Trial · NCT01381549
GSK2251052 in Complicated Urinary Tract Infection
NCT01381549, Phase 2, Terminated, GlaxoSmithKline; results first posted 2017-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GSK2251052 in Complicated Urinary Tract Infection. Trials, record NCT01381549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01381549
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GSK2251052 in Complicated Urinary Tract Infection
- NCT number
- NCT01381549
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Urinary Tract
- Interventions
- GSK2251052, imipenem-cilastatin, Placebo
- First posted
- 2011-06-27
- Last updated
- 2017-09-08
- Results first posted
- 2017-09-08
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented. |
| Primary | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented. |
| Primary | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented. |
| Primary | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented. |
| Primary | 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) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented. |
| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 28 days post-therapy | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit. |
| Primary | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to Late Follow up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented. |
| Primary | Summary of Vital Signs- Mean Heart Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented. |
| Primary | Summary of Vital Signs- Mean Respiration Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population which comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. | Gram per Liter | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Milliliter per minute | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Micromole per liter | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Millimole per Liter | MEAN |
| PRIMARY | 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) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | International units per Liter | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 28 days post-therapy | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to Late Follow up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Summary of Vital Signs- Mean Heart Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Beats per minute | MEAN |
| PRIMARY | Summary of Vital Signs- Mean Respiration Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Safety Population. Only those participants available at the specified time points were analyzed. | Breaths/minute | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group682
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 750 mg | Albumin: On IV therapy (Day 5) | -0.5 | Standard Deviation 4.85 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 1500 mg | Albumin: On IV therapy (Day 5) | -3.8 | Standard Deviation 7.09 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Imipenem-Cilastatin | Albumin: On IV therapy (Day 5) | -0.3 | Standard Deviation 3.06 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 750 mg | Albumin: On IV therapy (Day 11) | 2.0 | Standard Deviation NA | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 750 mg | Albumin: End of IV therapy | 1.0 | Standard Deviation 4.69 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 1500 mg | Albumin: End of IV therapy | -2.1 | Standard Deviation 7.38 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Imipenem-Cilastatin | Albumin: End of IV therapy | 0.8 | Standard Deviation 3.31 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 750 mg | Albumin: Test of Cure | 5.7 | Standard Deviation 3.67 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | GSK2251052 1500 mg | Albumin: Test of Cure | 1.7 | Standard Deviation 5.79 | Gram per Liter |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Imipenem-Cilastatin | Albumin: Test of Cure | 2.6 | Standard Deviation 2.61 | Gram per Liter |
1 to 10 of 682Source ClinicalTrials.gov
See all 682 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK2251052 750 mg | 6 | |
| Overall Study | STARTED | GSK2251052 1500 mg | 8 | |
| Overall Study | STARTED | Imipenem-Cilastatin | 6 | |
| Overall Study | COMPLETED | GSK2251052 750 mg | 6 | |
| Overall Study | COMPLETED | GSK2251052 1500 mg | 8 | |
| Overall Study | COMPLETED | Imipenem-Cilastatin | 5 | |
| Overall Study | NOT COMPLETED | GSK2251052 750 mg | 0 | |
| Overall Study | NOT COMPLETED | GSK2251052 1500 mg | 0 | |
| Overall Study | NOT COMPLETED | Imipenem-Cilastatin | 1 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | GSK2251052 750 mg | 0 | 6 | |
| other | Nausea | Gastrointestinal disorders | GSK2251052 1500 mg | 2 | 8 | |
| other | Nausea | Gastrointestinal disorders | Imipenem-Cilastatin | 1 | 6 | |
| other | Abdominal pain upper | Gastrointestinal disorders | GSK2251052 750 mg | 0 | 6 | |
| other | Abdominal pain upper | Gastrointestinal disorders | GSK2251052 1500 mg | 0 | 8 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Imipenem-Cilastatin | 1 | 6 | |
| other | Dyspepsia | Gastrointestinal disorders | GSK2251052 750 mg | 0 | 6 | |
| other | Dyspepsia | Gastrointestinal disorders | GSK2251052 1500 mg | 0 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Imipenem-Cilastatin | 1 | 6 | |
| other | Rectal haemorrhage | Gastrointestinal disorders | GSK2251052 750 mg | 0 | 6 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK2251052 750 mg | 0 | 6 |
| Total, all-cause mortality | GSK2251052 1500 mg | 0 | 8 |
| Total, all-cause mortality | Imipenem-Cilastatin | 0 | 6 |
| Total, other adverse events | GSK2251052 750 mg | 5 | 6 |
| Total, other adverse events | GSK2251052 1500 mg | 5 | 8 |
| Total, other adverse events | Imipenem-Cilastatin | 5 | 6 |
| Total, serious adverse events | GSK2251052 750 mg | 1 | 6 |
| Total, serious adverse events | GSK2251052 1500 mg | 2 | 8 |
| Total, serious adverse events | Imipenem-Cilastatin | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25348524 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01381549
GET https://conductscience.org/api/trials/v1/NCT01381549/registered?page=2