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| ID | Type | Description | Link |
|---|---|---|---|
| 3074A1-4401 |
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This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.
Since around 50 patients were included in Spanish centers involved in the Phase III Tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. With this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients hospitalized because of cIAI or cSSTI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigecycline | Drug | Tigecycline 50 or 100 mg intravenously. Therapy conducted according to the package leaflet of Tygacil and to international treatment guidelines. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response of Cure | 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. | Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized because of complicated intra-abdominal infections (cIAI) or complicated skin and soft tissue infections (cSSTI), in the usual health care setting
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23772047 | Derived | Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140. | |
| 23772045 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With Clinical Response of Cure | 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. | 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. | Posted | Number | percentage of participants | Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D012874 | Skin Diseases, Infectious |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
|
| Number of Participants With Susceptible Microbiological Pathogens |
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. |
| Baseline and Week 12 |
| Number of Participants With Eradication of Microbiological Pathogens | 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. | Week 12 |
| Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143. |
| 23772042 | Derived | Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141. |
| Pathogen not susceptible |
|
| Lack of effectiveness |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Number of Participants With Susceptible Microbiological Pathogens | 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. | Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low. | Posted | Number | participants | Baseline and Week 12 |
|
|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit. | Posted | Number | participants | Up to Week 12 |
|
|
|
| Secondary | Number of Participants With Eradication of Microbiological Pathogens | 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. | Data was not analyzed since the number of samples obtained for culture was very low. | Posted | Number | participants | Week 12 |
|
|
| 4 |
| 19 |
| 7 |
| 19 |
| EG001 | 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. | 28 | 96 | 23 | 96 |
| Multi-organ failure | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Wound evisceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Treatment failure | General disorders | MedDRA | Non-systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| C-reactive protein | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood creatinine abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Biliary tract disorder | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Aplasia | General disorders | MedDRA | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal sepsis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Non specified | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Wound infection | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| White blood cell count | Investigations | MedDRA | Non-systematic Assessment |
|
| Intestinal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| C-reactive protein | Investigations | MedDRA | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Device related infection | General disorders | MedDRA | Non-systematic Assessment |
|
| White blood cell analysis increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Transaminases abnormal | Investigations | MedDRA | Non-systematic Assessment |
|
| Soft tissue infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Postoperative wound infection | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Paronychia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Biliary fistula | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |