NCT03174795

Brief Summary

This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with meropenem.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1

Geographic Reach
5 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

May 31, 2017

Last Update Submit

May 11, 2018

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (8)

  • Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • Total Clearance (CL) of RO7079901

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • Renal Clearance (CLr) of RO7079901

    Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  • Maximum Observed Plasma Concentration (Cmax) of RO7079901

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901

    Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  • Fraction Excreted into the Urine (Fe) of RO7079901

    Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  • Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • Steady State Volume of Distribution (Vss) of RO7079901

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Secondary Outcomes (8)

  • AUC0-tau of Meropenem

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • CL of Meropenem

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • CLr of Meropenem

    Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  • Cmax of Meropenem

    Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

  • Ae of Meropenem

    Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

  • +3 more secondary outcomes

Study Arms (1)

RO7079901 and Meropenem

EXPERIMENTAL

Participants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.

Drug: RO7079901Drug: Meropenem

Interventions

RO7079901DRUG

Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.

RO7079901 and Meropenem
MeropenemDRUG

Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.

RO7079901 and Meropenem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)
  • Clinical signs and/or symptoms of pyelonephritis or a cUTI
  • Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (\>)1x10\^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism
  • Negative urine pregnancy test result confirmed by a blood test
  • Agreement to remain abstinent or use a contraceptive method

You may not qualify if:

  • Has a concomitant infection requiring antibacterial therapy, in addition to study drug
  • Confirmed fungal urinary tract infection
  • Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant
  • Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy
  • Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period
  • Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry
  • Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)
  • Suspected or confirmed perinephric or intra renal abscess
  • Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion
  • History of epilepsy, brain lesions or other significant neurological disorders
  • Use of probenecid within the 7 days before enrollment
  • Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic
  • Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study
  • Women who are pregnant, planning to become pregnant, or lactating
  • Participation in a clinical study of an investigational drug or device within one month prior to enrollment
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

eStudySite

La Mesa, California, 91942, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32216, United States

Location

Semmelweis University, First Dept of Medicine

Budapest, 1083, Hungary

Location

Szent Imre Egyetemi Oktatokorhaz

Budapest, 1115, Hungary

Location

Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet

Debrecen, 4012, Hungary

Location

Liepaja Regional hospital

Liepāja, 3414, Latvia

Location

P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology

Riga, LV-1002, Latvia

Location

Riga East clinical university hospital

Riga, LV1006, Latvia

Location

Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology

Bydgoszcz, 85-094, Poland

Location

Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek

Lodz, 92-213, Poland

Location

Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii

Warsaw, 02-005, Poland

Location

Clinical Center of Serbia; Clinic of Urology

Belgrade, 11000, Serbia

Location

Clinical Center Zemun

Belgrade, 11080, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Meropenem

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

July 11, 2017

Primary Completion

December 4, 2017

Study Completion

December 16, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

US(2)LA(3)HU(3)SE(3)PL(3)