SYSTEMS AND METHODS FOR TREATING BACTERIAL INFECTION
Therapeutic methods, kits, dosing regimens and uses of a medicament comprising iclaprim are provided, for example, for the treatment of bacterial infection. The administration of iclaprim in a fixed amount can achieve a Cmax(ss) below about 800 ng/mL, a T>MIC of between about 30% to about 95% and a ratio of AUC/MIC of about 20 to about 85, and the bacterial infection can be treated. The fixed amount can be about 70 mg to about 100 mg. The bacterial infection treated may be caused, or related to, drug-resistant bacteria including S. pneumoniae, H. influenzae, S. aureus, K. pneumoniae and M. catarrhalis . The bacterial infection may manifest as a skin and skin structure infection, pneumonia, asthma, emphysema and/or other adverse pulmonary conditions.
1 . A therapeutic method comprising:
administering to a subject who has a bacterial infection a pharmaceutical composition comprising an amount of iclaprim,
wherein administration of the iclaprim achieves a Cmax(ss) below about 800 ng/mL, a T>MIC of between about 30% to about 95% and a ratio of AUC/MIC of about 20 to about 85, and wherein the bacterial infection is related to respiratory bacterial pathogens.
2 . The therapeutic method of claim 1 , wherein the bacterial infection is caused by drug-resistant bacteria.
3 . The therapeutic method of claim 2 , wherein the bacteria is resistant to methicillin, daptomycin, linezolid or vancomycin.
4 . The therapeutic method of claim 1 , wherein the respiratory pathogens comprise S. pneumoniae, H. influenzae, S. aureus, K. pneumoniae and M. catarrhalis.
5 . The therapeutic method of claim 4 , wherein the pathogen comprises methicillin-resistant S. aureus.
6 . The therapeutic method of claim 1 , wherein the bacterial infection comprises S. aureus lung infections among a cystic fibrosis population.
7 . The therapeutic method of claim 1 , wherein the bacterial infection results in pneumonia.
8 . The therapeutic method of claim 1 , wherein administration of iclaprim comprises intravenous administration or administration via inhalation.
9 . The therapeutic method of claim 1 , wherein the amount of iclaprim is provided in a fixed dose.
10 . The therapeutic method of claim 1 , wherein the fixed amount is about 70 mg to about 100 mg or about 70 mg to about 80 mg.
11 . The therapeutic method of claim 8 , wherein the intravenous administration comprises infusing the pharmaceutical composition into the subject about 1 to about 3 times a day daily.
12 . A dosing regimen comprising:
intravenously administering to a subject who has a bacterial infection a pharmaceutical composition comprising a fixed amount of iclaprim,
wherein administration of the fixed amount achieves a Cmax(ss) below about 800 ng/mL, a T>MIC of between about 30% to about 95% and a ratio of AUC/MIC of about 20 to about 85, and wherein the bacterial infection is related to respiratory bacterial pathogens.
13 . The dosing regimen of claim 12 , wherein the bacterial infection is caused by drug-resistant bacteria.
14 . The dosing regimen of claim 12 , wherein the bacteria is resistant to methicillin, daptomycin, linezolid or vancomycin.
15 . The dosing regimen of claim 12 , wherein the respiratory pathogens comprise S. pneumoniae, H. influenzae, S. aureus, K. pneumoniae and M. catarrhalis.
16 . The dosing regimen of claim 14 , wherein the pathogen comprises methicillin-resistant S. aureus.
17 . The dosing regimen of claim 12 , wherein the bacterial infection comprises S. aureus lung infection among a cystic fibrosis population.
18 . The dosing regimen of claim 12 , wherein the bacterial infection results in pneumonia.
19 . The dosing regimen of claim 12 , wherein the amount of iclaprim is provided in a fixed dose and wherein the fixed amount is about 70 mg to about 100 mg or about 70 mg to about 80 mg.
20 . The dosing regimen of claim 19 , wherein the intravenous administration comprises infusing the pharmaceutical composition into the subject about 1 to about 3 times a day daily.