Safety, effectiveness, and adherence of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger: a study protocol of a pragmatic randomised clinical trial with stratified block randomisation
DiscussionTo increase the feasibility of conducting a RCT, embedded in routine activities of all Niger ’s RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of th e clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-b...
Source: Trials - December 13, 2022 Category: Research Source Type: clinical trials

Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial
DiscussionThe INTENSE-TBM trial represents a key opportunity to enhance TBM treatment with widely available existing drugs notably in high-incidence settings of both TB and HIV. The trial design is pragmatic and the results will permit early and effective applications in TBM patient care, in both HIV and TB high-incidence countries.Trial registrationClinicalTrials.gov NCT04145258. Registered on October 30, 2019. (Source: Trials)
Source: Trials - November 8, 2022 Category: Research Source Type: clinical trials

Linezolid or Vancomycin Surgical Site Infection Prophylaxis
Conditions:   Antibiotic Prophylaxis;   General Surgery Interventions:   Drug: Vancomycin Injection;   Drug: Linezolid Injection Sponsor:   Assistance Publique Hopitaux De Marseille Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 7, 2022 Category: Research Source Type: clinical trials