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Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00827541
First received: January 20, 2009
Last updated: December 23, 2011
Last verified: December 2011
History of Changes
Results First Received: December 23, 2011  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Susceptible Microbiological Pathogens   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Eradication of Microbiological Pathogens   [ Time Frame: Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional 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.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

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.

Other Adverse Events
    Complicated Skin and Soft-tissue Infections     Complicated Intra-Abdominal Infections  
Total, other (not including serious) adverse events      
# participants affected / at risk     7/19     23/96  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Gastrointestinal disorders      
Abdominal pain * 1    
# participants affected / at risk     0/19 (0.00%)     10/96 (10.42%)  
Intestinal fistula * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Vomiting * 1    
# participants affected / at risk     1/19 (5.26%)     1/96 (1.04%)  
Retching * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Haematemesis * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Gastric haemorrhage * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
General disorders      
Pyrexia * 1    
# participants affected / at risk     0/19 (0.00%)     5/96 (5.21%)  
Ill-defined disorder * 1    
# participants affected / at risk     1/19 (5.26%)     1/96 (1.04%)  
Device related infection * 1    
# participants affected / at risk     0/19 (0.00%)     2/96 (2.08%)  
Pain * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Hepatobiliary disorders      
Cholelithiasis * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Biliary fistula * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Infections and infestations      
Soft tissue infection * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Escherichia infection * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Cytomegalovirus infection * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Bacterial infection * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Injury, poisoning and procedural complications      
Wound infection * 1    
# participants affected / at risk     0/19 (0.00%)     5/96 (5.21%)  
Postoperative wound infection * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Investigations      
White blood cell count * 1    
# participants affected / at risk     0/19 (0.00%)     5/96 (5.21%)  
C-reactive protein * 1    
# participants affected / at risk     1/19 (5.26%)     2/96 (2.08%)  
Body temperature increased * 1    
# participants affected / at risk     0/19 (0.00%)     4/96 (4.17%)  
White blood cell count increased * 1    
# participants affected / at risk     0/19 (0.00%)     3/96 (3.13%)  
C-reactive protein increased * 1    
# participants affected / at risk     0/19 (0.00%)     3/96 (3.13%)  
Platelet count increased * 1    
# participants affected / at risk     0/19 (0.00%)     2/96 (2.08%)  
White blood cell analysis increased * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Transaminases abnormal * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Neutrophil count increased * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Haemoglobin decreased * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Blood bilirubin increased * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Blood amylase increased * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Alanine aminotransferase increased * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Metabolism and nutrition disorders      
Hyponatraemia * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Nervous system disorders      
Grand mal convulsion * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Renal and urinary disorders      
Renal failure * 1    
# participants affected / at risk     1/19 (5.26%)     4/96 (4.17%)  
Respiratory, thoracic and mediastinal disorders      
Pleural effusion * 1    
# participants affected / at risk     1/19 (5.26%)     0/96 (0.00%)  
Pneumonia * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Pneumothorax * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Skin and subcutaneous tissue disorders      
Paronychia * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
Vascular disorders      
Phlebitis * 1    
# participants affected / at risk     0/19 (0.00%)     1/96 (1.04%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA



  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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