Table 2.
Characteristics of Published Phase-2 Clinical Trials of Moxifloxacina
| First author of study | Journal | No subjects (% women) | Age | Research focus | Objective | Limiting omission |
|---|---|---|---|---|---|---|
| Bozkurt et al.96 Turkey |
Allergol Immunopathol (2005) |
20 (85.0) |
38.05±14.1 |
Antibiotic hypersensitivity |
To investigate whether MXF can be among the safe alternative antibiotics determined by oral provocation tests for antibiotic intolerant patients |
Enough women, sex was not considered in the design or data analysis |
| Constantinou et al.97 Austalia |
Ophthalmology (2007) |
229 (41.5) |
12.5–98.8 |
Bacterial keratitis |
To determine the clinical efficacy and safety of MXF (1.0%) in patients with bacterial keratitis compared with patients treated with ofloxacin (0.3%) or fortified tobramycin (1.33%)/cephazolin (5%) |
Enough women, sex was not considered in the design or data analysis |
| Vasavada et al.98 India |
J Cataract Refract Surg (2008) |
145 (40.7) |
55–85 |
Cataract surgery |
To evaluate the aqueous concentration of MXF following two dosing regimens of topically administered MXF hydrochloride ophthalmic solution 0.5% |
Enough women, sex was not considered in the design or data analysis |
| Katz et al.99 USA |
Cornea (2005) |
61 (50) |
48–85 |
Cataract surgery |
To investigate the absorption of MXF into human aqueous humor after administration of MXF hydrochloride ophthalmic solution, 0.5% as base |
Enough women, sex was not considered in the design or data analysis |
| Lane et al.100 USA |
J Cataract Refract Surg |
47 (59.6) |
51–88 |
Cataract surgery |
To evaluate posterior and anterior segment safety of an intracameral injection of MXF 0.5% ophthalmic solution as prophylaxis for endophthalmitis in patients having cataract surgery |
Enough women, sex was not considered in the design or data analysis |
| Ong-Tone et al.101 Canada |
J Cataract Refract Surg (2007) |
100 (65) |
49–90 |
Cataract surgery |
To determine whether the penetration into the aqueous humor of gatifloxacin and MXF eye drops was affected by altering their concentrations in the dilating mixture in which the wick used to dilate the pupil before cataract surgery was soaked |
Enough women, sex was not considered in the design or data analysis |
| Diz Dios et al.102 Spain |
Antimicrob Agents Chemother (2006) |
221 (43) |
18–57 |
Dental extraction |
To investigate the efficacies of the prophylactic administration of amoxicillin, clindamycin, and MXF for the prevention of bacteremia following dental extractions |
Enough women, sex was not considered in the design or data analysis |
| DeRamo et al.103 USA |
Am J Ophthalmol (2006) |
42 (57) |
49–93 |
Endophthalmitis |
To study the use of gatifloxacin and MXF, and bacterial sensitivity in cases of acute postoperative endophthalmitis following cataract surgery |
Enough women, sex was not considered in the design or data analysis |
| Beyer et al.104 USA |
Eur J Clin Microbiol Infect Dis (2000) |
12 (0) |
24–40 |
Healthy |
To investigate the effect of a 7-day treatment with MXF (400 mg orally, once daily) versus clarithromycin (500 mg orally, twice daily) on the normal oropharyngeal microflora |
Did not include women |
| Man et al.105 United Kingdom |
J Antimicrob Chemother (1999) |
32 (0) |
18–45 |
Healthy |
To assess the potential of MXF to induce phototoxicity when compared with lomefloxacin and placebo |
Did not include women |
| He et al.106 USA |
J Cataract Refract Surg (2009) |
120 (50) |
24–93 |
Healthy |
To compare selection for fluoroquinolone-resistant bacteria between 1-day and 3-day application of topical MXF 0.5% |
Enough women, sex was not considered in the design or data analysis |
| Sebban et al.107 France |
Support Care Cancer (2008) |
90 (68.9) |
21–80 |
Healthy |
To evaluate MXF use in cancer patients with febrile neutropenia |
Enough women, sex was not considered in the design or data analysis |
| Cheon et al.108 Korea |
Helicobacter (2006) |
85 (44.7) |
54.3±11.7 |
H. pylori infection |
To evaluate the efficacy and tolerability of MXF-based triple therapy as an alternative second-line treatment for H. pylori infection |
Enough women, sex was not considered in the design or data analysis |
| Kilic et al.109 Turkey |
Dig Dis Sci (2008) |
120 (47.5) |
>18 |
H. pylori infection |
To evaluate the efficacy of MXF-containing regimens in the first-line treatment of H. pylori |
Enough women, sex was not considered in the design or data analysis |
| Bago et al.110 Croatia |
Wien Klin Wochenschr (2007) |
276 (48.2) |
48±13 |
H. pylori infection |
To prove the efficacy and tolerability of MXF-based treatment of H. pylori infection and to compare it with standard clarithromycin-based treatments |
Enough women, sex was not considered in the design or data analysis |
| Miehlke et al.111 Germany |
Helicobacter (2008) |
103 (65) |
21–79 |
H. pylori infection |
To investigate a 1-week once-daily triple therapy with esomeprazole, MXF, and rifabutin for rescue therapy of H. pylori infection |
Even though there are enough women, sex was not included in the design or analysis |
| Ta et al.112 USA |
J Ocul Pharmacol (2008) |
60 (31.7) |
69.3 |
Intraocular surgery |
To compare the efficacy of a 1-hour versus 1-day application of topical MXF in eliminating conjunctival bacterial flora |
Sex not included in the design Not enough women |
| Pardillo et al.113 Philippines |
Antimicrob Agents Chemother (2008) |
8 (0) |
22–49 |
Leprosy |
To evaluate bactericidal activity of MXF in human leprosy |
Did not include women |
| Schwab et al.114 Germany |
Aliment Pharmacol Ther (2005) |
20 (25.0) |
53.9±12.5 |
Obstructive cholangitis and the non-obstructed biliary tract |
To establish the secretion of MXF into obstructed and non-obstructed bile |
Sex not included in the design Not enough women |
| Hollan et al.115 USA |
Cornea (2008) |
50 (56.0) |
20–87 |
Penetrating keratoplasty |
To examine the ocular penetration of MXF |
Enough women, sex was not considered in the design or data analysis |
| Guentsch et al.116 Germany |
J Periodontol (2008) |
92 (52.2) |
49.6±9.4 |
Periodontitis |
To evaluate the impact of adjunctive systemic MXF compared to the use of adjunctive systemic doxycycline, well-established regimen, and scaling and root planning alone on the success of periodontitis treatment |
Enough women, sex was not considered in the design or data analysis |
| Burka et al.117 USA |
Am J Ophthalmol (2005) |
40 (45.0) |
21–47 |
Photorefractive keratectomy |
To compare the rate of epithelial healing following photorefractive keratectomy with gatifloxacin and MXF |
Enough women, sex was not considered in the design or data analysis |
| Moshirfar et al.118 USA |
Cornea (2005) |
46 (50.0) |
12–86 |
Photorefractive keratectomy |
To compare the effects of topical MXF and gatifloxacin on corneal reepithelialization after penetrating keratoplasty |
Enough women, sex was not considered in the design or data analysis |
| Jardim et al.119 Mexico, Chile, Brazil, Argentina, Uruguay |
Arch Bronconeumol (2003) |
84 (48.8) |
>18 |
Pneumonia |
To evaluate the efficacy and safety of treatment with either MXF or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection |
Even though there are enough women, sex was not included in the design or analysis |
| Ott et al.120 Germany |
Infection (2008) |
96 (27.1) |
37±14 |
Pneumonia and primary lung abscess |
To compare MXF and ampicillin/sulbactam concerning efficacy and safety in the treatment of aspiration pneumonia and primary lung abscess |
Sex variable not included in the design Not enough women |
| Campos et al.121 Brazil |
Clin Ophthalmol (2008) |
61 (72.1) |
29.1 |
Prophylaxis after LASIK |
To compare the efficacy and tolerability of a fixed-dose combination of 0.5% MXF and 0.1% dexamethasone formulation versus conventional dosing with both agents dosed separately for prophylaxis after laser-assisted in situ keratomileusis |
Women are majority, sex was not included in the design and the analysis |
| Gosling et al.122 Tanzania |
J Respir Crit Care Med (2003) |
43 (14.0) |
18–70 |
Tuberculosis |
To compare the relative activity of the drugs with control regimens examined at the same time and with historic controls. In this paper, the results of a trial comparing MXF with rifampin and isoniazid are reported |
Sex not included in the design Not enough women |
| Pletz et al.123 Germany |
Antimicrob Agents Chemother (2004) |
17 (29.4) |
50.4±8.7 |
Tuberculosis |
To assess the potency of new antituberculous drugs in clinical studies |
Sex not included in the design Not enough women |
| Burman et al.124 USA |
Am J Respir Crit Care Med (2006) |
277 (32.9) |
24–40 |
Tuberculosis |
To compare the impact of MXF versus ethambutol, both in combination with isoniazid, rifampin, and pyrazinamide, on sputum culture conversion at 2 months as a measure of the potential sterilizing activity of alternate induction regimens |
Even sex analysis was performed, sex not included in the design |
| Conde et al.125 Brazil |
Lancet (2009) | 146 (38.4) | 32.5 (11.7) | Tuberculosis | To assess the activity and safety of MXF in the initial stage of tuberculosis treatment | Even sex analysis was performed, sex not included in the design |
a
Ordered by research focus and percentage of women participating in the clinical trials.
Objective of phase-2 clinical trials: the experimental treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
CAP, community acquired pneumonia.