GSK2251052 in Complicated Urinary Tract Infection

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Infections, Urinary Tract

In brief

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.

Key facts

Study ID

NCT01381549

Run by

GlaxoSmithKline

People needed

20

Starts

2011-06-28

Expected to finish

2012-03-06

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects least 18 years of age.
• N.B. Females of non-childbearing or childbearing potential may be enrolled. Females of childbearing potential must have a negative pregnancy test at study entry and must have practiced adequate contraception for at least 30 days prior to study entry. Additionally, the subject agrees to one of the following methods for avoidance of pregnancy during the entire study treatment period:
• Abstinence; or,
• Oral Contraceptive, either combined estrogen/progesterone or progesterone alone, PLUS an additional barrier method [ie, condom, occlusive cap (diaphragm or cervical/vault caps) or vaginal spermicidal agent (foam/gel/film/cream/suppository)]; or,
• Injectable progesterone; or
• Implants of levonorgestrel; or,
• Estrogenic vaginal ring; or,
• Percutaneous contraceptive patches; or
• Intrauterine device (IUD) or intrauterine system (IUS) showing that failure rate is less than 1% in the IUD or IUS product label; or,
• Has a male partner who is sterilized (vasectomy with documentation of azoospermia).
• Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
• Females are considered to be of non-childbearing potential if they have documented tubal ligation or hysterectomy; or are postmenopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]
• Subject requires hospitalisation and has clinical signs and symptoms of lower cUTI or pyelonephritis (complicated or uncomplicated) as defined below, that requires parenteral treatment only with a treatment course of a minimum of 5 days and a maximum of 14 days:
• Lower cUTI - subjects must have documented fever defined as >38°C oral, >38.5°C tympanic or >39°C rectal, within the last 24 hours exceptions would be:
• Afebrile subjects with lower cUTI who have a white blood cell count (WBC) ≥15,000 cells/mm3
• Afebrile subjects with a lower cUTI following requiring parenteral therapy due to a specific indication e.g. before and during an operative procedure, when oral antibiotics are not indicated or in cases where the cUTI is suspected to be due to a pathogen resistant to current oral antibiotics
• and at least two of the following UTI symptoms including dysuria, frequency, urgency or suprapubic pain, with the presence of a complicating factor:
• Male gender;
• Current bladder instrumentation or indwelling urinary catheter that has to be removed two days before the end of IV study drug administration;
• Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
• Urogenital surgery within 7 days preceding administration of the first dose of study drug;
• Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.
• Acute pyelonephritis (complicated or uncomplicated): subjects must have documented fever defined as >38°C oral, >38.5°C tympanic or >39°C rectal, within the last 24 hours and flank pain or costovertebral angle tenderness (CVA). Complicating factors for pyelonephritis are the same as for complicated UTI.
• Subject has pyuria (white blood cell [WBC] count > 10/µL (or >5/high-power field [HPF] in a conventional urinalysis) in unspun clean-catch midstream urine (MSU) or catheter urine sample or >= 10 WBC/HPF in spun MSU or catheter urine).
• Subject has Gram-negative organism(s) on direct examination of a Gram-stained specimen from unspun or spun MSU or catheter urine sample.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Council Bluffs, Iowa, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Corsicana, Texas, United States
• GSK Investigational Site — Chicoutimi, Quebec, Canada
• GSK Investigational Site — Sherbrooke, Quebec, Canada
• GSK Investigational Site — Suresnes, France
• GSK Investigational Site — Toulouse, France
• GSK Investigational Site — Athens, Greece
• GSK Investigational Site — Chaïdári, Greece
• GSK Investigational Site — Goudi, Athens, Greece
• GSK Investigational Site — Thessaloniki, Greece
• GSK Investigational Site — Irkutsk, Russia
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Rostov-on-Don, Russia
• GSK Investigational Site — Smolensk, Russia
• GSK Investigational Site — St'Petersburg, Russia
• GSK Investigational Site — Alicante, Spain
• GSK Investigational Site — Elche (Alicante), Spain
• GSK Investigational Site — Getafe/Madrid, Spain
• GSK Investigational Site — Granada, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Murcia, Spain
• GSK Investigational Site — Pama de Mallorca, Spain

Full record on ClinicalTrials.gov

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