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Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)

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ClinicalTrials.gov Identifier: NCT00827541
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : February 1, 2012
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Intra-Abdominal Infections
Skin Disease, Infectious
Soft Tissues Infections
Intervention Drug: Tigecycline
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 19 96
Completed 15 85
Not Completed 4 11
Reason Not Completed
Exitus             1             8
Other             1             3
Pathogen not susceptible             1             0
Lack of effectiveness             1             0
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 19 96 115
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 96 participants 115 participants
61.53  (11.01) 59.27  (16.47) 59.64  (15.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 96 participants 115 participants
Female
5
  26.3%
47
  49.0%
52
  45.2%
Male
14
  73.7%
49
  51.0%
63
  54.8%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 96
Measure Type: Number
Unit of Measure: participants
AEs 11 45
SAEs 4 28
2.Secondary Outcome
Title Percentage of Participants With Clinical Response of Cure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 96
Measure Type: Number
Unit of Measure: 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
3.Secondary Outcome
Title Number of Participants With Susceptible Microbiological Pathogens
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Eradication of Microbiological Pathogens
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed since the number of samples obtained for culture was very low.
Arm/Group Title Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
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 Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Affected / at Risk (%) Affected / at Risk (%)
Total   4/19 (21.05%)   28/96 (29.17%) 
Blood and lymphatic system disorders     
Pancytopenia * 1  0/19 (0.00%)  1/96 (1.04%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/19 (0.00%)  1/96 (1.04%) 
Gastrointestinal disorders     
Intestinal fistula * 1  0/19 (0.00%)  3/96 (3.13%) 
Wound evisceration * 1  0/19 (0.00%)  1/96 (1.04%) 
Peritonitis * 1  0/19 (0.00%)  1/96 (1.04%) 
Pancreatitis * 1  0/19 (0.00%)  1/96 (1.04%) 
Intra-abdominal haemorrhage * 1  0/19 (0.00%)  1/96 (1.04%) 
Intestinal ischaemia * 1  0/19 (0.00%)  1/96 (1.04%) 
Gastrointestinal haemorrhage * 1  0/19 (0.00%)  1/96 (1.04%) 
Gastrointestinal disorder * 1  0/19 (0.00%)  1/96 (1.04%) 
Duodenal ulcer * 1  0/19 (0.00%)  1/96 (1.04%) 
Ascites * 1  0/19 (0.00%)  1/96 (1.04%) 
Abdominal sepsis * 1  0/19 (0.00%)  1/96 (1.04%) 
Abdominal pain * 1  0/19 (0.00%)  1/96 (1.04%) 
General disorders     
Multi-organ failure * 1  0/19 (0.00%)  3/96 (3.13%) 
Pyrexia * 1  0/19 (0.00%)  3/96 (3.13%) 
Treatment failure * 1  1/19 (5.26%)  0/96 (0.00%) 
Malaise * 1  0/19 (0.00%)  1/96 (1.04%) 
Ill-defined disorder * 1  0/19 (0.00%)  1/96 (1.04%) 
Aplasia * 1  0/19 (0.00%)  1/96 (1.04%) 
Non specified * 1  1/19 (5.26%)  2/96 (2.08%) 
Hepatobiliary disorders     
Biliary tract disorder * 1  0/19 (0.00%)  1/96 (1.04%) 
Infections and infestations     
Sepsis * 1  1/19 (5.26%)  1/96 (1.04%) 
Perianal abscess * 1  2/19 (10.53%)  0/96 (0.00%) 
Abscess * 1  0/19 (0.00%)  2/96 (2.08%) 
Pneumonia * 1  0/19 (0.00%)  1/96 (1.04%) 
Abdominal abscess * 1  0/19 (0.00%)  1/96 (1.04%) 
Injury, poisoning and procedural complications     
Failure to anastomose * 1  0/19 (0.00%)  2/96 (2.08%) 
Investigations     
Platelet count decreased * 1  0/19 (0.00%)  2/96 (2.08%) 
C-reactive protein * 1  0/19 (0.00%)  1/96 (1.04%) 
Blood creatinine abnormal * 1  0/19 (0.00%)  1/96 (1.04%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  0/19 (0.00%)  1/96 (1.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm * 1  1/19 (5.26%)  1/96 (1.04%) 
Nervous system disorders     
Stupor * 1  0/19 (0.00%)  1/96 (1.04%) 
Loss of consciousness * 1  0/19 (0.00%)  1/96 (1.04%) 
Renal and urinary disorders     
Renal failure * 1  0/19 (0.00%)  1/96 (1.04%) 
Azotaemia * 1  0/19 (0.00%)  1/96 (1.04%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  0/19 (0.00%)  2/96 (2.08%) 
Pleural effusion * 1  0/19 (0.00%)  1/96 (1.04%) 
Acute pulmonary oedema * 1  0/19 (0.00%)  1/96 (1.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Complicated Skin and Soft-tissue Infections Complicated Intra-Abdominal Infections
Affected / at Risk (%) Affected / at Risk (%)
Total   7/19 (36.84%)   23/96 (23.96%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/19 (5.26%)  0/96 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/19 (0.00%)  10/96 (10.42%) 
Intestinal fistula * 1  0/19 (0.00%)  1/96 (1.04%) 
Vomiting * 1  1/19 (5.26%)  1/96 (1.04%) 
Retching * 1  0/19 (0.00%)  1/96 (1.04%) 
Haematemesis * 1  0/19 (0.00%)  1/96 (1.04%) 
Gastric haemorrhage * 1  0/19 (0.00%)  1/96 (1.04%) 
General disorders     
Pyrexia * 1  0/19 (0.00%)  5/96 (5.21%) 
Ill-defined disorder * 1  1/19 (5.26%)  1/96 (1.04%) 
Device related infection * 1  0/19 (0.00%)  2/96 (2.08%) 
Pain * 1  0/19 (0.00%)  1/96 (1.04%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/19 (5.26%)  0/96 (0.00%) 
Biliary fistula * 1  0/19 (0.00%)  1/96 (1.04%) 
Infections and infestations     
Soft tissue infection * 1  1/19 (5.26%)  0/96 (0.00%) 
Escherichia infection * 1  0/19 (0.00%)  1/96 (1.04%) 
Cytomegalovirus infection * 1  1/19 (5.26%)  0/96 (0.00%) 
Bacterial infection * 1  1/19 (5.26%)  0/96 (0.00%) 
Injury, poisoning and procedural complications     
Wound infection * 1  0/19 (0.00%)  5/96 (5.21%) 
Postoperative wound infection * 1  1/19 (5.26%)  0/96 (0.00%) 
Investigations     
White blood cell count * 1  0/19 (0.00%)  5/96 (5.21%) 
C-reactive protein * 1  1/19 (5.26%)  2/96 (2.08%) 
Body temperature increased * 1  0/19 (0.00%)  4/96 (4.17%) 
White blood cell count increased * 1  0/19 (0.00%)  3/96 (3.13%) 
C-reactive protein increased * 1  0/19 (0.00%)  3/96 (3.13%) 
Platelet count increased * 1  0/19 (0.00%)  2/96 (2.08%) 
White blood cell analysis increased * 1  1/19 (5.26%)  0/96 (0.00%) 
Transaminases abnormal * 1  1/19 (5.26%)  0/96 (0.00%) 
Neutrophil count increased * 1  0/19 (0.00%)  1/96 (1.04%) 
Haemoglobin decreased * 1  0/19 (0.00%)  1/96 (1.04%) 
Blood bilirubin increased * 1  0/19 (0.00%)  1/96 (1.04%) 
Blood amylase increased * 1  0/19 (0.00%)  1/96 (1.04%) 
Alanine aminotransferase increased * 1  0/19 (0.00%)  1/96 (1.04%) 
Metabolism and nutrition disorders     
Hyponatraemia * 1  0/19 (0.00%)  1/96 (1.04%) 
Nervous system disorders     
Grand mal convulsion * 1  0/19 (0.00%)  1/96 (1.04%) 
Renal and urinary disorders     
Renal failure * 1  1/19 (5.26%)  4/96 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/19 (5.26%)  0/96 (0.00%) 
Pneumonia * 1  0/19 (0.00%)  1/96 (1.04%) 
Pneumothorax * 1  0/19 (0.00%)  1/96 (1.04%) 
Skin and subcutaneous tissue disorders     
Paronychia * 1  0/19 (0.00%)  1/96 (1.04%) 
Vascular disorders     
Phlebitis * 1  0/19 (0.00%)  1/96 (1.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827541    
Other Study ID Numbers: B1811048
3074A1-4401
First Submitted: January 20, 2009
First Posted: January 22, 2009
Results First Submitted: December 23, 2011
Results First Posted: February 1, 2012
Last Update Posted: February 1, 2012