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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)