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Report for D014552: Urinary Tract Infections NIH

(Synonyms: Urinary Trac, Urinary Tract Infecti, Urinary Tract Infections)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug1161 GSK3882347 Wiki 0.71
drug340 BI 1569912 Wiki 0.71
drug2884 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.71
drug2122 Placebo Wiki 0.07

Correlated MeSH Terms (19)


Name (Synonyms) Correlation
D001997 Bronchopulmonary Dysplasia NIH 0.71
D008595 Menorrhagia NIH 0.71
D006929 Hyperaldosteronism NIH 0.71
D054559 Hyperphosphatemia NIH 0.71
D004314 Down Syndrome NIH 0.71
D000309 Adrenal Insufficiency NIH 0.71
D007008 Hypokalemia NIH 0.71
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.50
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.35
D006470 Hemorrhage NIH 0.35
D020141 Hemostatic Disorders NIH 0.19
D001778 Blood Coagulation Disorders NIH 0.19
D006973 Hypertension NIH 0.18
D004194 Disease NIH 0.12
D013577 Syndrome NIH 0.07
D003141 Communicable Diseases NIH 0.06
D007239 Infection NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0002905 Hyperphosphatemia HPO 0.71
HP:0002900 Hypokalemia HPO 0.71
HP:0000846 Adrenal insufficiency HPO 0.71
HP:0000132 Menorrhagia HPO 0.71
HP:0000859 Hyperaldosteronism HPO 0.71
HP:0007018 Attention deficit hyperactivity disorder HPO 0.35
HP:0001928 Abnormality of coagulation HPO 0.19
HP:0000822 Hypertension HPO 0.18

There are 2 clinical trials

Clinical Trials


1 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia In Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Fibrinolysis; Hemorrhage Attention Deficit Hyperactivity Disorder Multisystem Inflammatory Syndrome in Children (MIS-C) Kawasaki Disease Coagulation Disorder Down Syndrome Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

2 A Double-Blind Randomized, Placebo-Controlled, Single and Repeated Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of GSK3882347 in Healthy Participants

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.

NCT04488770 Urinary Tract Infections Drug: GSK3882347 Drug: Placebo
MeSH:Urinary Tract Infections

Primary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Measure: Part 1: Number of participants with Adverse events (AEs)

Time: Up to Week 15

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Measure: Part 2: Number of participants with AEs

Time: Up to Week 4

Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.

Measure: Part 1: Number of participants with treatment related AEs

Time: Up to Week 15

Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.

Measure: Part 2: Number of participants with treatment related AEs

Time: Up to Week 4

Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal findings in hematology parameters

Time: Up to Week 15

Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal findings in hematology parameters

Time: Up to Week 4

Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal findings in clinical chemistry parameters

Time: Up to Week 15

Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal findings in clinical chemistry parameters

Time: Up to Week 4

Description: Number of participants with abnormal urinalysis parameters will be assessed.

Measure: Part 1: Number of participants with abnormal urinalysis results

Time: Up to Week 15

Description: Number of participants with abnormal urinalysis parameters will be assessed.

Measure: Part 2: Number of participants with abnormal urinalysis results

Time: Up to Week 4

Description: Number of participants with clinically significant abnormal vital signs will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal vital signs

Time: Up to Week 15

Description: Number of participants with clinically significant abnormal vital signs will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal vital signs

Time: Up to Week 4

Description: Number of participants with abnormal ECG parameters will be assessed.

Measure: Part 1: Number of participants with clinically significant abnormal Electrocardiogram (ECG) findings

Time: Up to Week 15

Description: Number of participants with abnormal ECG parameters will be assessed.

Measure: Part 2: Number of participants with clinically significant abnormal ECG findings

Time: Up to Week 4

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Area under the concentration-time curve from time zero to 24 hours after dosing (AUC [0-24]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC extrapolated from time zero to infinity (AUC[0-inf]) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Maximum plasma concentration (Cmax) of GSK3882347 single dose (nanograms per milliliter)

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Plasma concentrations at 24 hours after dosing (C24h) of GSK3882347 single dose

Time: Day 1: 24 hour post dose in each treatment period

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Time to Cmax (Tmax) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Lag time for absorption (tlag) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Terminal elimination half-life (T1/2) of GSK3882347 single dose

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: AUC over the dosing interval tau (AUC[0-tau]) of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Cmax of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Tmax of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 repeat dose

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]

Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.

Measure: Part 1: Urine concentration at 22-24 hours collection time point

Time: Day 1 [22-24 hours post dose in each treatment period]

Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.

Measure: Part 2: Urine concentration at 22-24 hours collection time point

Time: Days 1 and 7 [22-24 hours post dose]

Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.

Measure: Part 1: Amount excreted in urine (Ae) of unchanged GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hour post dose in each treatment period]

Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.

Measure: Part 2: Amount excreted in urine (Ae) of unchanged GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hour post dose]

Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.

Measure: Part 1 Fraction of the dose excreted in urine (fe) following single dose GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose in each treatment period]

Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.

Measure: Part 2: Fraction of the dose excreted in urine (fe) following single dose GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose in each of the 4 cohorts]

Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.

Measure: Part 1: Renal clearance (CLr) following single dose GSK3882347

Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose]

Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.

Measure: Part 2: Renal clearance (CLr) following single dose GSK3882347

Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose]

Secondary Outcomes

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: AUC from time zero to 12 hours after dosing (AUC[0-12]) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Plasma concentrations at 12 hours (C12) following single dose of GSK3882347

Time: Day 1 [12 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Apparent oral clearance (CL/F) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Apparent volume of distribution after non-intravenous administration (Vd/F) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 1: Mean residence time (MRT) following single dose of GSK3882347

Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: AUC[0-12] following repeat dose of GSK3882347

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12, hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: C12 following repeat dose of GSK3882347

Time: Days 1 and Day 7 [12 hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.

Measure: Part 2: Observed accumulation ratio (Ro) using AUC(0-tau) following repeat dose of GSK3882347

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347. The time invariance will be estimated by calculating the ratio of AUC(0-tau) on Day 7 to AUC(0-inf) on Day 1.

Measure: Part 2: Time invariance of GSK3882347 using AUC(0-tau) (repeat dose) and AUC(0-inf) (single dose)

Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]

Description: Blood samples will be collected at indicated time points to confirm achievement of steady-state of GSK3882347 after repeated dosings.

Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 after repeat doses

Time: Pre-dose on Days 3 through 7


HPO Nodes