Intra-Abdominal Infections, Skin Disease, Infectious, Soft Tissues Infections
Conditions
Keywords
tigecycline, complicated intra-abdominal infections (cIAI), complicated skin and soft tissue infections (cSSTI).
Brief summary
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.
Detailed description
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.
Interventions
DRUGTigecycline
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed by patients prior to this study entry. * 18 years of age or older at the screening visit. * Patients with cIAI or cSSTI. * Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections. * In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.
Exclusion criteria
* Known hypersensibility to tigecycline. * Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. * Use any investigational drug within four weeks of the screening visit. * Uncooperative patients or a history of poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Response of Cure | Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment | 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. |
| Number of Participants With Susceptible Microbiological Pathogens | Baseline and Week 12 | 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. |
| Number of Participants With Eradication of Microbiological Pathogens | Week 12 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 96 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exitus | 1 | 8 |
| Overall Study | Lack of effectiveness | 1 | 0 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Pathogen not susceptible | 1 | 0 |
Baseline characteristics
| Characteristic | Complicated Skin and Soft-tissue Infections | Complicated Intra-Abdominal Infections | Total |
|---|---|---|---|
| Age Continuous | 61.53 years STANDARD_DEVIATION 11.01 | 59.27 years STANDARD_DEVIATION 16.47 | 59.64 years STANDARD_DEVIATION 15.68 |
| Sex: Female, Male Female | 5 Participants | 47 Participants | 52 Participants |
| Sex: Female, Male Male | 14 Participants | 49 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 19 | 23 / 96 |
| serious Total, serious adverse events | 4 / 19 | 28 / 96 |
Outcome results
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.
Time frame: Up to Week 12
Population: Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Complicated Skin and Soft-tissue Infections | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 participants |
| Complicated Skin and Soft-tissue Infections | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| Complicated Intra-Abdominal Infections | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 45 participants |
| Complicated Intra-Abdominal Infections | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 28 participants |
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.
Time frame: Week 12
Population: Data was not analyzed since the number of samples obtained for culture was very low.
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.
Time frame: Baseline and Week 12
Population: Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.
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.
Time frame: Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Complicated Skin and Soft-tissue Infections | Percentage of Participants With Clinical Response of Cure | On Days 2 to 5 (n= 19, 94) | 10.5 percentage of participants |
| Complicated Skin and Soft-tissue Infections | Percentage of Participants With Clinical Response of Cure | On Days 7 to 14 (n= 13, 70) | 46.2 percentage of participants |
| Complicated Skin and Soft-tissue Infections | Percentage of Participants With Clinical Response of Cure | On Days 1 to 3 after end of treatment (n= 19, 96) | 68.4 percentage of participants |
| Complicated Skin and Soft-tissue Infections | Percentage of Participants With Clinical Response of Cure | On Days 21 to 28 (n= 6, 32) | 66.7 percentage of participants |
| Complicated Intra-Abdominal Infections | Percentage of Participants With Clinical Response of Cure | On Days 1 to 3 after end of treatment (n= 19, 96) | 76.0 percentage of participants |
| Complicated Intra-Abdominal Infections | Percentage of Participants With Clinical Response of Cure | On Days 2 to 5 (n= 19, 94) | 18.1 percentage of participants |
| Complicated Intra-Abdominal Infections | Percentage of Participants With Clinical Response of Cure | On Days 7 to 14 (n= 13, 70) | 42.9 percentage of participants |
| Complicated Intra-Abdominal Infections | Percentage of Participants With Clinical Response of Cure | On Days 21 to 28 (n= 6, 32) | 68.8 percentage of participants |