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Study for the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis

2014-08-27 03:14:51 | BioPortfolio

Summary

Multi-center, multi-national, double-blind, randomized, comparator-controlled study of ACHN-490 Injection administered IV, given at two different durations compared to patients receiving a standard approved IV therapy for complicated urinary tract infection/acute pyelonephritis (cUTI/AP). Patients with a clinical diagnosis of cUTI/AP sufficient to start empiric IV antibiotics will be randomly assigned to one of three treatment regimens.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Complicated Urinary Tract Infection

Intervention

Levofloxacin, ACHN-490 Injection, ACHN-490 Injection

Location

Pan American Hospital
Miami
Florida
United States
33126

Status

Recruiting

Source

Achaogen, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:51-0400

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Medical and Biotech [MESH] Definitions

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

Total or subtotal destruction of the pituitary gland by chemical injection. It is usually achieved by injection of ethyl alcohol via trans-sphenoidal cannulation under stereotaxic control. It is usually performed for the treatment of intractable pain.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

Hemorrhagic necrosis that was first demonstrated in rabbits with a two-step reaction, an initial local (intradermal) or general (intravenous) injection of a priming endotoxin (ENDOTOXINS) followed by a second intravenous endotoxin injection (provoking agent) 24 h later. The acute inflammation damages the small blood vessels. The following intravascular coagulation leads to capillary and venous THROMBOSIS and NECROSIS. Shwartzman phenomenon can also occur in other species with a single injection of a provoking agent, and during infections or pregnancy. Its susceptibility depends on the status of IMMUNE SYSTEM, coagulation, FIBRINOLYSIS, and blood flow.

The analysis of a chemical substance by inserting a sample into a carrier stream of reagent using a sample injection valve that propels the sample downstream where mixing occurs in a coiled tube, then passes into a flow-through detector and a recorder or other data handling device.

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