Nutritional treatment of children 6 –59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial
This study will address whether children with WAZ< −3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol.MethodsThis is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6 –59 months presenting with MUAC ≥125 mm and WAZ< −3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥−3 for 2 visits, (3) standard treatment receiving R...
Source: Trials - January 8, 2024 Category: Research Source Type: clinical trials
Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
AbstractThis manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal...
Source: Trials - November 29, 2023 Category: Research Source Type: clinical trials
Statistical analysis plan for the LAKANA trial: a cluster-randomized, placebo-controlled, double-blinded, parallel group, three-arm clinical trial testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1 –11-month-old infants in Mali
ConclusionThe SAP written prior to data collection completion will help avoid reporting bias and data-driven analysis for the primary and secondary aims of the trial. If there are deviations from the analysis methods described here, they will be described and justified in the publications of the trial results.Trial registrationClinicalTrials.gov IDNCT04424511. Registered on 11 June 2020. (Source: Trials)
Source: Trials - November 15, 2023 Category: Research Source Type: clinical trials
Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali
Conditions: Healthy Women of Child Bearing Potential Interventions: Biological: R21/Matrix-M1; Biological: Saline and R21/Matrix-M1; Other: Sterile isotonic (0.9%) normal saline Sponsors: European Vaccine Initiative; University of Oxford; Malaria Research and Training Center, Bamako, Mali Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 12, 2023 Category: Research Source Type: clinical trials
Enterics for Global Health (EFGH)
Conditions: Shigella; Child; Diarrhea Intervention: Sponsors: University of Washington; Aga Khan University; International Centre for Diarrhoeal Disease Research, Bangladesh; University of Maryland, Baltimore; University of Virginia; Asociacion Benefica Prisma; Medical Research Council Unit, The Gambia; Kenya Medical Research Institute; Center for Vaccine Development - Mali; Malawi-Liverpool-Wellcome Trust Clinical Research Programme; Bill and Melinda Gates Foundation Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 21, 2023 Category: Research Source Type: clinical trials
Enterics for Global Health (EFGH)
Conditions: Shigella; Child; Diarrhea Sponsors: University of Washington; Aga Khan University; International Centre for Diarrhoeal Disease Research, Bangladesh; University of Maryland, Baltimore; University of Virginia; Asociacion Benefica Prisma; Medical Research Council Unit, The Gambia; Kenya Medical Research Institute; Center for Vaccine Development - Mali; Malawi-Liverpool-Wellcome Trust Clinical Research Programme; Bill and Melinda Gates Foundation Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 21, 2023 Category: Research Source Type: clinical trials
hands4health: A Multi-component Intervention on Hand Hygiene in Primary Health Care Facilities in Burkina Faso and Mali
Conditions: Hand Hygiene Behavior; Hand Hygiene Effectiveness Intervention: Other: Multi-component hand hygiene intervention in primary health care facilities Sponsors: Swiss Tropical & Public Health Institute; Terre des Hommes; University of Applied Sciences and Arts Northwestern Switzerland Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 14, 2023 Category: Research Source Type: clinical trials
