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Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

NCT ID: NCT00707239

Last Updated: 2012-07-10

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 \& up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs.

Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, \& a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

Detailed Description

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The sponsor internal decision has been taken to close the study on 15 of July 2011, due to difficulties in enrollment. This decision was not based on any safety issues.

Conditions

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Pneumonia, Bacterial

Keywords

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Hospital-acquired pneumonia Ventilator-associated pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

tigecycline

Intervention Type DRUG

An initial intravenous (IV) loading dose of 150 mg of tigecycline, followed by 75 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

B

Group Type EXPERIMENTAL

tigecycline

Intervention Type DRUG

An initial intravenous (IV) loading dose of 200 mg of tigecycline, followed by 100 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

C

Group Type ACTIVE_COMPARATOR

imipenem/cilastatin

Intervention Type DRUG

Imipenem/cilastatin 1g intravenous (IV) will be administered approximately every 8 hours, for up to 14 consecutive days. In addition vancomycin 15 mg/kg IV approximately every 12 hours (q12h), an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and ceftazidime placebo will be given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

Interventions

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tigecycline

An initial intravenous (IV) loading dose of 150 mg of tigecycline, followed by 75 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

Intervention Type DRUG

tigecycline

An initial intravenous (IV) loading dose of 200 mg of tigecycline, followed by 100 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

Intervention Type DRUG

imipenem/cilastatin

Imipenem/cilastatin 1g intravenous (IV) will be administered approximately every 8 hours, for up to 14 consecutive days. In addition vancomycin 15 mg/kg IV approximately every 12 hours (q12h), an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and ceftazidime placebo will be given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, greater than or equal to 18 years of age, known or suspected to have acute hospital-acquired pneumonia (HAP).
* Acute HAP is defined as pneumonia with onset of symptoms:

1. Greater than or equal to 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit. Or
2. Less than or equal to 7 days after the subject was discharged from the hospital. The initial hospitalization must have been greater than or equal to 3 days duration.
* VAP is defined as: onset of symptoms of pneumonia greater than or equal to 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, dyspnea or tachypnea, pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.

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, contraindication, or hypersensitivity to any of the test articles.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Pfizer Investigational Site

Morgantown, West Virginia, United States

Site Status

Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Godoy Cruz, Mendoza Province, Argentina

Site Status

Pfizer Investigational Site

Provincia de Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Nambour, Queensland, Australia

Site Status

Pfizer Investigational Site

Victoria, Victoria, Australia

Site Status

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

São José do Rio Preto, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Chicoutimi, Quebec, Canada

Site Status

Pfizer Investigational Site

Trois-Rivières, Quebec, Canada

Site Status

Pfizer Investigational Site

Santiago, Santiago Metropolitan, Chile

Site Status

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Site Status

Pfizer Investigational Site

Bogotá, , Colombia

Site Status

Pfizer Investigational Site

Zagreb, , Croatia

Site Status

Pfizer Investigational Site

Argenteuil, , France

Site Status

Pfizer Investigational Site

Debrecen, , Hungary

Site Status

Pfizer Investigational Site

Nyíregyháza, , Hungary

Site Status

Pfizer Investigational Site

Székesfehérvár, , Hungary

Site Status

Pfizer Investigational Site

Vác, , Hungary

Site Status

Pfizer Investigational Site

Daugavpils, , Latvia

Site Status

Pfizer Investigational Site

Riga, , Latvia

Site Status

Pfizer Investigational Site

Riga, , Latvia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Novosibirsk, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Vsevolozhsk, , Russia

Site Status

Pfizer Investigational Site

Seoul, Korea, South Korea

Site Status

Pfizer Investigational Site

Seoul, Korea, South Korea

Site Status

Pfizer Investigational Site

Seoul, Korea, South Korea

Site Status

Pfizer Investigational Site

Seoul, Korea, South Korea

Site Status

Pfizer Investigational Site

Tainan City, Taiwan, Taiwan

Site Status

Pfizer Investigational Site

Taipei, Taiwan, Taiwan

Site Status

Pfizer Investigational Site

Tainan City, , Taiwan

Site Status

Pfizer Investigational Site

Taipei TOC, , Taiwan

Site Status

Countries

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Belarus Estonia Israel Mexico United States Argentina Australia Brazil Canada Chile Colombia Croatia France Hungary Latvia Russia South Korea Taiwan

References

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Ramirez J, Dartois N, Gandjini H, Yan JL, Korth-Bradley J, McGovern PC. Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia. Antimicrob Agents Chemother. 2013 Apr;57(4):1756-62. doi: 10.1128/AAC.01232-12. Epub 2013 Jan 28.

Reference Type DERIVED
PMID: 23357775 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3074K6-2000&StudyName=Study%20Evaluating%20Safety%20and%20Efficacy%20of%20Tigecycline%20Versus%20Imipenem/Cilastatin%20Subjects%20With%20Hospital-Acquired%20Pneumonia

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1811004

Identifier Type: -

Identifier Source: secondary_id

3074K6-2000

Identifier Type: -

Identifier Source: org_study_id