Trial Outcomes & Findings for Post Marketing Surveillance Study on Linezolid (NCT NCT01564758)

NCT ID: NCT01564758

Last Updated: 2012-08-06

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 99 participants
• Primary outcome timeframe: Baseline up to End of Treatment (EOT) (Day 10 up to 28)
• Results posted on: 2012-08-06

Participant Flow

Participant milestones

Measure	Linezolid 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 Study STARTED	99
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Linezolid 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 Study Death	8
Overall Study Adverse Event	3
Overall Study Other	3

Baseline Characteristics

Post Marketing Surveillance Study on Linezolid

Baseline characteristics by cohort

Measure	Linezolid n=99 Participants 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.
Age Continuous	59.7 years STANDARD_DEVIATION 18.2 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to End of Treatment (EOT) (Day 10 up to 28)

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

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

Outcome measures

Measure	Linezolid n=99 Participants 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.
Number of Participants With Adverse Events (AEs)	15 participants

SECONDARY outcome

Timeframe: EOT (Day 10 up to 28)

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

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.

Outcome measures

Measure	Linezolid n=99 Participants 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.
Number of Participants With Clinical Response Cure	57 participants
Number of Participants With Clinical Response Improvement	31 participants
Number of Participants With Clinical Response Failure	11 participants

Adverse Events

Linezolid

Serious events: 10 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Linezolid n=99 participants at risk 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.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/99 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.
Cardiac disorders Cardio-respiratory arrest	1.0% 1/99 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.
Cardiac disorders Cardiopulmonary failure	1.0% 1/99 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.
General disorders Ill-defined disorder	3.0% 3/99 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.
Infections and infestations Septic shock	1.0% 1/99 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.
Metabolism and nutrition disorders Metabolic acidosis	1.0% 1/99 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.
Nervous system disorders Haemorrhage intracranial	1.0% 1/99 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.
Renal and urinary disorders Renal failure acute	1.0% 1/99 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/99 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.

Other adverse events

Measure	Linezolid n=99 participants at risk 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.
Blood and lymphatic system disorders Thrombocytopenia	3.0% 3/99 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.
Gastrointestinal disorders Nausea	1.0% 1/99 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.
Skin and subcutaneous tissue disorders Rash	1.0% 1/99 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER