an antibiotic. This study includes children aged 2 months-12 years who come to the hospital with a lung infection. Children who are very unwell or who have already had 2 days of antibiotic treatment will not be allowed to be in the study.

The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A supplementation and the coverage of other child health and nutrition services. In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.

The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients presenting with STEMI and deemed ineligible for the RIC AFRICA RCT because they present \>24 hours from MI onset but less than 72 hours, will be recruited into the observational arm of the study with the same endpoints as the trial. The purpose of the RCT is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated predominantly with thrombolytic therapy.

The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to: * Determine the number of mycetoma cases diagnosed per year and trends over time. * Describe characteristics of diagnosed mycetoma cases. 1. Describe demographic characteristics of patients with mycetoma. 2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time. * Assess etiology of mycetoma cases. * Characterize clinical management of mycetoma cases. 1. Characterize approaches to diagnosis of mycetoma. 2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases. 3. Describe clinical outcomes among patients with mycetoma. The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.