Stopped: Microbiological findings of resistance on therapy in patients with complicated urinary tract infection
This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.
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Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Timeframe: Up to 28 days post-therapy
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)
Summary of Vital Signs- Mean Heart Rate
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Summary of Vital Signs- Mean Respiration Rate
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Summary of Vital Signs- Mean Temperature
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)
Therapeutic Response at the Test of Cure Visit
Timeframe: Test of Cure Visit (5 to 9 days post-IV therapy)
Change From Baseline in Hematology Parameters- Hematocrit
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)