CTRI/2014/05/004622
Active, not recruiting
Phase 3
Phase III, Randomized, Multicentre, Double-blind, Double-dummy,Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Versus Meropenem in the Treatment of Nosocomial Pneumonia (NP) Including Ventilator-Associated Pneumonia (VAP) in Hospitalised Adults - REPROVE
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AstraZeneca AB
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 90 years of age inclusive.
- •Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after last dose of IV study therapy.
- •Onset of symptoms more than or equal to 48 hours after admission or less than 7 days after discharge from an inpatient acute or chronic care facility.
- •New or worsening infiltrate on chest X\-ray obtained within 48 hours prior to randomization.
- •At least 1 of the following systemic signs: Fever (temperature more than 38 degree C) or hypothermia (rectal/core temperature less than 35 degree C); White blood cell count more than10,000 cells/mm3, or White blood cell count less than 4500 cells/mm3, or more than15% band forms.
Exclusion Criteria
- •Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
- •Patients with lung abscess, pleural empyema or post obstructive pneumonia.
- •Patients with an estimated creatinine clearance 16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
- •Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
- •Patients receiving hemodialysis or peritoneal dialysis.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast.breastcancermammacarcinoma10006291NL-OMON30924Bracco-Byk40
Active, not recruiting
Not Applicable
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance® with Magnevist® in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast (DETECT) - DETECTSuspected or known breast cancer in femalesMedDRA version: 9.1Level: LLTClassification code 10006188Term: Breast cancer female NOSEUCTR2006-004613-18-NLBracco Imaging S.p.A.130
Active, not recruiting
Phase 1
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance® with Magnevist® in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast (DETECT) - DETECTEUCTR2006-004613-18-GBBracco Imaging S.p.A.130
Active, not recruiting
Not Applicable
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHancE with MagnevisT in Contrast-Enhanced MagnetiC Resonance Imaging MRI of the BreasT. - DETECT - - DETECT - MultiHance vs. Magnevist in Breast MRIpatiens with breast lesions which are highly suspicious or already known for malignancy which are requested for MRIMedDRA version: 6.1Level: PTClassification code 10006279EUCTR2006-004613-18-ITBRACCO IMAGING130
Active, not recruiting
Not Applicable
Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance® with Magnevist® in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast (DETECT) - DETECTEUCTR2006-004613-18-DEBracco Imaging S.p.A.130