Table 4.
Characteristics of Published Phase-4 Clinical Trials of Moxifloxacina
First author | Journal | No. subjects (% women) | Age | Research focus | Objective | Limiting omission |
---|---|---|---|---|---|---|
Grassi et al.175 USA |
J Chemother (2002) |
423 (21.3) |
69.3±8.4 |
AECB |
To compare the efficacy and tolerability of a 5-day treatment course with oral MXF vs a 7-day course with intramuscular ceftriaxone in 476 patients with acute exacerbations of chronic bronchitis, and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service and society |
Sex not included in the design Not enough women |
Miratvilles et al.176 Spain |
Int J Clin Pract (2001) |
5,736 (35.4) |
66 |
AECB |
To examine the clinical effect of oral MXF on patients' signs and symptoms of AECB |
Sex not included in the design Not enough women |
Lorenz et al.177 USA |
J Int Med Res (2001) |
332 (46.1) |
16–93 |
AECB |
To compare with the macrolides azithromycin, clarithromycin and roxithromycin in a cohort study to assess clinical, safety, and health-related outcomes of these antimicrobials in general practice settings |
Enough women, sex was not considered in the design or data analysis |
Koch et al.178 USA |
Clin Drug Investig (2004) |
1,146 (47.3) |
54.3±18.2 |
CAP |
To assess the efficacy, safety and tolerability of oral MXF in outpatients with respiratory tract infections treated in general practices in Germany with the focus on CAP |
Sex analysis was performed Sex not considered in the design |
Landen et al.179 Germany |
J Int Med Res (2001) |
15,959 (48.7) |
14–60 |
CAP |
To study of the speed, efficacy and tolerability of MXF when used in clinical practice for the treatment of CAP or AECB |
Enough women, sex was not considered in the design or data analysis |
Barth et al.180 Germany |
Clinical Drug Investigation (2005) |
1,749 (43.5) |
43.4±14.3 |
Pneumonia |
To investigate the efficacy, safety, and tolerability of sequential i.v./o.p. therapy with MXF in pneumonia under general hospital treatment conditions. |
Enough women, sex was not considered in the design or data analysis |
Liu et al.181 China |
Int J Clin Pract (2007) |
3,184 (41.0) |
20–79 |
Respiratory tract infections |
To assess the efficacy and tolerability of MXF post marketing |
Sex analysis performed Sex not considered in the design. |
Chen et al.182 China |
Clin Drug Investig (2006) |
855 (41.1) |
50.4±18.5 |
Respiratory tract infections |
To assess the efficacy, safety and tolerability of oral MXF in patients with respiratory tract infections treated by attending physicians in routine clinical practice in China |
Sex analysis performed Sex not considered in the design |
Faich et al.183 USA |
Ann Pharmacother (2004) |
18,299 (61.9) |
6–97 |
Respiratory tract infections |
To further investigate MXF's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study |
Enough women, sex was not considered in the design or data analysis |
Elies et al.184 Germany |
Clin Drug Investig (2004) | 2,405 (56.8) | 43.4±14.3 | Sinusitis | To assess the efficacy, safety and tolerability of MXF in patients with respiratory tract infections treated in general practice in Germany | Enough women, sex was not considered in the design or data analysis |
Ordered by research focus and percentage of women participating in the clinical trials.
Phase 4: postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.