Search Bar & Filters
Found 3 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effects of azithromycin mass drug administration (MDA) on child survival and antimicrobial resistance (AMR) in Niger through the AVENIR II adaptive platform trial. This study focuses on monitoring under-5 mortality rates and the development of resistance to macrolide antibiotics as the azithromycin MDA program expands nationwide. The trial aims to track mortality against Sustainable Development Goal targets and assess the continued effectiveness and risks of the intervention over time. Azithromycin will be given as a single oral suspension dose to children, with dosing based on age or height. Administration uses dosing cups or syringes, with doses rounded up for very young children who cannot drink from cups. The study includes repeated monitoring and re-randomization every two years to adapt the evaluation according to ongoing results. Participants will be monitored for mortality and AMR over periods of 2 and 4 years using nasopharyngeal and rectal swabs to measure resistance levels. The trial involves community and individual-level assessments, with verbal approval required from community leaders, participants, or caregivers. Researchers will measure all-cause mortality and genetic markers of resistance, carefully balancing safety and long-term outcomes throughout the program.
Actively Recruiting
Researchers are collecting detailed information about children with cancer who are treated at pediatric oncology units in French-speaking Africa. This registry aims to provide accurate data on the number of cases, disease stage, treatments, and outcomes to help improve pediatric cancer care and support local and national health planning. The project focuses on children and adolescents under 18 years old diagnosed with any type of cancer. The data includes demographic and socioeconomic details along with clinical status and treatment results. Information on vital status, treatment abandonment, and loss to follow-up is also gathered. Data is entered locally into an online system called REDCap and securely stored by the IT department at Gustave ROUSSY in Paris-Villejuif. Participants are children under 18 who come to participating hospitals for cancer treatment. Researchers track the number of children suspected of having cancer, their health status, treatment progress, and survival over any 12-month period. This ongoing registry helps monitor outcomes and supports efforts to improve pediatric oncology services in the region.
Actively Recruiting
Researchers are evaluating a new high-dose tuberculosis retreatment regimen to see if it is as safe as the regular dose in patients previously treated for rifampicin-susceptible recurrent tuberculosis. This Phase 3 clinical trial also aims to understand the bacterial effectiveness and the development of drug resistance during treatment. The study is conducted in clinics supported by the Damien Foundation in Niger, focusing on overcoming resistance without creating more. The trial has two stages. In Stage 1, participants are randomly assigned to either the control group receiving the standard 6-month treatment regimen (6EHRZ) or the intervention group receiving a triple-dose version of the same drugs (6EH³R³Z). If interim results show the high-dose regimen is not non-inferior in safety, the intervention is adjusted while continuing comparison with the control. In Stage 2, the study continues as an observational cohort using only the control regimen due to safety concerns. Participants have daily contact with a therapy supervisor and monthly clinic visits for safety and treatment monitoring. Liver function tests are done at set intervals during treatment. After treatment completion, participants are followed up at six months and one year to check for relapse through sputum tests and cultures. The main outcomes measured include the number of serious adverse events related to treatment, bacterial response, and acquired drug resistance over 18 months.