Trial Outcomes & Findings for French Study In ICU Patients Treated With Tigecycline (NCT NCT00799591)
NCT ID: NCT00799591
Last Updated: 2011-12-19
Results Overview
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (\>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
Recruitment status
COMPLETED
Target enrollment
156 participants
Primary outcome timeframe
End of Treatment (on the day of last dose of study treatment) or up to 25 months
Results posted on
2011-12-19
Participant Flow
This was a prospective observational study, non-comparative, conducted in 26 French Intensive Care Units (ICUs). Patients who were hospitalized in ICUs and presented with complicated infections of skin or soft tissues or complicated intra-abdominal infections and who met the inclusion criteria of the study were included in the study.
Participant milestones
| Measure |
Tigecycline
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
|
|---|---|
|
Overall Study
STARTED
|
156
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
Tigecycline
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
|
Overall Study
De-escalation of doses
|
20
|
|
Overall Study
Death
|
14
|
|
Overall Study
Technical failure
|
12
|
|
Overall Study
Resistant germ
|
11
|
|
Overall Study
New infection
|
4
|
|
Overall Study
Resistance germ and technical failure
|
2
|
|
Overall Study
Persistance of fever undetermined origin
|
1
|
|
Overall Study
Antibiotic changed, no apparent reason
|
1
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|
Overall Study
Infectious origin not probable
|
1
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Baseline Characteristics
French Study In ICU Patients Treated With Tigecycline
Baseline characteristics by cohort
| Measure |
Tigecycline
n=156 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
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Age Continuous
|
60.1 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Infection: Nosocomial
|
69.3 percentage of participants
n=5 Participants
|
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Percentage of participants per type of infection: Intra-abdominal
Infection: Community
|
30.7 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Peritonitis: Generalized
|
63.2 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Peritonitis: Abscess without peritonitis
|
22.1 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Peritonitis: Localized
|
14.7 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Localization ≥ 10%: Colon
|
37.5 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Intra-abdominal
Localization ≥ 10%: Other
|
12.5 percentage of participants
n=5 Participants
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Percentage of participants per type of infection: Infection of skin and soft tissue
Infection: Nosocomial
|
69.0 percentage of participants
n=5 Participants
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|
Percentage of participants per type of infection: Infection of skin and soft tissue
Infection: Community
|
31.0 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Infection of skin and soft tissue
Dermo-panniculis
|
96.6 percentage of participants
n=5 Participants
|
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Percentage of participants per type of infection: Infection of skin and soft tissue
Localization ≥ 10%: Abdomen
|
52.9 percentage of participants
n=5 Participants
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Percentage of participants per type of infection: Infection of skin and soft tissue
Localization ≥ 10%: Head and neck
|
29.4 percentage of participants
n=5 Participants
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Percentage of participants per type of infection: Infection of skin and soft tissue
Localization ≥ 10%: Perineum
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11.8 percentage of participants
n=5 Participants
|
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Percentage of participants per type of infection: Other infections
Infection: Nosocomial
|
89.3 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Other infections
Infections: Community
|
10.7 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Other infections
Localization ≥ 10%: Lung
|
67.9 percentage of participants
n=5 Participants
|
|
Percentage of participants per type of infection: Other infections
Localization ≥ 10%: Miscellaneous
|
32.1 percentage of participants
n=5 Participants
|
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Mean Simplified Acute Physiology Score II (SAPSII): Integer score
|
43.3 scores on a scale
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Mean Sepsis-related Organ Failure Assessment (SOFA) score
|
7.0 scores on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
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Percentage of participants per reason for choice of treatment with Tigecycline
Polymicrobial infection
|
55.1 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
MRB suspected or identified
|
40.4 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
Renal impairment
|
17.9 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
Multiple sites
|
15.4 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
Failure of previous treatment
|
12.2 percentage of participants
n=5 Participants
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Percentage of participants per reason for choice of treatment with Tigecycline
Allergy or intolerance to other antiobiotics
|
9.6 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
Rescue medication
|
8.3 percentage of participants
n=5 Participants
|
|
Percentage of participants per reason for choice of treatment with Tigecycline
Other
|
6.4 percentage of participants
n=5 Participants
|
|
Percentage of participants per co-morbid (concomitant) diseases
Diabetes mellitus
|
5.1 percentage of participants
n=5 Participants
|
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Percentage of participants per co-morbid (concomitant) diseases
Non-insulin dependent diabetes
|
14.1 percentage of participants
n=5 Participants
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Percentage of participants per co-morbid (concomitant) diseases
Chronic renal failure
|
10.3 percentage of participants
n=5 Participants
|
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Percentage of participants per co-morbid (concomitant) diseases
Chronic hepatic failure Type A
|
80.0 percentage of participants
n=5 Participants
|
|
Percentage of participants per co-morbid (concomitant) diseases
Chronic hepatic failure Type C
|
20.0 percentage of participants
n=5 Participants
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Percentage of participants per co-morbid (concomitant) diseases
Immuno > 10%: Cancer
|
53.8 percentage of participants
n=5 Participants
|
|
Percentage of participants per co-morbid (concomitant) diseases
Immuno > 10%: Use of corticoids
|
15.4 percentage of participants
n=5 Participants
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Percentage of participants per co-morbid (concomitant) diseases
Immuno > 10%: Corticoids plus other Immuno
|
15.4 percentage of participants
n=5 Participants
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Percentage of participants per co-morbid (concomitant) diseases
Immuno > 10%: Other Immuno
|
13.5 percentage of participants
n=5 Participants
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Percentage of participants with antibiotic treatment(s) taken 30 days prior to Tigecycline treatment
Treatment within 30 days prior=No
|
7.1 percentage of participants
n=5 Participants
|
|
Percentage of participants with antibiotic treatment(s) taken 30 days prior to Tigecycline treatment
Treatment within 30 days prior=Yes
|
92.9 percentage of participants
n=5 Participants
|
|
Percentage of participants with microbiological sampling results: positive blood culture
|
11.7 percentage of participants
n=5 Participants
|
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Percentage of participants with microbiological sampling results: direct examination
Gram negative bacilli
|
59.8 percentage of participants
n=5 Participants
|
|
Percentage of participants with microbiological sampling results: direct examination
Gram positive cocci
|
47.1 percentage of participants
n=5 Participants
|
|
Percentage of participants with microbiological sampling results: direct examination
Polymicrobial
|
33.3 percentage of participants
n=5 Participants
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PRIMARY outcome
Timeframe: End of Treatment (on the day of last dose of study treatment) or up to 25 monthsPopulation: Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment.
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (\>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
Outcome measures
| Measure |
Tigecycline
n=156 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Success
|
59.6 percentage of participants
Interval 51.5 to 67.4
|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Clinical Failure - deaths
|
2.6 percentage of participants
Interval 0.7 to 6.4
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|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Clinical Failure - other criteria
|
15.4 percentage of participants
Interval 10.1 to 22.0
|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Undetermined
|
22.4 percentage of participants
Interval 16.2 to 29.8
|
PRIMARY outcome
Timeframe: Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 monthsPopulation: ITT population; N=number of participants with analyzable data at observation.
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (\>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
Outcome measures
| Measure |
Tigecycline
n=145 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Success
|
53.1 percentage of participants
Interval 44.6 to 61.4
|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Clinical Failure
|
22.1 percentage of participants
Interval 15.6 to 29.7
|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Undetermined
|
24.8 percentage of participants
Interval 18.0 to 32.7
|
SECONDARY outcome
Timeframe: Baseline (Inclusion) through last dose of study treatment or up to 25 monthsPopulation: ITT population
Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.
Outcome measures
| Measure |
Tigecycline
n=156 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
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Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Loading dose: 100 mg
|
97.4 percentage of participants
|
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Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Loading dose: Other
|
2.6 percentage of participants
|
|
Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Maintenance dose: 50 mg twice a day
|
93.6 percentage of participants
|
|
Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Maintenance dose: 50 mg twice a day + Other
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Inclusion) through last dose of study treatment or up to 25 monthsPopulation: ITT population
Outcome measures
| Measure |
Tigecycline
n=156 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
|
Mean Duration (Days) of Treatment With Tigecycline
|
10.2 days
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 monthsPopulation: ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.
Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Outcome measures
| Measure |
Tigecycline
n=93 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
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Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Aminoglycosides
|
22.6 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Aminoglycosides: Amikacin
|
14.0 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Penicillins
|
15.1 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Penicillins: Piperacillin / Tazobactam
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 monthsPopulation: ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.
Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Outcome measures
| Measure |
Tigecycline
n=77 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
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|---|---|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Aminoglycosides
|
23.4 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Aminoglycosides: Amikacin
|
14.3 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Penicillins
|
15.6 percentage of participants
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Penicillins: Piperacillin / Tazobactam
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: Post-baseline (Day 1) through last dose of study treatment or up to 25 monthsPopulation: ITT population. N=number of participants with analyzable data at observation.
Microbiological sampling results categorized as a positive blood culture (presence of infection).
Outcome measures
| Measure |
Tigecycline
n=148 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
|
|---|---|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: Post-baseline (Day 1) through last dose of study treatment or up to 25 monthsPopulation: ITT population. N=number of participants with analyzable data at observation; participants may be represented in \>1 category.
Microbiological sampling results categorized according to direct examination (identification of the class of germs).
Outcome measures
| Measure |
Tigecycline
n=33 Participants
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
|
|---|---|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Gram negative bacilli
|
66.7 percentage of participants
|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Gram positive cocci
|
27.3 percentage of participants
|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Polymicrobial
|
18.2 percentage of participants
|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Gram positive bacilli
|
3.0 percentage of participants
|
Adverse Events
Tigecycline
Serious events: 26 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tigecycline
n=156 participants at risk
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
|
|---|---|
|
General disorders
Multiorgan failure
|
5.8%
9/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
General disorders
Drug resistance
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Gastrointestinal disorders
Amount of liquid intra-abdominal localized
|
1.3%
2/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Gastrointestinal disorders
Colitis ischaemia
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Infections and infestations
Septic shock
|
3.8%
6/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Infections and infestations
Purulent discharge
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Vascular disorders
Haemorrhage
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Cardiac disorders
Atrio ventricular dissociation
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Nervous system disorders
Carotid artery dissection
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Psychiatric disorders
Hallucination
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
General disorders
Lack of efficacy of the drug (ineffectiveness of the drug)
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Vascular disorders
Hemorrhagic shock (Shock due to an haemorrhage)
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Injury, poisoning and procedural complications
Arterial injury (lesion of an artery)
|
0.64%
1/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
Other adverse events
| Measure |
Tigecycline
n=156 participants at risk
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
|
|---|---|
|
Gastrointestinal disorders
Vomiting / Nausea
|
1.9%
3/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Infections and infestations
Fungal infection
|
1.3%
2/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Hepatobiliary disorders
Cholestasis
|
1.9%
3/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
2/156 • Baseline (Inclusion) through 7 days after end of study treatment or up to 25 months
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER