A multicenter study of grepafloxacin and clarithromycin in the treatment of patients with community-acquired pneumonia.

STUDY OBJECTIVES: To compare the efficacies of 10-day regimens of grepafloxacin (GFX) (Raxar or Vaxar; Glaxo Wellcome; Greenford, UK), 600 qd, and clarithromycin (CLA) (Klacid, Biaxin, or Klaracid; Abbott Laboratories; Chicago, IL), 500 mg bid, in patients with community-acquired pneumonia (CAP), on the basis of clinical response, including radiographic evidence, and bacteriologic efficacy. DESIGN: Phase IIIb, double-blind, double-dummy, randomized, prospective, parallel-group, comparative study conducted at 58 centers in 11 countries. PATIENTS AND SETTING: Adult patients with signs and symptoms of CAP that was confirmed by radiographic evidence and who did not require parenteral therapy were included in the study. ASSESSMENTS: Patients were assessed before treatment, during treatment, after treatment, and at follow-up (28 to 35 days after treatment completion). Clinical response was evaluated. Blood and sputum samples were cultured for bacterial pathogens, and serology testing was performed to detect atypical pneumonia. RESULTS: A total of 504 patients were enrolled into the trial: 251 were randomly assigned to receive GFX and 253 to receive CLA. In patients able to be clinically evaluated, clinical success rates at follow-up were 147 of 163 patients (90%) in the GFX group and 148 of 167 patients (89%) in the CLA group (95% confidence interval, -6% to 9%). Pretreatment pathogens were confirmed in 131 of 504 patients (26%), either by culture or serology testing, the primary pathogens being Streptococcus pneumoniae (22%), Haemophilus influenzae (17%), Mycoplasma pneumoniae (25%), and Chlamydia pneumoniae (11%). For patients able to be evaluated who had typical pathogens, bacteriologic success was achieved in 92% of the patients in each treatment group. For patients able to be evaluated who had atypical pathogens, 18 of 18 patients (100%) in the GFX and 23 of 26 patients (88%) in the CLA group had a successful clinical outcome. There were similar rates of adverse events in each group, resulting in

Attendance versus compliance with tuberculosis treatment in an occupational setting--a pilot study.

AIM: To determine the prevalence of non-compliance with tuberculosis treatment at Freegold Mines. OBJECTIVES: 1. To establish the rates of attendance and collection of anti-tuberculosis drugs. 2. To determine prevalence of non-compliance by means of urine tests. DESIGN: A cross-sectional study conducted over 2 weeks at mine medical stations. METHOD: Urine samples were collected from tuberculosis patients 3 hours after drug ingestion. Non-compliance was established by testing these samples for rifampicin and/or isoniazid (INH) metabolites. Non-compliance was defined as a negative urine test result for these drugs in participants whose treatment regimens included one or both. Daily attendance and collection of drugs statistics are recorded in the medical station tuberculosis register. The patient rate of adherence was calculated as the observed number of days on which medication had been collected over the expected treatment days in a given period. RESULTS: Urine test results showed an overall prevalence of non-compliance of 14.6 +/- 3.3%. The study showed that non-compliance with tuberculosis treatment was underestimated by the surveillance data. The rate of non-adherence with treatment established from the formal surveillance procedure was 0.2%. The poor response rate of patients was found to be a major problem and fewer than 40% per day returned to bring urine specimens. The mean prevalences of non-compliance established by rifampicin and INH tests were 19.5 +/- 5.3% and 9.8 +/- 3.9%, respectively, and these were significantly different (Chi 2 = 7.44; P < 0.05). The proportion of false-positive results for INH and rifampicin urine tests were 21% (11/53) and 35% (17/48), respectively, showing that some patients were taking the wrong treatment. CONCLUSIONS: It is clear that attendance at the clinics does not accurately reflect compliance. Both programme compliance (dispensing of the correct treatment) and patient compliance need to be improved. This has important implications for the new national tuberculosis control policy adopted by the South African government that stresses the importance of directly observed therapy, short-course (DOTS) and a patient-centred approach.