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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are conducting an observational case-control study to evaluate the effectiveness and safety of the R21Matrix-M vaccine in preventing severe malaria, clinical malaria in high transmission areas, and to assess if vaccinated children have an increased risk of death from any cause. The study focuses on children eligible for the vaccine, comparing vaccinated and unvaccinated groups to understand vaccine impact on malaria and mortality. Cases of severe malaria, clinical malaria, and death will be enrolled along with matched controls based on age and neighborhood. The study is carried out at multiple centers across countries where the R21Matrix-M vaccine is approved and used. Cases are recruited from hospitals, clinics, or the community depending on the condition, while controls are matched from the same neighborhood but different households. For severe malaria and death cases, four controls per case are enrolled, and for clinical malaria cases, there is a one-to-one control ratio. Vaccination status is verified through records or caregiver history. Laboratory tests confirm malaria diagnosis as per specific case definitions. Participants will be children aged 5 months and older living in vaccine deployment areas. Researchers will collect medical and vaccination data, including hospital records and home visits when needed. The study will measure vaccine effectiveness against severe and clinical malaria caused by P. falciparum over about one year and assess the risk of death. Surveillance includes hospital and community case detection, with follow-up data collection from families and healthcare providers. The study aims to provide thorough monitoring of outcomes related to malaria and overall mortality.
Actively Recruiting
Researchers are evaluating whether taking azithromycin as a preventive treatment can reduce the risk of death in adults with advanced HIV disease. This is a Phase 3, double-blind, placebo-controlled trial involving multiple centers. The study aims to understand if azithromycin prophylaxis can lower mortality compared to a placebo in this vulnerable population. Participants will be randomly assigned to receive either an oral azithromycin tablet or a matching placebo tablet once daily for 28 days. After this treatment period, they will be followed for 24 weeks to measure the main outcome of all-cause mortality. The total study participation will last 48 weeks to monitor both short-term and longer-term effects. During the study, participants will undergo assessments to track survival and hospitalizations at 12 and 24 weeks after starting the treatment. Researchers will closely monitor health outcomes and any hospital stays to evaluate the impact of azithromycin prophylaxis. Safety and adherence will be followed throughout the trial to ensure accurate measurement of results.