Post-Authorization Study Evaluating Safety Of Tigecycline - Study Results

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Intra-Abdominal Infections Skin Disease, Infectious Soft Tissues Infections
Intervention:	Drug: Tigecycline

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.

Participant Flow: Overall Study

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections
STARTED	19	96
COMPLETED	15	85
NOT COMPLETED	4	11
Exitus	1	8
Unspecified	1	3
Pathogen not susceptible	1	0
Lack of effectiveness	1	0

Baseline Characteristics

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Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Total	Total of all reporting groups

Baseline Measures

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections	Total
Number of Participants [units: participants]	19	96	115
Age [units: years] Mean ± Standard Deviation	61.53 ± 11.01	59.27 ± 16.47	59.64 ± 15.68
Gender [units: participants]
Female	5	47	52
Male	14	49	63

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 12 ]

Measure Type	Primary
Measure Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measure Description	Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Up to Week 12
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.

Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.

Measured Values

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections
Number of Participants Analyzed [units: participants]	19	96
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [units: participants]
AEs	11	45
SAEs	4	28

No statistical analysis provided for Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

2. Secondary:

Percentage of Participants With Clinical Response of Cure [ Time Frame: Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Clinical Response of Cure
Measure Description	Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician.
Time Frame	Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-To-Treat (ITT) population included all evaluable participants who had at least one dose of study medication and one evaluation visit. 'n' signifies those participants who were evaluated for this measure at specified time points for each group respectively.

Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.

Measured Values

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections
Number of Participants Analyzed [units: participants]	19	96
Percentage of Participants With Clinical Response of Cure [units: percentage of participants]
On Days 2 to 5 (n= 19, 94)	10.5	18.1
On Days 7 to 14 (n= 13, 70)	46.2	42.9
On Days 21 to 28 (n= 6, 32)	66.7	68.8
On Days 1 to 3 after end of treatment (n= 19, 96)	68.4	76.0

No statistical analysis provided for Percentage of Participants With Clinical Response of Cure

3. Secondary:

Number of Participants With Susceptible Microbiological Pathogens [ Time Frame: Baseline and Week 12 ]

Measure Type	Secondary
Measure Title	Number of Participants With Susceptible Microbiological Pathogens
Measure Description	Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb.
Time Frame	Baseline and Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.

Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.

Measured Values

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections
Number of Participants Analyzed [units: participants]	0	0
Number of Participants With Susceptible Microbiological Pathogens [units: participants]

No statistical analysis provided for Number of Participants With Susceptible Microbiological Pathogens

4. Secondary:

Number of Participants With Eradication of Microbiological Pathogens [ Time Frame: Week 12 ]

Measure Type	Secondary
Measure Title	Number of Participants With Eradication of Microbiological Pathogens
Measure Description	Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb.
Time Frame	Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data was not analyzed since the number of samples obtained for culture was very low.

Reporting Groups

	Description
Complicated Skin and Soft-tissue Infections	Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
Complicated Intra-Abdominal Infections	Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.

Measured Values

	Complicated Skin and Soft-tissue Infections	Complicated Intra-Abdominal Infections
Number of Participants Analyzed [units: participants]	0	0
Number of Participants With Eradication of Microbiological Pathogens [units: participants]

No statistical analysis provided for Number of Participants With Eradication of Microbiological Pathogens

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827541 History of Changes
Other Study ID Numbers:	B1811048, 3074A1-4401
Study First Received:	January 20, 2009
Results First Received:	December 23, 2011
Last Updated:	December 23, 2011
Health Authority:	Spain: Ministry of Health

Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)