Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
InfectionsBacterialThis is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin...
UreaplasmaBacterial InfectionThe purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies.
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients...
Bacterial InfectionsIntra-Abdominal Infection6 moreTo determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated...
Bacterial InfectionsThe purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322...
InfectionsBacterialThis study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects. The study will also include a P450 probe drug (midazolam) to evaluate the effect of GSK1322322 to inhibit or induce CYP3A4 substrates.
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial...
Gram-negative Bacterial InfectionThe purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Bacterial Infections and MycosesAppendicitis3 moreThe purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.
Leukocyte Depletion of Autologous Whole Blood
InfectionBacterial Infection1 moreLeukocyte depletion of autologous whole blood prior to storage does not reduce infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion rate
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S....
PneumoniaPneumococcal2 moreThis study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms...
Gram-Negative Bacterial InfectionsTo evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.