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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effectiveness and safety of a higher dose of Rifampicin RIF35 compared to the standard dose RIF10 for treating effusive tuberculous pericarditis PCTB. This Phase 2b randomized, placebo-controlled, double-blinded trial aims to see if the higher dose increases Rifampicin exposure in the pericardial fluid and improves mycobacterial clearance. The study involves adults with pericardial TB, and participants are stratified by HIV status and PCF GX-Ultra status before randomization. Participants will receive either the standard anti-tuberculosis treatment alone or with added high-dose Rifampicin orally for 2 months, followed by a 4-month continuation phase with standard doses of Rifampicin and Isoniazid. Dosing is based on WHO weight bands, using fixed dose combination tablets and additional Rifampicin tablets to achieve equitable drug exposure across weights from 30 to 100 kg. Simulations guided the dosing to optimize exposure. During the study, participants will undergo assessments including measuring drug levels in pericardial fluid and mycobacterial load at 72 hours and 52 weeks. Researchers will also monitor mortality, re-accumulation of pericardial effusion, TB-IRIS, constrictive pericarditis, and cardiac magnetic resonance imaging results over 52 weeks. Safety and efficacy will be closely tracked throughout, with total participation covering at least one year.

Age: 18Years +All GendersPhase 2
2 locations
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Actively Recruiting

Healthy Volunteer

Researchers are conducting a nationwide study in South Africa to develop the first nationally representative blood pressure and anthropometric reference values for children aged 5 to under 18 years. This study addresses the lack of appropriate African ancestry data, which currently results in reliance on European and US standards that may not suit the South African paediatric population. The goal is to improve understanding of blood pressure and hypertension in children and to establish clinical guidelines tailored to this population. The study involves measuring blood pressure and body measurements in a randomized sample of approximately 22,464 school-aged children from all provinces and various urban, peri-urban, and rural settings. Data collection will take place over five years, capturing a diverse group representative of South Africas ethnic and socioeconomic backgrounds. These measurements will be used to create nomograms and inform national guidelines for hypertension management in children. Participants will have their blood pressure and anthropometric data collected during the study period. Researchers will analyze these data to determine normal reference values and develop clinical practice guidelines for managing childhood hypertension. The information gathered will also support community engagement and awareness initiatives. The studys findings aim to guide healthcare providers and inform national health policies for better paediatric hypertension care in South Africa.

Age: 5Years - 18YearsAll Genders
11 locations