A5951090: Post Marketing Surveillance Study on Linezolid

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01564758
• Collaborator: (none)
• Enrollment: 99
• Duration (Months): 12.9

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections	Drug: Linezolid

Detailed Description

The subjects were identified after the physician decided to prescribed the drug to the subject.

Study Design

• Study Type: Observational
• Actual Enrollment: 99 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Mar 1, 2005
• Actual Study Completion Date: Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Subjects that are diagnosed with gram positive infection	Drug: Linezolid; Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [Baseline up to End of Treatment (EOT) (Day 10 up to 28)]

   Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

Secondary Outcome Measures

1. Number of Participants With Clinical Response [EOT (Day 10 up to 28)]

   Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium

• Male or female, 18 years old and above

Exclusion Criteria:

• Known hypersensitivity

• Subjects diagnosed with pure gram-negative infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01564758
• Other Study ID Numbers: A5951090; GRAM POSITIVE INFECTIONS
• First Posted: Mar 28, 2012
• Last Update Posted: Aug 6, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Pfizer: non-interventional; non-comparative; open-label study; safety; Linezolid; gram positive infections; Filipino
• Additional relevant MeSH terms: Infections; Bacterial Infections; Gram-Positive Bacterial Infections; Linezolid

Study Results

Participant Flow

Arm/Group Title	Linezolid
Arm/Group Description	Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
Period Title: Overall Study
STARTED	99
COMPLETED	85
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Linezolid
Arm/Group Description	Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
Overall Participants	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.7 (18.2)
Sex: Female, Male (Count of Participants)
Female	35 35.4%
Male	64 64.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.
Time Frame	Baseline up to End of Treatment (EOT) (Day 10 up to 28)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all the participants who received at least 1 dose of study medication.

Arm/Group Title	Linezolid
Arm/Group Description	Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
Measure Participants	99
Number [participants]	15 15.2%

2. Secondary Outcome

Title	Number of Participants With Clinical Response
Description	Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.
Time Frame	EOT (Day 10 up to 28)

Outcome Measure Data

Analysis Population Description

Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication

Arm/Group Title	Linezolid
Arm/Group Description	Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
Measure Participants	99
Cure	57 57.6%
Improvement	31 31.3%
Failure	11 11.1%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Linezolid
Arm/Group Description	Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.
All Cause Mortality
	Linezolid
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Linezolid
	Affected / at Risk (%)	# Events
Total	10/99 (10.1%)
Blood and lymphatic system disorders
Thrombocytopenia	1/99 (1%)
Cardiac disorders
Cardio-respiratory arrest	1/99 (1%)
Cardiopulmonary failure	1/99 (1%)
General disorders
Ill-defined disorder	3/99 (3%)
Infections and infestations
Septic shock	1/99 (1%)
Metabolism and nutrition disorders
Metabolic acidosis	1/99 (1%)
Nervous system disorders
Haemorrhage intracranial	1/99 (1%)
Renal and urinary disorders
Renal failure acute	1/99 (1%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/99 (1%)
Other (Not Including Serious) Adverse Events
	Linezolid
	Affected / at Risk (%)	# Events
Total	5/99 (5.1%)
Blood and lymphatic system disorders
Thrombocytopenia	3/99 (3%)
Gastrointestinal disorders
Nausea	1/99 (1%)
Skin and subcutaneous tissue disorders
Rash	1/99 (1%)

Limitations/Caveats

Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.