scholarly journals Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial

2014 ◽  
Vol 69 (8) ◽  
pp. 2246-2251 ◽  
Author(s):  
J. Kalita ◽  
U. K. Misra ◽  
S. Prasad ◽  
S. K. Bhoi
Keyword(s):  
Randomized Controlled Trial ◽  
Tuberculous Meningitis ◽  
Controlled Trial ◽  
Open Label ◽  
Safety And Efficacy ◽  
Randomized Controlled

Standard versus sequential anti-tubercular treatment in patients with tuberculous meningitis: a randomized controlled trial

2020 ◽  
Author(s):  
Usha Kant Misra ◽  
Mritunjai Kumar ◽  
Jayantee Kalita
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Mortality ◽  
Tuberculous Meningitis ◽  
Controlled Trial ◽  
Hospital Death ◽  
Inclusion Criteria ◽  
Open Label ◽  
Drug Induced ◽  
Standard Regimen ◽  
Randomized Controlled

Abstract Background To compare the safety and efficacy of sequential anti-tubercular treatment (ATT) regimen with the standard regimen in tuberculous meningitis (TBM). Methods This single-centre, open-label, parallel group randomized controlled trial was conducted from May 2017 to June 2019 in India. Treatment-naïve patients with TBM fulfilling the inclusion criteria were randomized to four drug ATT regimens (rifampicin, isoniazid, ethambutol and pyrazinamide) administered either simultaneously (standard arm) or one after another (sequential arm) in a 1 : 1 ratio. The primary endpoint was drug-induced hepatitis (DIH) and the secondary endpoints were in-hospital death and disability at 3 and 6 months using a modified Rankin Scale. Results A total of 97 patients with TBM were recruited; 15 did not meet the inclusion criteria and 2 refused to participate. The median age of the patients was 26 y (range 15–75) and 37 (46.2%) were males. The patients in the sequential arm had fewer cases of DIH (20% vs 42.5%; p=0.03). The patients in the sequential arm had lower in-hospital mortality (2.5% vs 17.5%; p=0.025) and better 6-month outcomes (25.0% vs 50.0%; p=0.02) compared with the standard arm. Conclusions Sequential ATT was associated with a lower frequency of DIH, lower in-hospital mortality and better 6-month outcome. Trial registration Clinical Trials Registry of India (ctri.nic.in) identifier: REF/2016/09/012214/CTRI/2017/10/010072.

scholarly journals Randomized Controlled Trial of the Safety and Efficacy of Daptomycin versus Standard-of-Care Therapy for Management of Patients with Osteomyelitis Associated with Prosthetic Devices Undergoing Two-Stage Revision Arthroplasty

2012 ◽  
Vol 56 (11) ◽  
pp. 5626-5632 ◽  
Author(s):  
Ivor Byren ◽  
Shruta Rege ◽  
Ed Campanaro ◽  
Sara Yankelev ◽  
Diane Anastasiou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Success ◽  
Controlled Trial ◽  
Joint Infection ◽  
Revision Arthroplasty ◽  
Standard Of Care ◽  
Primary Objective ◽  
Open Label ◽  
Safety And Efficacy ◽  
Randomized Controlled

ABSTRACTThe prevalence ofStaphylococcus aureuscausing prosthetic joint infection (PJI) supports investigation of higher doses of daptomycin in the management of PJI. This was a prospective, randomized controlled trial studying safety and efficacy of daptomycin (6 and 8 mg/kg of body weight) compared with standard-of-care therapy for PJI. This open-label study randomized 75 patients undergoing 2-stage revision arthroplasty to daptomycin at 6 or 8 mg/kg or a comparator (vancomycin, teicoplanin, or semisynthetic penicillin). After prosthesis removal, patients received 6 weeks of antibiotic treatment and a 2- to 6-week antibiotic-free period before implantation of a new prosthesis. Test of cure (TOC) was within 1 to 2 weeks after reimplantation. The primary objective was evaluation of creatine phosphokinase (CPK) levels. Secondary objectives were clinical efficacy and microbiological assessments. Of 73 CPK safety population patients, CPK elevation of >500 U/liter occurred in 4 of 25 (16.0%) (daptomycin, 6 mg/kg) and 5 of 23 (21.7%) (daptomycin, 8 mg/kg) daptomycin-treated patients and 2 of 25 (8.0%) comparator patients. Adverse-event rates were similar among daptomycin and comparator groups. Among modified intent-to-treat patients at TOC, clinical success rates were 14 of 24 (58.3%) for 6 mg/kg daptomycin, 14 of 23 (60.9%) for 8 mg/kg daptomycin, and 8 of 21 (38.1%) for the comparator. Overall microbiological success at TOC was 12 of 24 (50.0%) for 6 mg/kg daptomycin, 12 of 23 (52.2%) for 8 mg/kg daptomycin, and 8 of 21 (38.1%) for comparator patients. In conclusion, daptomycin at 6 and 8 mg/kg given for up to 6 weeks was safe and appeared to be effective in managing staphylococcal PJI using a 2-stage revision arthroplasty technique in a total of 49 patients.

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