A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000412-33-LV
• Date of registration: 31/10/2008
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
• Public title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA
• Scientific title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA
• Date of first enrolment: 19/12/2008
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000412-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Estonia, France, Hungary, Latvia

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female subjects =18 years of age known or suspected to have acute HAP.
- Acute HAP is defined as pneumonia with onset of symptoms:
a. = 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit.
b. = 7 days after the subject was discharged from the hospital. The initial hospitalization must have been =3 days duration.
- VAP is defined as: onset of symptoms of pneumonia = 48 hours after endotracheal intubation.
Presence of a new or evolving infiltrate on a chest x-ray film, presence of fever or leukocytosis, respiratory failure requiring mechanical ventilation or presence of 2 of the following clinical signs and symptoms: cough or dyspnea, tachypnea or pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects with other significant underlying conditions that would make it difficult to evaluate the subjects or make it unlikely to complete the therapy or that would increase their risk by participating in the study, infection with organisms known to be resistant, contraindications, or hypersensitivity to any of the test articles, known Legionella infection, known Pseudomonas aeruginosa infection, hemodialysis, hemofiltration, peritoneal dialysis, plasmapheresis, presence of sustained shock, Acute Physiologic and Chronic Health Evaluation Scale (APACHE) II score > 30, significant neutropenia, hepatic and/or renal insufficiency, antibacterial drugs administered for > 24 hours before study entry unless resistance demonstrated or no improvement, known human immunodeficiency virus (HIV) infection, pregnant women or nursing mothers.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)
MedDRA version: 9.1 Level: PT Classification code 10035664 Term: Pneumonia

Intervention(s)

Trade Name: Tygacil 50 mg powder for solution for infusion
Product Name: Tygacil (tigecycline)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TIGECYCLINE
CAS Number: 220620-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Imipenem/Cilastatin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: IMIPENEM
CAS Number: 64221869
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: CILASTATIN
CAS Number: 82009345
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Secondary Objective: Secondary objectives are:
(1) to evaluate tigecycline efficacy in treating the VAP/non-VAP subject subpopulations;
(2) to evaluate the microbiologic efficacy of tigecycline;
(3) to obtain in vitro susceptibility data on tigecycline for a range of bacteria that cause HAP;
(4) to obtain pharmacokinetic (PK)/pharmacodynamic (PD) information for these higher dose regimens of tigecycline in subjects with HAP;
(5) to compare procalcitonin levels between treatment groups and explore the relationship between procalcitonin concentrations and response to treatment in subjects with HAP;
(6) to compare health care resource utilization between treatment groups.

Primary end point(s): The primary efficacy endpoint is the clinical response in the clinically evaluable (CE) population at the Test-of-Cure (TOC) assessment, 10-21 days post therapy (primary time point)

Main Objective: The primary objective of this study is to compare the safety and efficacy of 2 higher tigecycline dose regimens with that of the imipenem/cilastatin regimen in order to determine the dose(s) of tigecycline that will be tolerable and non-inferior to imipenem/cilastatin in treating subjects with HAP.

Secondary ID(s)

2008-000412-33-HU

3074K6-2000-WW