Amoxicillin for conjunctivitis

A total enrollment of 212 patients was expected to yield 79 clinically evaluable patients in each treatment group. With 79 patients per treatment group, there was an 80% power to demonstrate equivalence between the 2 treatment regimens (under the assumption of an 87% clinical success rate for both arms, with a significance level of .025). The intent-to-treat population comprised all patients who were randomized and took ?1 dose of study drug. A patient was considered to be clinically evaluable unless he or she (1) had an unconfirmed diagnosis; (2) was lost to follow-up; (3) did not take?1 dose of study drug; (4) had an insufficient course of therapy; (5) received concomitant or post therapy treatment with another effective systemic antimicrobial agent before the assessment that occurred 3–12 days after therapy (but was evaluable if he or she was judged to have experienced clinical failure and if all other evaluability criteria were met); (6) received another effective systemicant imicrobial agent ?24 h before admission and did not experience clinical failure (but was evaluable if he or she received such antimicrobial treatment before admission, if he or she experienced clinical failure, and if all other evaluability criteria were met); (7) returned for the post therapy test-of-cure visit outside the 3–12-day post therapy window (but was evaluable if he or she discontinued study drug because of clinical failure, regardless of the time of any visits, provided that all other evaluability criteria were met); or (8) had other significant protocol violation(s). Patients were considered to be microbiologically evaluable if they were clinically evaluable, if their infection was bacteriologically proven, and if they had an appropriate bacteriologic culture.

For purposes of efficacy analysis, 2-sided 95% CIs around the difference in clinical success rates were generated.

To establish that levofloxacin was at least as effective as the comparator, the upperbound of the confidence interval must have been?15 percentage points. A safety analysis, which included all enrolled patients who took study drug, was done for adverse event data.

A total of 269 patients were enrolled in the study.

The disposition of enrolled patients is shown in figure 1. Ninety-five of 132 patients who received levofloxacin were clinically evaluable, compared with 89 of 137 patients who were treated with the comparator ( figure 1 and table 1).

Disposition of patients in levofloxacin and comparator treatment arms in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia.

a Two patients who were randomized to receive levofloxacin received treatment with the comparator and were analyzed with the comparator group.

b Reasons for premature discontinuation of therapy are shown in table 1.

Disposition of patients in levofloxacin and comparator treatment arms in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia. a Two patients who were randomized to receive levofloxacin received treatment with the comparator and were analyzed with the comparator group.

b Reasons for premature discontinuation of therapy are shown in table 1. Reasons for premature discontinuation of therapy ina

study

Reasons for premature discontinuation of therapy ina study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia. The demographic characteristics of the 2 treatment groups were comparable and are presented in table 2. In general, the demographic and baseline characteristics of the clinically evaluable and intent-to-treat populations were comparable.

Demographic characteristics of participants (intent-to-treat population) in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia. Demographic characteristics of participants (intent-to-treat population) in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia.

Mean APACHE IIscores were comparable for both treatment groups (they were 15.9 for patients in the levofloxacin arm and 16.0 for patients in the comparator arm).

These scores confirmed that buy amoxicillin for human online patients who were entered into the study were seriously ill ( table 3).

APACHE II scores and components of the APACHE II score (for the intent-to-treat population) in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia.

APACHE buy amoxicillin online without a prescription II scores and components of the APACHE II score (for the intent-to-treat population) in a study of the safety and efficacy of levofloxacin for the treatment of community-acquired pneumonia.

The duration of therapy (oral or iv) in the safety-evaluable population (which is the same as an “intent-to-treat” population) was a mean (±SD) of 10.74± 4.29 days for patients treated with levofloxacin and a mean (±SD) of 10.02 ± 4.66 days for patients treated with the comparator.

The median duration of therapy for levofloxacin- and comparator-treated patients was 13.0 and 11.0 days, respectively. The average number of days until the switch from iv to oral therapy in the intent-to-treat population was 4.5 days for the levofloxacin group and 5.1 days for the comparator group. Clinical success was achieved in 89.5% of clinically evaluable patients (85 of 95 patients) treated with levofloxacin

and

In the intent-to-treat population, clinical success was achieved in 72.7% of levofloxacin-treated patients (96 of 132 patients) and in 64.2% of the comparator-treated patients (88 of 137 patients) (95% CI, ?19.9 to 2.9)( table 4).

Overall clinical response forintent-to-treat and clinically evaluable patients in a study of the safety andefficacy of levofloxacin in the treatment of community-acquired pneumonia.

Overall clinical response forintent-to-treat and clinically evaluable patients in a study of the safety andefficacy of levofloxacin in the treatment of community-acquired pneumonia.

Among patients with cultures of respiratory samples that yielded positive results for S. pneumoniae , 86.7% of patients treated with levofloxacin (13 of 15 patients) and 85.0% of patients in the comparator group (17 of 20 patients) demonstrated clinical success. For patients with Haemophilus influenzae , 100% of patients treated with levofloxacin (4 of 4 patients) and 87.5% of patients treated with the comparator (7 of 8 patients) demonstrated clinical success.

pneumoniae , clinical success was demonstrated in 100% of patients in the levofloxacin group (5 of 5 patients) and in 80.0% of patients in the comparator group (8 of 10 patients).

For patients with results of serological testing that were positive for any of the 3 a typical pathogens, 96.0% of patients in the levofloxacin group (24 of 25 patients) and 91.2% of patients in the comparator group (31 of 34 patients) demonstrated clinical success ( table 5).

Clinical response rates, after therapy, for clinically evaluable patients with pathogens of

primary

Among patients with pneumococcal bacteremia at study entry, clinical success was demonstrated in 77.8% of the levofloxacin-treated clinically evaluable patients (7 of 9 patients) and in 77.8% of the comparator-treated clinically evaluable patients (7 of 9 patients). There were no cases confirmed by follow-up culture of persistent pneumococcal bacteremia in either group of patients.

Thirty-eight patients in the clinically evaluable population required mechanical ventilation at study admission because of the severity of their illness. For this group of patients, clinical success was achieved in 84.2% of patients treated with levofloxacin (16 of 19 patients) and in 63.2% of patients treated with the comparator (12 of 19 patients) ( table 6).