Trial intelligence / Profile preview

Combination Antibiotic Therapy for XDR-GNB Infections

NCT02134106Phase 3

Key facts

Status: Withdrawn
Start: Jan 2015
Primary completion: Oct 2015
Countries: 1
Sponsor: Tan Tock Seng Hospital
Modality: Small Molecules

Drugs: doripenem
Conditions: Bacteremiaventilator-associated pneumonia (VAP)Healthcare-associated pneumonia (HCAP)

Overview

Phase 3, randomised, open-label trial of doripenem in Bacteremia, ventilator-associated pneumonia (VAP) and Healthcare-associated pneumonia (HCAP) (2 arms), sponsored by Tan Tock Seng Hospital. Primary endpoint: All-cause mortality at 30 days post-randomization. Planned start Jan 2015; status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Polymyxin B
IV Polymyxin B (25,000 U/kg/day) + Nebulized Colistin (if VAP)
Polymyxin B + Doripenem
IV Polymyxin B (25,000 U/kg/day) + IV Doripenem (500mg q8h) + Nebulized Colistin (if VAP)

Who it enrols

Patients with monomicrobial XDR-GNB bacteremia, ventilator-associated pneumonia, or healthcare-associated pneumonia. Excludes patients with severe renal impairment (CrCl < 30 mL/min), pregnancy, co-infection with other aerobic Gram-negative bacteria, or life expectancy < 24 hours.

Endpoints

Primary

All-cause mortality at 30 days post-randomization30 days

Secondary

Microbiological clearance7 days
Time to defervescence30 days
Duration of stay in ICU30 days
Clinical improvement3 days
Clinical progression30 days

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